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Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy

23 oktober 2017 bijgewerkt door: Radiation Therapy Oncology Group

A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

OBJECTIVES:

Primary

  • Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus vitamin D and calcium supplement vs standard therapy with vitamin D and calcium supplement in the prevention of osteoporosis and associated bone fractures in patients with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing radiotherapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy.

Secondary

  • Evaluate the potential benefit of these regimens on quality of life in these patients.
  • Evaluate the potential benefit in bone mineral density over a period of 3 years for patients treated with these regimens.

OUTLINE: This is randomized multicenter study. Patients are stratified according to T score of the hip by dual x-ray absorptiometry (DXA) scan (< -1.0 but > -2.5 vs ≥ - 1.0) and planned duration of luteinizing hormone-releasing hormone (LHRH) agonist therapy (1-2½ years vs > 2½ years). Patients are randomized to 1 of 2 treatment arms.

Quality of life is assessed at baseline and every 6 months during treatment.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

109

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Centre
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Cancer Care Program at Thunder Bay Regional Health Sciences
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Quebec City, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
  • Verenigde Staten
    • California
      • Chico, California, Verenigde Staten, 95926
        • Enloe Cancer Center at Enloe Medical Center
      • Los Angeles, California, Verenigde Staten, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Pomona, California, Verenigde Staten, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Roseville, California, Verenigde Staten, 95661
        • Radiation Oncology Center - Roseville
      • Sacramento, California, Verenigde Staten, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
    • Colorado
      • Colorado Springs, Colorado, Verenigde Staten, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Pueblo, Colorado, Verenigde Staten, 81004
        • St. Mary - Corwin Regional Medical Center
    • Georgia
      • Gainesville, Georgia, Verenigde Staten, 30501
        • Northeast Georgia Medical Center
    • Illinois
      • Alton, Illinois, Verenigde Staten, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Arlington Heights, Illinois, Verenigde Staten, 60005
        • Northwest Community Hospital
      • Harvey, Illinois, Verenigde Staten, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Olympia Fields, Illinois, Verenigde Staten, 60461
        • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
      • Urbana, Illinois, Verenigde Staten, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Goshen, Indiana, Verenigde Staten, 46526
        • Center for Cancer Care at Goshen General Hospital
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Methodist Cancer Center at Methodist Hospital
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, Verenigde Staten, 21229
        • St. Agnes Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, Verenigde Staten, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Kalamazoo, Michigan, Verenigde Staten, 49007-3731
        • West Michigan Cancer Center
    • Minnesota
      • Saint Cloud, Minnesota, Verenigde Staten, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Verenigde Staten, 56303
        • Coborn Cancer Center
    • Missouri
      • Cape Girardeau, Missouri, Verenigde Staten, 63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Kansas City, Missouri, Verenigde Staten, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Verenigde Staten, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, Verenigde Staten, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Saint Louis, Missouri, Verenigde Staten, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Springfield, Missouri, Verenigde Staten, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Verenigde Staten, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Verenigde Staten, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Verenigde Staten, 59101
        • Northern Rockies Radiation Oncology Center
      • Great Falls, Montana, Verenigde Staten, 59405
        • Great Falls Clinic - Main Facility
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89106
        • CCOP - Nevada Cancer Research Foundation
      • Reno, Nevada, Verenigde Staten, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Keene, New Hampshire, Verenigde Staten, 03431
        • Kingsbury Center for Cancer Care at Cheshire Medical Center
      • Lebanon, New Hampshire, Verenigde Staten, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, Verenigde Staten, 08103
        • Cancer Institute of New Jersey at Cooper University Hospital - Camden
      • Vineland, New Jersey, Verenigde Staten, 08360
        • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
      • Voorhees, New Jersey, Verenigde Staten, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Binghamton, New York, Verenigde Staten, 13905
        • Lourdes Regional Cancer Center
      • Brooklyn, New York, Verenigde Staten, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • Buffalo, New York, Verenigde Staten, 14263-0001
        • Roswell Park Cancer Institute
      • East Syracuse, New York, Verenigde Staten, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Asheville, North Carolina, Verenigde Staten, 28801
        • Mission Hospitals - Memorial Campus
      • Goldsboro, North Carolina, Verenigde Staten, 27534
        • Wayne Radiation Oncology
      • Raleigh, North Carolina, Verenigde Staten, 27607
        • Cancer Centers of North Carolina - Raleigh
      • Wilson, North Carolina, Verenigde Staten, 27893
        • Wilmed Radiation Oncology Services
    • Ohio
      • Akron, Ohio, Verenigde Staten, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Akron, Ohio, Verenigde Staten, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Cincinnati, Ohio, Verenigde Staten, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Salem, Ohio, Verenigde Staten, 44460
        • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
      • West Chester, Ohio, Verenigde Staten, 45069
        • Precision Radiotherapy at University Pointe
      • Wooster, Ohio, Verenigde Staten, 44691
        • Cancer Treatment Center
    • Pennsylvania
      • Abington, Pennsylvania, Verenigde Staten, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, Verenigde Staten, 19010
        • Bryn Mawr Hospital
      • Gettysburg, Pennsylvania, Verenigde Staten, 17325
        • Adams Cancer Center
      • Paoli, Pennsylvania, Verenigde Staten, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Verenigde Staten, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Wynnewood, Pennsylvania, Verenigde Staten, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • York, Pennsylvania, Verenigde Staten, 17405
        • York Cancer Center at Apple Hill Medical Center
    • Tennessee
      • Kingsport, Tennessee, Verenigde Staten, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • Utah
      • Murray, Utah, Verenigde Staten, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, Verenigde Staten, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, Verenigde Staten, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Verenigde Staten, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Verenigde Staten, 84143
        • LDS Hospital
    • Vermont
      • Saint Johnsbury, Vermont, Verenigde Staten, 05819
        • Norris Cotton Cancer Center - North
    • Virginia
      • Norfolk, Virginia, Verenigde Staten, 23507
        • Sentara Cancer Institute at Sentara Norfolk General Hospital
      • Portsmouth, Virginia, Verenigde Staten, 23708-2197
        • Naval Medical Center - Portsmouth
    • Washington
      • Yakima, Washington, Verenigde Staten, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Wisconsin
      • Appleton, Wisconsin, Verenigde Staten, 54911
        • Theda Care Cancer Institute
      • Green Bay, Wisconsin, Verenigde Staten, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Marinette, Wisconsin, Verenigde Staten, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Menomonee Falls, Wisconsin, Verenigde Staten, 53051
        • Community Memorial Hospital Cancer Care Center
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, Verenigde Staten, 53295
        • Veterans Affairs Medical Center - Milwaukee
      • Milwaukee, Wisconsin, Verenigde Staten, 53215
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
      • West Allis, Wisconsin, Verenigde Staten, 53227
        • West Allis Memorial Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Eligibility criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 12 months of registration;

