APALUTAMIDIN ja SÄTEILYN BIOMARKER-KOE TOISTUVAN ETUrauhassyövän varalta
Vaiheen II, kaksoissokkoutettu, lumekontrolloitu satunnaistettu koe pelastavasta sädehoidosta, jossa on tai ei ole tehostettua antiandrogeenihoitoa apalutamidilla toistuvassa eturauhassyövässä
This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer compared to radiation therapy alone.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
PRIMARY OBJECTIVE:
I. To determine whether, in men with post-prostatectomy prostate-specific antigen (PSA) recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
SECONDARY OBJECTIVES:
I. To assess whether molecular stratification by the PAM50 gene expression clustering will identify subsets of prostate cancer (luminal A or basal, luminal B) which derive the greatest benefit from anti-androgen therapy.
II. To assess overall survival. III. To assess cancer-specific mortality. IV. To assess metastasis-free survival. V. To assess distant metastasis. VI. To assess local-regional progression. VII. To assess PSA nadir during first year of treatment and prior to initiation of any hormonal salvage therapy.
VIII. To assess initiation of salvage hormonal therapy. IX. To assess PSA with a non-castrate testosterone at 1 and 3 years post randomization: PSA < 0.1 ng/ml and testosterone >= 50 ng/dl.
X. To assess acute and late physician-reported morbidity (per the Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) after SRT +/- apalutamide.
XI. To assess acute and late patient-reported symptomatic adverse events morbidity (per the patient reported outcomes [PRO]-CTCAE) after SRT +/- apalutamide.
XII. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.
EXPLORATORY OBJECTIVE:
I. To assess the prognostic and predictive value of the genomic classifier Decipher.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo orally (PO) once daily (QD) on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then yearly thereafter.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Alberta
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Calgary, Alberta, Kanada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- University Health Network-Princess Margaret Hospital
-
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Quebec
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Montreal, Quebec, Kanada, H3H 2R9
- The Research Institute of the McGill University Health Centre (MUHC)
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Montreal, Quebec, Kanada, H1T 2M4
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
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Québec, Quebec, Kanada, G1R 2J6
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
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Sherbrooke, Quebec, Kanada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre
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Arizona
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Gilbert, Arizona, Yhdysvallat, 85297
- Arizona Center for Cancer Care - Gilbert
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Peoria, Arizona, Yhdysvallat, 85381
- Arizona Center for Cancer Care-Peoria
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Scottsdale, Arizona, Yhdysvallat, 85258
- Arizona Center for Cancer Care - Scottsdale
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Surprise, Arizona, Yhdysvallat, 85374
- Arizona Center for Cancer Care-Surprise
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Arkansas
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Little Rock, Arkansas, Yhdysvallat, 72205
- University of Arkansas for Medical Sciences
-
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California
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Berkeley, California, Yhdysvallat, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Greenbrae, California, Yhdysvallat, 94904
- Marin General Hospital
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Los Angeles, California, Yhdysvallat, 90033
- USC / Norris Comprehensive Cancer Center
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Los Angeles, California, Yhdysvallat, 90048
- Cedars Sinai Medical Center
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Los Angeles, California, Yhdysvallat, 90033
- Los Angeles General Medical Center
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Roseville, California, Yhdysvallat, 95661
- Sutter Cancer Centers Radiation Oncology Services-Roseville
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Sacramento, California, Yhdysvallat, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, Yhdysvallat, 95817
- University of California Davis Comprehensive Cancer Center
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Truckee, California, Yhdysvallat, 96161
- Gene Upshaw Memorial Tahoe Forest Cancer Center
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Vallejo, California, Yhdysvallat, 94589
- Sutter Solano Medical Center/Cancer Center
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Colorado
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Aurora, Colorado, Yhdysvallat, 80045
- UCHealth University of Colorado Hospital
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Colorado Springs, Colorado, Yhdysvallat, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Yhdysvallat, 80909
- UCHealth Memorial Hospital Central
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Colorado Springs, Colorado, Yhdysvallat, 80920
- Memorial Hospital North
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Fort Collins, Colorado, Yhdysvallat, 80524
- Poudre Valley Hospital
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Fort Collins, Colorado, Yhdysvallat, 80528
- Cancer Care and Hematology-Fort Collins
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Glenwood Springs, Colorado, Yhdysvallat, 81601
- Valley View Hospital Cancer Center
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Greeley, Colorado, Yhdysvallat, 80631
- UCHealth Greeley Hospital
