- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946213
Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation.
SECONDARY OBJECTIVES:
I. To compare physician-reported toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 between treatment arms.
II. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by Expanded Prostate Cancer Index Composite [EPIC]-26 urinary domains).
III. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain).
IV. To compare patient-reported fatigue (assessed by Patient Reported Outcomes Measurement Information System [PROMIS]-Fatigue) between treatment arms.
V. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity [COST]) between treatment arms.
VI. To compare failure-free survival between treatment arms. VII. To compare metastasis-free survival based on molecular imaging between treatment arms.
VIII. To compare overall survival between treatment arms.
EXPLORATORY OBJECTIVES:
I. To compare patient-reported sexual function (assessed by EPIC-26 sexual domain) between treatment arms.
II. To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between treatment arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo SBRT for a total of 5 treatments over 2 weeks.
ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 treatments over 4 to 9 weeks.
Patients are followed up every 6 months for 5 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Antioch, California, United States, 94531
- Recruiting
- Kaiser Permanente-Deer Valley Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Dublin, California, United States, 94568
- Recruiting
- Kaiser Permanente Dublin
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
-
Principal Investigator:
- Samantha A. Seaward
-
Fremont, California, United States, 94538
- Recruiting
- Kaiser Permanente-Fremont
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Fresno, California, United States, 93720
- Recruiting
- Kaiser Permanente-Fresno
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Fresno, California, United States, 93720
- Recruiting
- Fresno Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Modesto, California, United States, 95356
- Recruiting
- Kaiser Permanente-Modesto
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Oakland, California, United States, 94611
- Recruiting
- Kaiser Permanente-Oakland
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Oakland, California, United States, 94611
- Recruiting
- Kaiser Permanente Oakland-Broadway
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Orange, California, United States, 92868
- Recruiting
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
Principal Investigator:
- Steven N. Seyedin
-
Contact:
- Site Public Contact
- Phone Number: 877-827-8839
- Email: ucstudy@uci.edu
-
Rancho Cordova, California, United States, 95670
- Recruiting
- Kaiser Permanente-Rancho Cordova Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Redwood City, California, United States, 94063
- Recruiting
- Kaiser Permanente- Marshall Medical Offices
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
-
Principal Investigator:
- Samantha A. Seaward
-
Richmond, California, United States, 94801
- Recruiting
- Kaiser Permanente-Richmond
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Rohnert Park, California, United States, 94928
- Recruiting
- Rohnert Park Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Roseville, California, United States, 95661
- Recruiting
- Kaiser Permanente-Roseville
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
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Roseville, California, United States, 95678
- Recruiting
- The Permanente Medical Group-Roseville Radiation Oncology
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Sacramento, California, United States, 95814
- Recruiting
- Kaiser Permanente Downtown Commons
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Sacramento, California, United States, 95823
- Recruiting
- Kaiser Permanente-South Sacramento
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Sacramento, California, United States, 95823
- Recruiting
- South Sacramento Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
San Francisco, California, United States, 94115
- Recruiting
- Kaiser Permanente-San Francisco
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
San Jose, California, United States, 95119
- Recruiting
- Kaiser Permanente-Santa Teresa-San Jose
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
San Leandro, California, United States, 94577
- Recruiting
- Kaiser Permanente San Leandro
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
San Rafael, California, United States, 94903
- Recruiting
- Kaiser San Rafael-Gallinas
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Santa Clara, California, United States, 95051
- Recruiting
- Kaiser Permanente Medical Center - Santa Clara
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Santa Rosa, California, United States, 95403
- Recruiting
- Kaiser Permanente-Santa Rosa
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
South San Francisco, California, United States, 94080
- Recruiting
- Kaiser Permanente-South San Francisco
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
South San Francisco, California, United States, 94080
- Recruiting
- Kaiser Permanente Cancer Treatment Center
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Stockton, California, United States, 95210
- Recruiting
- Kaiser Permanente-Stockton
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Vacaville, California, United States, 95688
- Recruiting
- Kaiser Permanente Medical Center-Vacaville