  • Any one of the following clinical stages:

    • T3 disease, any N stage, M0 with any Gleason score and any prostate-specific antigen (PSA); < T3 stage, any N stage, M0 with Gleason's score ≥ 8 and any PSA; < T3 stage, any N stage, M0 with Gleason's score 7 and PSA ≥ 15 nanograms/ml; < T3 stage, any N stage, M0 with Gleason score < 7 and PSA ≥ 20 nanograms/ml.
  • A negative bone scan for metastatic disease;
  • It is mandatory that the treating physician determine the planned duration of LHRH therapy prior to the site registering the patient (minimum 1 year of therapy); If patient is receiving pre-treatment LHRH therapy, it must have begun ≤ 6 months prior to registration. If pelvic radiation therapy (RT) has started, it must have begun ≤ 8 weeks prior to registration;
  • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup to be done within 16 weeks prior to registration:
  • History/physical examination;
  • Dental evaluation, including history of dental surgery (e.g., extraction or implant);
  • Bone scan;
  • T and L spine films;
  • DXA scan: To be eligible the patient must have a scan on Lunar, Hologic, or Norland equipment only and the T scores in both the L spine and total hip must be > negative 2.5;
  • Zubrod Performance Status 0-1 within 16 weeks prior to registration; (8/16/07)
  • Age ≥ 18;
  • Serum creatinine within 4 weeks prior to registration (8/16/07)
  • Corrected serum calcium ≥ 8.4 and ≤ 10.6 mg/dl within 8 weeks prior to registration; note: for patients with an albumin of 4.0, corrected calcium=measured calcium. The formula for corrected calcium if serum albumin value is above or below 4.0 is as follows: Corrected calcium (mg/dl) = (4 - [patient's albumin (g/dl)] x 0.8) + patient's measured calcium (mg/dl)
  • Patients who are sexually active must be willing/able to use medically acceptable forms of contraception, as the treatment involved in this study may be significantly teratogenic.
  • Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy";
  • Post-prostatectomy patients are eligible.
  • Patient must sign study specific informed consent prior to study entry.