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Loveland, Colorado, Yhdysvallat, 80538
- Medical Center of the Rockies
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Connecticut
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Stamford, Connecticut, Yhdysvallat, 06904
- Stamford Hospital/Bennett Cancer Center
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Delaware
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Newark, Delaware, Yhdysvallat, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Yhdysvallat, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, Yhdysvallat, 19971
- Beebe Health Campus
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District of Columbia
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Washington D.C., District of Columbia, Yhdysvallat, 20037
- George Washington University Medical Center
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Florida
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Altamonte Springs, Florida, Yhdysvallat, 32701
- AdventHealth Altamonte
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Fort Myers, Florida, Yhdysvallat, 33905
- Regional Cancer Center-Lee Memorial Health System
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Kissimmee, Florida, Yhdysvallat, 34744
- AdventHealth Kissimmee
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Orlando, Florida, Yhdysvallat, 32803
- AdventHealth Orlando
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Orlando, Florida, Yhdysvallat, 32822
- AdventHealth East Orlando
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Weston, Florida, Yhdysvallat, 33331
- Cleveland Clinic-Weston
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Winter Park, Florida, Yhdysvallat, 32792
- AdventHealth Winter Park
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Yhdysvallat, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Yhdysvallat, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Yhdysvallat, 30303
- Grady Health System
-
Atlanta, Georgia, Yhdysvallat, 30342
- Northside Hospital
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Augusta, Georgia, Yhdysvallat, 30912
- Augusta University Medical Center
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Savannah, Georgia, Yhdysvallat, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Idaho
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Boise, Idaho, Yhdysvallat, 83712
- Saint Luke's Cancer Institute - Boise
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Fruitland, Idaho, Yhdysvallat, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Yhdysvallat, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Yhdysvallat, 83687
- Saint Luke's Cancer Institute - Nampa
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Twin Falls, Idaho, Yhdysvallat, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Chicago, Illinois, Yhdysvallat, 60612
- University of Illinois
-
Chicago, Illinois, Yhdysvallat, 60612
- Rush MD Anderson Cancer Center
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Decatur, Illinois, Yhdysvallat, 62526
- Decatur Memorial Hospital
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Effingham, Illinois, Yhdysvallat, 62401
- Crossroads Cancer Center
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Hines, Illinois, Yhdysvallat, 60141
- Edward Hines Jr VA Hospital
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Maywood, Illinois, Yhdysvallat, 60153
- Loyola University Medical Center
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Peoria, Illinois, Yhdysvallat, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Yhdysvallat, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Yhdysvallat, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Springfield, Illinois, Yhdysvallat, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Yhdysvallat, 62702
- Springfield Clinic
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Springfield, Illinois, Yhdysvallat, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Yhdysvallat, 61801
- Carle Cancer Center
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Indiana
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Fort Wayne, Indiana, Yhdysvallat, 46805
- Parkview Hospital Randallia
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Fort Wayne, Indiana, Yhdysvallat, 46845
- Parkview Regional Medical Center
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Goshen, Indiana, Yhdysvallat, 46526
- Goshen Center for Cancer Care
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Richmond, Indiana, Yhdysvallat, 47374
- Reid Health
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Iowa
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Clive, Iowa, Yhdysvallat, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Yhdysvallat, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Creston, Iowa, Yhdysvallat, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Yhdysvallat, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Yhdysvallat, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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West Des Moines, Iowa, Yhdysvallat, 50266
- Mercy Medical Center-West Lakes
-
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Kansas
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Kansas City, Kansas, Yhdysvallat, 66160
- University of Kansas Cancer Center
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Olathe, Kansas, Yhdysvallat, 66061
- The University of Kansas Cancer Center - Olathe
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Overland Park, Kansas, Yhdysvallat, 66210
- University of Kansas Cancer Center-Overland Park
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Salina, Kansas, Yhdysvallat, 67401
- Salina Regional Health Center
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Westwood, Kansas, Yhdysvallat, 66205
- University of Kansas Hospital-Westwood Cancer Center
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Kentucky
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Lexington, Kentucky, Yhdysvallat, 40536