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Vallejo, California, United States, 94589
- Recruiting
- Kaiser Permanente-Vallejo
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
Walnut Creek, California, United States, 94596
- Recruiting
- Kaiser Permanente-Walnut Creek
-
Contact:
- Site Public Contact
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Samantha A. Seaward
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Recruiting
- Helen F Graham Cancer Center
-
Principal Investigator:
- Gregory A. Masters
-
Contact:
- Site Public Contact
- Phone Number: 302-623-4450
- Email: lbarone@christianacare.org
-
Newark, Delaware, United States, 19713
- Recruiting
- Medical Oncology Hematology Consultants PA
-
Principal Investigator:
- Gregory A. Masters
-
Contact:
- Site Public Contact
- Phone Number: 302-623-4450
- Email: lbarone@christianacare.org
-
-
Florida
-
Jupiter, Florida, United States, 33458
- Recruiting
- Jupiter Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 561-745-5768
-
Principal Investigator:
- Nathan Tennyson
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1301
- Email: cancer@northwestern.edu
-
Principal Investigator:
- Sean Sachdev
-
DeKalb, Illinois, United States, 60115
- Recruiting
- Northwestern Medicine Cancer Center Kishwaukee
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Sean Sachdev
-
Decatur, Illinois, United States, 62526
- Recruiting
- Decatur Memorial Hospital
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Effingham, Illinois, United States, 62401
- Recruiting
- Crossroads Cancer Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Geneva, Illinois, United States, 60134
- Recruiting
- Northwestern Medicine Cancer Center Delnor
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Sean Sachdev
-
Shiloh, Illinois, United States, 62269
- Recruiting
- Memorial Hospital East
-
Contact:
- Site Public Contact
- Phone Number: 314-747-9912
- Email: dschwab@wustl.edu
-
Principal Investigator:
- Hiram A. Gay
-
Springfield, Illinois, United States, 62781
- Recruiting
- Memorial Medical Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-528-7541
- Email: pallante.beth@mhsil.com
-
Warrenville, Illinois, United States, 60555
- Recruiting
- Northwestern Medicine Cancer Center Warrenville
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Sean Sachdev
-
-
Iowa
-
Ames, Iowa, United States, 50010
- Recruiting
- McFarland Clinic - Ames
-
Principal Investigator:
- Joseph J. Merchant
-
Contact:
- Site Public Contact
- Phone Number: 515-239-4734
- Email: ksoder@mcfarlandclinic.com
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- Recruiting
- Saint Joseph Mercy Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Samir Narayan
-
Brighton, Michigan, United States, 48114
- Recruiting
- Saint Joseph Mercy Brighton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Samir Narayan
-
Canton, Michigan, United States, 48188
- Recruiting
- Saint Joseph Mercy Canton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Samir Narayan
-
Chelsea, Michigan, United States, 48118
- Recruiting
- Saint Joseph Mercy Chelsea
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Samir Narayan
-
Livonia, Michigan, United States, 48154
- Recruiting
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Samir Narayan
-
-
Minnesota
-
Duluth, Minnesota, United States, 55805
- Recruiting
- Saint Luke's Hospital of Duluth
-
Principal Investigator:
- Steven R. Bonin
-
Contact:
- Site Public Contact
- Phone Number: 218-249-7825
- Email: kdean@slhduluth.com
-
-
Missouri
-
Cape Girardeau, Missouri, United States, 63703
- Recruiting
- Saint Francis Medical Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 573-334-2230
- Email: sfmc@sfmc.net
-
Creve Coeur, Missouri, United States, 63141
- Recruiting
- Siteman Cancer Center at West County Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
-
Saint Louis, Missouri, United States, 63131
- Recruiting
- Missouri Baptist Medical Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 314-996-5569
-
Saint Louis, Missouri, United States, 63129
- Recruiting
- Siteman Cancer Center-South County
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
-
Saint Louis, Missouri, United States, 63136
- Recruiting
- Siteman Cancer Center at Christian Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
-
Saint Peters, Missouri, United States, 63376
- Recruiting
- Siteman Cancer Center at Saint Peters Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
-
-
Montana
-
Great Falls, Montana, United States, 59405
- Recruiting
- Benefis Healthcare- Sletten Cancer Institute
-
Principal Investigator:
- John M. Schallenkamp
-
Contact:
- Site Public Contact
- Phone Number: 406-969-6060
- Email: mccinfo@mtcancer.org
-
-
New York
-
Valhalla, New York, United States, 10595
- Recruiting
- Westchester Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 412-339-5294
- Email: Roster@nrgoncology.org
-
Principal Investigator:
- Mark D. Hurwitz
-
-
Ohio
-
Canton, Ohio, United States, 44710
- Recruiting
- Aultman Health Foundation
-
Principal Investigator:
- Steven E. Olyejar
-
Contact:
- Site Public Contact
- Phone Number: 330-363-7274
- Email: ClinicalReserachDept@aultman.com
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Tyler Gunter
-
-
Pennsylvania
-
Chadds Ford, Pennsylvania, United States, 19317
- Recruiting
- Christiana Care Health System-Concord Health Center
-
Principal Investigator:
- Gregory A. Masters
-
Contact:
- Site Public Contact
- Phone Number: 302-623-4450
- Email: lbarone@christianacare.org
-
West Reading, Pennsylvania, United States, 19611
- Recruiting
- Reading Hospital
-
Contact:
- Site Public Contact