Ineligibility criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; e.g., carcinoma in situ of the breast or oral cavity are permissible;
  • Patients with baseline T scores of ≤ -2.5 are excluded.
  • Patients with baseline calculated creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault formula below) are excluded. creatinine clearance male = [(140 - age) x (wt in kg)] / [(serum creatinine) x (72)]
  • Prior bisphosphonate therapy;
  • Prior pelvic radiation (other than for current prostate cancer) or prior systemic radiotherapeutic agents, such as strontium or samarium;
  • Patients receiving systemic chemotherapy, steroids, growth hormones, or calcitonin;
  • Patients with a history of Paget's disease or with uncontrolled thyroid or parathyroid dysfunction or with other diseases that influence bone metabolism;
  • Known hypersensitivity to zoledronic acid or other bisphosphonates;
  • Active dental problems at study entry, including infection of the teeth or jawbone; dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures;
  • Recent or planned

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Zoledronic Acid
Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Voedingssupplement: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Voedingssupplement: Zoledronic acid
Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.
Andere namen:
  • Zometa
  • zoledronaat
Straling: radiation therapy
Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
Geneesmiddel: LHRH
LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
Voedingssupplement: Vitamin D
400 IU (10μg), orally each day for 3 years.
Actieve vergelijker: Control
Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Voedingssupplement: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Straling: radiation therapy
Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.
Geneesmiddel: LHRH
LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.
Voedingssupplement: Vitamin D
400 IU (10μg), orally each day for 3 years.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Freedom From Any Bone Fracture (FABF) Rate at Three Years
Tijdsspanne: From randomization to 3 years
The time of failure was measured from the date of randomization to the date of documented bone fractures, defined as any fracture of the bone. The three-year FABF rate will be estimated by the Kaplan-Meier method.
From randomization to 3 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Change in Bone Mineral Density at 3 Years
Tijdsspanne: Baseline, 3 years from start of treatment
Bone mineral density (BMD) was measured by DXA scan (Dual X-ray absorptiometry) for five locations: lumbar, right total hip, left total hip, right femoral neck, and left femoral neck. The percent change at 3 years was calculated for each location by the following formula: Percent Change BMD = (BMD_3 years - BMD_Baseline)/ BMD_Baseline * 100.
Baseline, 3 years from start of treatment
Changes in the Functional Assessment of Cancer Therapy-General (FACT-G) at 3 Years
Tijdsspanne: Baseline, 3 years from start of treatment
The FACT-G is a validated, 27-item measure. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for the physical, social and functional subscales, and 0-24 for the emotional subscale. Certain items, identified on the FACT-G scoring guides, must be reversed before it is added by subtracting the response from 4. All subscale totals are added together to form the FACT-G total score. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicates better QOL.
Baseline, 3 years from start of treatment
Utility of the Use of Bisphosphonates as Assessed by Quality-adjusted Survival
Tijdsspanne: From pre-treatment to 3 years from start of treatment
The EQ-5D is a standardized instrument for measuring generic health status used to generate health utilities, used to derive quality adjusted survival. Quality adjusted survival is computed using the weighted sum of times in different health states added up to a total quality-adjusted survival time. The log-rank test is used to compare quality-adjusted survivals between the treatment arms.
From pre-treatment to 3 years from start of treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Radiation Therapy Oncology Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Colleen A. Lawton, MD, Medical College of Wisconsin
  • Studie stoel: Matthew R. Smith, MD, Massachusetts General Hospital
  • Studie stoel: Margaret Chamberlain-Wilmoth, PhD, MSS, RN, Carolinas Medical Center - University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2006

Primaire voltooiing (Werkelijk)

1 november 2014

Studie voltooiing (Werkelijk)

1 november 2014

Studieregistratiedata

Eerst ingediend

23 mei 2006

Eerst ingediend dat voldeed aan de QC-criteria

23 mei 2006

Eerst geplaatst (Schatting)

25 mei 2006

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 november 2017

Laatste update ingediend die voldeed aan QC-criteria

23 oktober 2017

Laatst geverifieerd

1 oktober 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RTOG 0518
  • CDR0000476469
  • NCI-2009-00884 (Register-ID: CTRP (Clinical Trial Reporting Program))

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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