- University of Kentucky/Markey Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Yhdysvallat, 70809
- Mary Bird Perkins Cancer Center
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Metairie, Louisiana, Yhdysvallat, 70006
- East Jefferson General Hospital
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Metairie, Louisiana, Yhdysvallat, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
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Maine
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Bath, Maine, Yhdysvallat, 04530
- MaineHealth Coastal Cancer Treatment Center
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Belfast, Maine, Yhdysvallat, 04915
- MaineHealth Waldo Hospital
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Biddeford, Maine, Yhdysvallat, 04005
- MaineHealth Maine Medical Center - Biddeford
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Brewer, Maine, Yhdysvallat, 04412
- Lafayette Family Cancer Center-EMMC
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Norway, Maine, Yhdysvallat, 04268
- MaineHealth Stephens Hospital
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Portland, Maine, Yhdysvallat, 04102
- MaineHealth Maine Medical Center - Portland
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Rockport, Maine, Yhdysvallat, 04856
- Penobscot Bay Medical Center
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Sanford, Maine, Yhdysvallat, 04073
- MaineHealth Cancer Care Center of York County
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Sanford, Maine, Yhdysvallat, 04073
- MaineHealth Cancer Care and IV Therapy - Sanford
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Scarborough, Maine, Yhdysvallat, 04074
- MaineHealth Maine Medical Center- Scarborough
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South Portland, Maine, Yhdysvallat, 04106
- MaineHealth Cancer Care and IV Therapy - South Portland
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21201
- University of Maryland/Greenebaum Cancer Center
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Baltimore, Maryland, Yhdysvallat, 21229
- Saint Agnes Hospital
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Columbia, Maryland, Yhdysvallat, 21044
- Central Maryland Radiation Oncology in Howard County
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Glen Burnie, Maryland, Yhdysvallat, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
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Massachusetts
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Burlington, Massachusetts, Yhdysvallat, 01805
- Lahey Hospital and Medical Center
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Lowell, Massachusetts, Yhdysvallat, 01854
- Lowell General Hospital
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48109
- University of Michigan Rogel Cancer Center
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Ann Arbor, Michigan, Yhdysvallat, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Yhdysvallat, 49017
- Bronson Battle Creek
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Brighton, Michigan, Yhdysvallat, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Yhdysvallat, 48188
- Trinity Health Medical Center - Canton
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Chelsea, Michigan, Yhdysvallat, 48118
- Chelsea Hospital
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Clarkston, Michigan, Yhdysvallat, 48346
- Michigan Healthcare Professionals Clarkston
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Clinton Township, Michigan, Yhdysvallat, 48038
- Henry Ford Macomb Hospital-Clinton Township
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Dearborn, Michigan, Yhdysvallat, 48124
- Corewell Health Dearborn Hospital
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Detroit, Michigan, Yhdysvallat, 48202
- Henry Ford Hospital
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East Lansing, Michigan, Yhdysvallat, 48823
- Michigan State University
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Farmington Hills, Michigan, Yhdysvallat, 48334
- Michigan Healthcare Professionals Farmington
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Grand Rapids, Michigan, Yhdysvallat, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Yhdysvallat, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Yhdysvallat, 49007
- West Michigan Cancer Center
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Lansing, Michigan, Yhdysvallat, 48912
- University of Michigan Health - Sparrow Lansing
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Niles, Michigan, Yhdysvallat, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Reed City, Michigan, Yhdysvallat, 49677
- Corewell Health Reed City Hospital
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Royal Oak, Michigan, Yhdysvallat, 48073
- Corewell Health William Beaumont University Hospital
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Saint Joseph, Michigan, Yhdysvallat, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, Yhdysvallat, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, Yhdysvallat, 49684
- Munson Medical Center
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Troy, Michigan, Yhdysvallat, 48098
- Michigan Healthcare Professionals Troy
-
Troy, Michigan, Yhdysvallat, 48085
- Corewell Health Beaumont Troy Hospital
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West Bloomfield, Michigan, Yhdysvallat, 48322
- Henry Ford West Bloomfield Hospital
-
Wyoming, Michigan, Yhdysvallat, 49519
- University of Michigan Health - West
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Minnesota
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Albert Lea, Minnesota, Yhdysvallat, 56007
- Mayo Clinic Health System in Albert Lea
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Burnsville, Minnesota, Yhdysvallat, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Yhdysvallat, 55433
- Mercy Hospital