- Phone Number: 610-988-9323
-
Principal Investigator:
- Michael L. Haas
-
-
Wisconsin
-
Antigo, Wisconsin, United States, 54409
- Recruiting
- Langlade Hospital and Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 715-623-9869
- Email: Juli.Alford@aspirus.org
-
Principal Investigator:
- Andrew J. Huang
-
Rhinelander, Wisconsin, United States, 54501
- Recruiting
- Ascension Saint Mary's Hospital
-
Principal Investigator:
- Andrew J. Huang
-
Contact:
- Site Public Contact
- Phone Number: 715-847-2353
- Email: Beth.Knetter@aspirus.org
-
Stevens Point, Wisconsin, United States, 54481
- Recruiting
- Ascension Saint Michael's Hospital
-
Principal Investigator:
- Andrew J. Huang
-
Contact:
- Site Public Contact
- Phone Number: 715-847-2353
- Email: Beth.Knetter@aspirus.org
-
Wausau, Wisconsin, United States, 54401
- Recruiting
- Aspirus Regional Cancer Center
-
Principal Investigator:
- Andrew J. Huang
-
Contact:
- Site Public Contact
- Phone Number: 877-405-6866
-
Wisconsin Rapids, Wisconsin, United States, 54494
- Recruiting
- Aspirus Cancer Care - Wisconsin Rapids
-
Principal Investigator:
- Andrew J. Huang
-
Contact:
- Site Public Contact
- Phone Number: 715-422-7718
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
High-risk disease defined as having at least one or more of the following:
- cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is not allowed
- The patient's prostate specific antigen (PSA) > 20 ng/mL prior to starting ADT Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
- Gleason Score of 8-10
- Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
- Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or computed tomography (CT) scan
- No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
- Age >= 18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- No prior radical prostatectomy
- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone [LHRH] agonist and oral anti-androgen) is =< 185 days prior to registration
- Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (SBRT)
Patients undergo SBRT for a total of 5 treatments over 2 weeks.
|
Undergo SBRT
Other Names:
|
Active Comparator: Arm II (EBRT)
Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks.
|
Undergo EBRT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metastasis-Free Survival (MFS)
Time Frame: From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
|
Based on conventional imaging.
MFS will be estimated using the Kaplan-Meier method (Kaplan 1958).
A confidence interval approach will be used adjusting for stratification factors.
If the one sided 95% upper confidence limit of HR < 1.35, then the null hypothesis of inferiority will be rejected.
If the 95% upper confidence limit excludes HR=1.35, then the null hypothesis of inferiority will be rejected.
Cox proportional hazards models will be used to obtain unadjusted and adjusted HRs and 95% confidence intervals for the treatment effects.
|
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure-Free Survival
Time Frame: From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
|
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.
Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, antiandrogen therapy (ADT) adherence, T stage, Gleason score, and performance status on outcomes.
|
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
|
Overall Survival
Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 15 years
|
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.
Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, ADT adherence, T stage, Gleason score, and performance status on outcomes.
|
From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 15 years
|
MFS
Time Frame: From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
|
Based on molecular imaging.
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test.
Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, ADT adherence, T stage, Gleason score, and performance status on outcomes.
|
From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years
|
Incidence of Adverse Events (AEs)
Time Frame: Up to 15 years
|
AEs will be graded using National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.
Counts of all AEs by grade will be provided by treatment arm.
|
Up to 15 years
|
Urinary Incontinence domain of the Expanded Prostate Cancer Index Composite (EPIC-26)
Time Frame: Up to 5 years
|
Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life.
|
Up to 5 years
|
Urinary Irritative/Obstructive domain of the Expanded Prostate Cancer Index Composite (EPIC-26)
Time Frame: Up to 5 years
|
Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life.
|
Up to 5 years
|
Bowel domain of the Expanded Prostate Cancer Index Composite (EPIC-26)
Time Frame: Up to 5 years
|
Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life.
|
Up to 5 years
|
Fatigue
Time Frame: Up to 5 years
|
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue.
Raw scores range from 7 to 35 and are standardized.
A higher score indicates more fatigue.
|
Up to 5 years
|
Cost
Time Frame: Up to 1 year
|
Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-COST.
|
Up to 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-reported outcomes
Time Frame: Up to 5 years
|
The EPIC-26 sexual domain will be assessed as an exploratory endpoint.
Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen E Hoffman, NRG Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRG-GU013 (Other Identifier: CTEP)
- U10CA180868 (U.S. NIH Grant/Contract)
- NCI-2023-04142 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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