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Edina, Minnesota, Yhdysvallat, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Yhdysvallat, 55432
- Unity Hospital
-
Mankato, Minnesota, Yhdysvallat, 56001
- Mayo Clinic Health Systems-Mankato
-
Maple Grove, Minnesota, Yhdysvallat, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Yhdysvallat, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Yhdysvallat, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Yhdysvallat, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Yhdysvallat, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Yhdysvallat, 55454
- Health Partners Inc
-
Minneapolis, Minnesota, Yhdysvallat, 55417
- Minneapolis VA Medical Center
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Monticello, Minnesota, Yhdysvallat, 55362
- Monticello Cancer Center
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Robbinsdale, Minnesota, Yhdysvallat, 55422
- North Memorial Medical Health Center
-
Rochester, Minnesota, Yhdysvallat, 55905
- Mayo Clinic in Rochester
-
Saint Cloud, Minnesota, Yhdysvallat, 56303
- Coborn Cancer Center at Saint Cloud Hospital
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Saint Louis Park, Minnesota, Yhdysvallat, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Yhdysvallat, 55101
- Regions Hospital
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Saint Paul, Minnesota, Yhdysvallat, 55102
- United Hospital
-
Shakopee, Minnesota, Yhdysvallat, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Yhdysvallat, 55082
- Lakeview Hospital
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Waconia, Minnesota, Yhdysvallat, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Yhdysvallat, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Yhdysvallat, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Wyoming, Minnesota, Yhdysvallat, 55092
- Fairview Lakes Medical Center
-
-
Mississippi
-
Jackson, Mississippi, Yhdysvallat, 39216
- University of Mississippi Medical Center
-
-
Missouri
-
Cape Girardeau, Missouri, Yhdysvallat, 63703
- Mercy Cancer Center - Cape Girardeau
-
City of Saint Peters, Missouri, Yhdysvallat, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, Yhdysvallat, 63141
- Siteman Cancer Center at West County Hospital
-
Jefferson City, Missouri, Yhdysvallat, 65109
- MU Health Care Goldschmidt Cancer Center
-
Kansas City, Missouri, Yhdysvallat, 64128
- Kansas City Veterans Affairs Medical Center
-
Kansas City, Missouri, Yhdysvallat, 64154
- University of Kansas Cancer Center - North
-
Lee's Summit, Missouri, Yhdysvallat, 64064
- University of Kansas Cancer Center - Lee's Summit
-
Rolla, Missouri, Yhdysvallat, 65401
- Phelps Health Delbert Day Cancer Institute
-
St Louis, Missouri, Yhdysvallat, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Yhdysvallat, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Yhdysvallat, 63141
- Mercy Hospital Saint Louis
-
-
Montana
-
Billings, Montana, Yhdysvallat, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Yhdysvallat, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Yhdysvallat, 59405
- Benefis Sletten Cancer Institute
-
-
Nebraska
-
Omaha, Nebraska, Yhdysvallat, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Yhdysvallat, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Yhdysvallat, 68124
- Alegent Health Bergan Mercy Medical Center
-
-
Nevada
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Henderson, Nevada, Yhdysvallat, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Yhdysvallat, 89052
- OptumCare Cancer Care at Seven Hills
-
Henderson, Nevada, Yhdysvallat, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Yhdysvallat, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Yhdysvallat, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Yhdysvallat, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Yhdysvallat, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Yhdysvallat, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Yhdysvallat, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Yhdysvallat, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Yhdysvallat, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Yhdysvallat, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Yhdysvallat, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Yhdysvallat, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Yhdysvallat, 89148
- OptumCare Cancer Care at Fort Apache
-
Las Vegas, Nevada, Yhdysvallat, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Yhdysvallat, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Yhdysvallat, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Yhdysvallat, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Yhdysvallat, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Yhdysvallat, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Yhdysvallat, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Yhdysvallat, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Yhdysvallat, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Yhdysvallat, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Yhdysvallat, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Yhdysvallat, 89169
- University Cancer Center
-
Las Vegas, Nevada, Yhdysvallat, 89128
- Oncology Las Vegas - Tenaya
-
Pahrump, Nevada, Yhdysvallat, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Yhdysvallat, 89509
- Radiation Oncology Associates
-
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New Hampshire
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Concord, New Hampshire, Yhdysvallat, 03301
- New Hampshire Oncology Hematology PA-Concord
-
Lebanon, New Hampshire, Yhdysvallat, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Manchester, New Hampshire, Yhdysvallat, 03103
- Solinsky Center for Cancer Care
-
-
New Jersey
-
Mount Holly, New Jersey, Yhdysvallat, 08060
- Virtua Memorial
-
New Brunswick, New Jersey, Yhdysvallat, 08903
- Rutgers Cancer Institute of New Jersey
-
Sewell, New Jersey, Yhdysvallat, 08080
- Sidney Kimmel Cancer Center Washington Township
-
Somerville, New Jersey, Yhdysvallat, 08876
- Robert Wood Johnson University Hospital Somerset
-
-
New Mexico
-
Albuquerque, New Mexico, Yhdysvallat, 87109
- New Mexico Oncology Hematology Consultants
-
Albuquerque, New Mexico, Yhdysvallat, 87106
- University of New Mexico Cancer Center
-
-
New York
-
Brooklyn, New York, Yhdysvallat, 11215
- New York-Presbyterian/Brooklyn Methodist Hospital
-
Canandaigua, New York, Yhdysvallat, 14424
- Sands Cancer Center
-
Cooperstown, New York, Yhdysvallat, 13326
- Mary Imogene Bassett Hospital
-
New York, New York, Yhdysvallat, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, Yhdysvallat, 14642
- University of Rochester
-
Rochester, New York, Yhdysvallat, 14620
- Highland Hospital
-
Rochester, New York, Yhdysvallat, 14606
- Wilmot Cancer Institute Radiation Oncology at Greece
-
Stony Brook, New York, Yhdysvallat, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Yhdysvallat, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Yhdysvallat, 10468
- James J Peters VA Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Yhdysvallat, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Supply, North Carolina, Yhdysvallat, 28462
- Novant Cancer Institute Radiation Oncology - Supply
-
Wilmington, North Carolina, Yhdysvallat, 28401
- Novant Health New Hanover Regional Medical Center
-
Wilmington, North Carolina, Yhdysvallat, 28401
- Novant Health Cancer Institute Radiation Oncology - Wilmington
-
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Ohio
-
Akron, Ohio, Yhdysvallat, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, Yhdysvallat, 44304
- Summa Health System - Akron Campus
-
Beachwood, Ohio, Yhdysvallat, 44122
- UHHS-Chagrin Highlands Medical Center
-
Beavercreek, Ohio, Yhdysvallat, 45431
- Indu and Raj Soin Medical Center
-
Centerville, Ohio, Yhdysvallat, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Yhdysvallat, 45459
- Dayton Physicians LLC-Miami Valley South
-
Chardon, Ohio, Yhdysvallat, 44024
- Geauga Hospital
-
Cincinnati, Ohio, Yhdysvallat, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Yhdysvallat, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cleveland, Ohio, Yhdysvallat, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Yhdysvallat, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Yhdysvallat, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Yhdysvallat, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Yhdysvallat, 43219
- The Mark H Zangmeister Center
-
Dayton, Ohio, Yhdysvallat, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, Yhdysvallat, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Yhdysvallat, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Yhdysvallat, 45415
- Dayton Physician LLC - Englewood
-
Findlay, Ohio, Yhdysvallat, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Yhdysvallat, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Yhdysvallat, 45840
- Orion Cancer Care
-
Franklin, Ohio, Yhdysvallat, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Yhdysvallat, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Yhdysvallat, 45331
- Wayne Hospital
-
Greenville, Ohio, Yhdysvallat, 45331
- Dayton Physicians LLC-Wayne
-
Kettering, Ohio, Yhdysvallat, 45429
- Kettering Medical Center
-
Kettering, Ohio, Yhdysvallat, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, Yhdysvallat, 45420
- First Dayton Cancer Care
-
Mansfield, Ohio, Yhdysvallat, 44906
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, Yhdysvallat, 44124
- Hillcrest Hospital Cancer Center
-
Mentor, Ohio, Yhdysvallat, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
Middleburg Heights, Ohio, Yhdysvallat, 44130
- UH Seidman Cancer Center at Southwest General Hospital
-
Parma, Ohio, Yhdysvallat, 44129
- University Hospitals Parma Medical Center
-
Ravenna, Ohio, Yhdysvallat, 44266
- University Hospitals Portage Medical Center
-
Sandusky, Ohio, Yhdysvallat, 44870
- North Coast Cancer Care
-
Sandusky, Ohio, Yhdysvallat, 44870
- UH Seidman Cancer Center at Firelands Regional Medical Center
-
Springfield, Ohio, Yhdysvallat, 45504
- Springfield Regional Cancer Center
-
Springfield, Ohio, Yhdysvallat, 45504
- Springfield Regional Medical Center
-
Strongsville, Ohio, Yhdysvallat, 44136
- Cleveland Clinic Cancer Center Strongsville
-
Troy, Ohio, Yhdysvallat, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Yhdysvallat, 45373
- Dayton Physicians LLC - Troy
-
West Chester, Ohio, Yhdysvallat, 45069
- University of Cincinnati Cancer Center-West Chester
-
Westlake, Ohio, Yhdysvallat, 44145
- UHHS-Westlake Medical Center
-
Wooster, Ohio, Yhdysvallat, 44691
- Cleveland Clinic Wooster Family Health and Surgery Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Yhdysvallat, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Yhdysvallat, 74133
- Cancer Treatment Centers of America
-
-
Oregon
-
Gresham, Oregon, Yhdysvallat, 97030
- Legacy Mount Hood Medical Center
-
Portland, Oregon, Yhdysvallat, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
-
Pennsylvania
-
Altoona, Pennsylvania, Yhdysvallat, 16601
- UPMC Altoona
-
Beaver, Pennsylvania, Yhdysvallat, 15009
- UPMC-Heritage Valley Health System Beaver
-
Bethlehem, Pennsylvania, Yhdysvallat, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Chadds Ford, Pennsylvania, Yhdysvallat, 19317
- Christiana Care Health System-Concord Health Center
-
Dunmore, Pennsylvania, Yhdysvallat, 18512
- Northeast Radiation Oncology Center
-
Farrell, Pennsylvania, Yhdysvallat, 16121
- UPMC Cancer Center at UPMC Horizon
-
Greensburg, Pennsylvania, Yhdysvallat, 15601
- UPMC Cancer Centers - Arnold Palmer Pavilion
-
Harrisburg, Pennsylvania, Yhdysvallat, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Hershey, Pennsylvania, Yhdysvallat, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Johnstown, Pennsylvania, Yhdysvallat, 15901
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
-
McKeesport, Pennsylvania, Yhdysvallat, 15132
- UPMC Cancer Center at UPMC McKeesport
-
Monroeville, Pennsylvania, Yhdysvallat, 15146
- UPMC Cancer Center - Monroeville
-
Moon Township, Pennsylvania, Yhdysvallat, 15108
- UPMC Hillman Cancer Center in Coraopolis
-
Philadelphia, Pennsylvania, Yhdysvallat, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Yhdysvallat, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Yhdysvallat, 19114
- Jefferson Torresdale Hospital
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15213
- UPMC-Magee Womens Hospital
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15232
- UPMC-Shadyside Hospital
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15215
- UPMC-Saint Margaret
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15237
- UPMC-Passavant Hospital
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15243
- UPMC-Saint Clair Hospital Cancer Center
-
Sayre, Pennsylvania, Yhdysvallat, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
Seneca, Pennsylvania, Yhdysvallat, 16346
- UPMC Cancer Center at UPMC Northwest
-
Uniontown, Pennsylvania, Yhdysvallat, 15401
- UPMC Uniontown Hospital Radiation Oncology
-
Washington, Pennsylvania, Yhdysvallat, 15301
- UPMC Washington Hospital Radiation Oncology
-
West Reading, Pennsylvania, Yhdysvallat, 19611
- Reading Hospital
-
Willow Grove, Pennsylvania, Yhdysvallat, 19090
- Asplundh Cancer Pavilion
-
-
South Carolina
-
Boiling Springs, South Carolina, Yhdysvallat, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Greenville, South Carolina, Yhdysvallat, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Yhdysvallat, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenwood, South Carolina, Yhdysvallat, 29646
- Self Regional Healthcare
-
Greer, South Carolina, Yhdysvallat, 29650
- Prisma Health Cancer Institute - Greer
-
Hilton Head Island, South Carolina, Yhdysvallat, 29926
- The Radiation Oncology Center-Hilton Head/Bluffton
-
Seneca, South Carolina, Yhdysvallat, 29672
- Prisma Health Cancer Institute - Seneca
-
-
South Dakota
-
Rapid City, South Dakota, Yhdysvallat, 57701
- Rapid City Regional Hospital
-
-
Tennessee
-
Germantown, Tennessee, Yhdysvallat, 38138
- The West Clinic - Wolf River
-
Nashville, Tennessee, Yhdysvallat, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
-
Dallas, Texas, Yhdysvallat, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
San Antonio, Texas, Yhdysvallat, 78229
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Yhdysvallat, 78229
- Audie L Murphy VA Hospital
-
-
Utah
-
American Fork, Utah, Yhdysvallat, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, Yhdysvallat, 84720
- Sandra L Maxwell Cancer Center
-
Farmington, Utah, Yhdysvallat, 84025
- Farmington Health Center
-
Logan, Utah, Yhdysvallat, 84321
- Logan Regional Hospital
-
Murray, Utah, Yhdysvallat, 84107
- Intermountain Medical Center
-
Ogden, Utah, Yhdysvallat, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Yhdysvallat, 84604
- Utah Valley Regional Medical Center
-
Riverton, Utah, Yhdysvallat, 84065
- Riverton Hospital
-
Salt Lake City, Utah, Yhdysvallat, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, Yhdysvallat, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, Yhdysvallat, 84143
- LDS Hospital
-
St. George, Utah, Yhdysvallat, 84770
- Saint George Regional Medical Center
-
-
Vermont
-
Bennington, Vermont, Yhdysvallat, 05201
- Southwestern Vermont Medical Center
-
Berlin Corners, Vermont, Yhdysvallat, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, Yhdysvallat, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, Yhdysvallat, 05405
- University of Vermont and State Agricultural College
-
Saint Johnsbury, Vermont, Yhdysvallat, 05819
- Dartmouth Cancer Center - North
-
-
Virginia
-
Portsmouth, Virginia, Yhdysvallat, 23708-2197
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Yhdysvallat, 23249
- Hunter Holmes McGuire Veterans Administration Medical Center
-
-
Washington
-
Bellingham, Washington, Yhdysvallat, 98225
- PeaceHealth Saint Joseph Medical Center
-
Vancouver, Washington, Yhdysvallat, 98686
- Legacy Salmon Creek Hospital
-
Walla Walla, Washington, Yhdysvallat, 99362
- Providence Saint Mary Regional Cancer Center
-
-
West Virginia
-
Morgantown, West Virginia, Yhdysvallat, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, Yhdysvallat, 26101
- Camden Clark Medical Center
-
-
Wisconsin
-
Eau Claire, Wisconsin, Yhdysvallat, 54701
- Marshfield Medical Center-EC Cancer Center
-
Grafton, Wisconsin, Yhdysvallat, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Yhdysvallat, 54311
- Aurora BayCare Medical Center
-
Kenosha, Wisconsin, Yhdysvallat, 53142
- Aurora Cancer Care-Kenosha South
-
Marshfield, Wisconsin, Yhdysvallat, 54449
- Marshfield Medical Center-Marshfield
-
Menomonee Falls, Wisconsin, Yhdysvallat, 53051
- Froedtert Menomonee Falls Hospital
-
Milwaukee, Wisconsin, Yhdysvallat, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Yhdysvallat, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Yhdysvallat, 53295
- Zablocki Veterans Administration Medical Center
-
Minocqua, Wisconsin, Yhdysvallat, 54548
- Marshfield Medical Center - Minocqua
-
New Richmond, Wisconsin, Yhdysvallat, 54017
- Cancer Center of Western Wisconsin
-
Oshkosh, Wisconsin, Yhdysvallat, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Rice Lake, Wisconsin, Yhdysvallat, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Yhdysvallat, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Stevens Point, Wisconsin, Yhdysvallat, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Summit, Wisconsin, Yhdysvallat, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Yhdysvallat, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
West Allis, Wisconsin, Yhdysvallat, 53227
- Aurora West Allis Medical Center
-
West Bend, Wisconsin, Yhdysvallat, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Weston, Wisconsin, Yhdysvallat, 54476
- Marshfield Medical Center - Weston
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
-
Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
-
Post-prostatectomy patients with a detectable serum PSA (>= 0.1, but =< 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:
-
Gleason score 7-10 (International Society of Urological Pathology [ISUP] grade group 2 to 5)
-
ISUP grade group:
- Grade group 1 = Gleason score =< 6,
- Grade group 2 = Gleason score 3 + 4 = 7,
- Grade group 3 = Gleason score 4 + 3 = 7,
- Grade group 4 = Gleason score 8,
- Grade group 5 = Gleason scores 9 and 10
-
>= T3a disease
-
Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of > 0.04 but < 0.2 ng/mL (PSA nadir)
-
-
pN0 or pNx
-
History/physical examination within 90 days prior to Step 1 registration
-
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
-
Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation and for GenomeDx to provide the subtyping needed for stratification
-
Prior androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to Step 1 registration and given for =< 90 days duration
- For example: patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date
- Please note: finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility
-
Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
-
Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
-
Serum albumin >= 3.0 g/dL within 90 days prior to Step 1 registration
-
Glomerular filtration rate (GFR) >= 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to Step 1 registration
-
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
-
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x ULN within 90 days prior to Step 1 registration
-
Testosterone > 50 ng/dL within 90 days prior to Step 1 registration
-
Concomitant medications known to lower the seizure threshold discontinued or substituted at least 4 weeks (30 days) prior to Step 1 registration
-
The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
-
The patient must agree not to donate sperm during the study treatment and for 3 months after receiving the last dose of study drug
-
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:
-
PRIOR TO STEP 1 REGISTRATION:
-
Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
-
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
-
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
-
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
-
History of any of the following:
- Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to Step 1 registration)
- History of documented inflammatory bowel disease
- Transmural myocardial infarction within the last 4 months prior to Step 1 registration
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration
- History of any condition that in the opinion of the investigator, would preclude participation in this study
-
Current evidence of any of the following:
- Known gastrointestinal disorder affecting absorption of oral medications
- Active uncontrolled infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)
- Uncontrolled hypertension
- Any current condition that in the opinion of the investigator, would preclude participation in this study
-
Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is not allowed
-
HIV positive with CD4 count < 200 cells/microliter within 30 days prior to registration
-
HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count; (Note: HIV testing is not required for eligibility for this protocol as it is self-reported; this exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART)
-
Patients must not plan to participate in any other clinical trials while receiving treatment on this study or being followed post-protocol therapy
-
PRIOR TO STEP 2 REGISTRATION:
-
For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Arm 1 (radiation therapy, placebo)
Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
Given PO Undergo external beam radiation therapy
Muut nimet:
|
|
Kokeellinen: Arm 2 (radiation therapy, apalutamide)
Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
Undergo external beam radiation therapy
Muut nimet:
Given PO
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
Aikaikkuna: From randomization to biochemical progression or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
Biochemical progression is defined as the first occurrence of the following:
|
From randomization to biochemical progression or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of Participants With Undetectable PSA (< 0.1) and Non-castrate Testosterone (≥ 50 ng/dl) at One and Three Years
Aikaikkuna: One and three years
|
One and three years
|
|
|
Percentage of Participants Alive (Overall Survival)
Aikaikkuna: From randomization to death or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. |
From randomization to death or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
|
Percentage of Participants Who Have Died Due to Prostate Cancer (Cancer-specific Mortality (CSM))
Aikaikkuna: From the date of randomization to the date of death due to prostate cancer or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
Prostate cancer death rates were estimated using the cumulative incidence method in which death from other causes is treated as a competing risk and alive patients are censored. |
From the date of randomization to the date of death due to prostate cancer or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
|
Percentage of Participants Alive Without Distant Metastases (Metastasis-free Survival (MFS))
Aikaikkuna: From randomization to date of first distant metastasis or death, or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
Distant metastases are defined as clinical or radiographic appearance of disseminated disease. MFS rates are estimated using the Kaplan-Meier method, censoring participants alive without metastases at time of analysis. |
From randomization to date of first distant metastasis or death, or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
|
Percentage of Participants With Distant Metastasis
Aikaikkuna: From randomization to date of first distant metastasis or death, or last follow-up if alive at time of analysis. Median follow-up at time of analysis was 5.0 years. Five-year rates are presented.
|
Distant metastases are defined as clinical or radiographic appearance of disseminated disease. Distant metastasis rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive without distant metastases are censored at last known follow-up. |
From randomization to date of first distant metastasis or death, or last follow-up if alive at time of analysis. Median follow-up at time of analysis was 5.0 years. Five-year rates are presented.
|
|
Percentage of Participants Wtih Local-regional Progression
Aikaikkuna: From randomization to date of first local or regional recurrence or death, or last follow-up if alive at time of analysis. Median follow-up at time of analysis was 5.0 years. Five-year rates are presented.
|
Local-regional progression is defined as recurrence within the pelvis including lymph nodes below the iliac bifurcation. Local-regional progression rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive without local-regional progression are censored at last known follow-up. |
From randomization to date of first local or regional recurrence or death, or last follow-up if alive at time of analysis. Median follow-up at time of analysis was 5.0 years. Five-year rates are presented.
|
|
PSA Nadir During First Year of Treatment and Prior to Initiation of Any Hormonal Salvage Therapy
Aikaikkuna: First year of treatment
|
Will be compared between the two groups using a two-sample t-test. |
First year of treatment
|
|
Percentage of Participants That Started Salvage Hormonal Therapy
Aikaikkuna: From randomization to initiation of salvage hormonal therapy or death, whichever occurs first, or last follow-up if alive at time of analysis. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
Initiation of salvage hormone therapy (LHRH analogues or non-study anti-androgens) that occurs after completion of SRT. Salvage hormonal therapy rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive who have not started salvage hormonal therapy are censored at last known follow-up. |
From randomization to initiation of salvage hormonal therapy or death, whichever occurs first, or last follow-up if alive at time of analysis. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
|
|
Number of Participants With Grade 3+ Adverse Events Occurring Within 30 Days After the Completion of RT
Aikaikkuna: Up to 30 days after radiation therapy, which lasts approximately 7-8 weeks from treatment start.
|
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
Up to 30 days after radiation therapy, which lasts approximately 7-8 weeks from treatment start.
|
|
Number of Participants With Grade 3+ Adverse Events Occurring More Than 30 Days After the Completion of Radiation Therapy
Aikaikkuna: From the end of radiation therapy (approximately 7-8 weeks from treatment start) to last follow-up. Median follow-up at time of analysis among surviving patients was 5.0 years.
|
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
From the end of radiation therapy (approximately 7-8 weeks from treatment start) to last follow-up. Median follow-up at time of analysis among surviving patients was 5.0 years.
|
|
Testosterone Levels
Aikaikkuna: 3, 6, 9, and 12 months
|
Testosterone levels will be reported at this time points. |
3, 6, 9, and 12 months
|
|
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) Occurring Within 30 Days After the Completion of RT
Aikaikkuna: Up to 5 years
|
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values < 0.05. |
Up to 5 years
|
|
Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) Occurring More Thant 30 Days After the Completion of RT
Aikaikkuna: From the end of radiation therapy (approximately 7-8 weeks from treatment start) to two years.
|
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values < 0.05. |
From the end of radiation therapy (approximately 7-8 weeks from treatment start) to two years.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Felix Y Feng, NRG Oncology
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.
- Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Sukuelinten kasvaimet, mies
- Urogenitaaliset kasvaimet
- Neoplasmat sivustoittain
- Neoplasmat
- Sukuelinten sairaudet, mies
- Eturauhasen sairaudet
- Miesten urogenitaaliset sairaudet
- Eturauhasen kasvaimet
- Fyysiset ilmiöt
- Organisaatiot
- Terveydenhuollon taloustiede ja organisaatiot
- Säteily
- Kongressit aiheena
- apalutamidi
Muut tutkimustunnusnumerot
- NRG-GU006
- U10CA180868 (Yhdysvaltain NIH-apuraha/sopimus)
- NRG-GU006 (Muu tunniste: CTEP)
- NCI-2017-01268 (Rekisterin tunniste: CTRP (Clinical Trial Reporting Program))
- NRG-GU006 (Muu tunniste: NRG Oncology)
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IPD-suunnitelman kuvaus
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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