Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
Purpose
This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
Conditions
- Stage III Prostate Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Criteria
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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm I (SBRT) |
Patients undergo SBRT for a total of 5 treatments over 2 weeks. |
|
|
Active Comparator Arm II (EBRT) |
Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks. |
|
Recruiting Locations
Antioch, California 94531
Dublin, California 94568
Site Public Contact
877-642-4691
Fremont, California 94538
Fresno, California 93720
Fresno, California 93720
Modesto, California 95356
Oakland, California 94611
Oakland, California 94611
Orange, California 92868
Rancho Cordova, California 95670
Redwood City, California 94063
Site Public Contact
877-642-4691
Richmond, California 94801
Rohnert Park, California 94928
Roseville, California 95661
Roseville, California 95678
Sacramento, California 95814
Sacramento, California 95823
Sacramento, California 95823
San Francisco, California 94115
San Jose, California 95119
San Leandro, California 94577
San Rafael, California 94903
Santa Clara, California 95051
Santa Rosa, California 95403
South San Francisco, California 94080
South San Francisco, California 94080
Stockton, California 95210
Vacaville, California 95688
Vallejo, California 94589
Walnut Creek, California 94596
Newark, Delaware 19713
Newark, Delaware 19713
Jupiter, Florida 33458
Site Public Contact
561-745-5768
Chicago, Illinois 60611
Decatur, Illinois 62526
DeKalb, Illinois 60115
Effingham, Illinois 62401
Geneva, Illinois 60134
Shiloh, Illinois 62269
Springfield, Illinois 62781
Warrenville, Illinois 60555
Ames, Iowa 50010
Ann Arbor, Michigan 48106
Brighton, Michigan 48114
Canton, Michigan 48188
Chelsea, Michigan 48118
Livonia, Michigan 48154
Duluth, Minnesota 55805
Cape Girardeau, Missouri 63703
Creve Coeur, Missouri 63141
Saint Louis, Missouri 63110
Saint Louis, Missouri 63129
Saint Louis, Missouri 63131
Site Public Contact
314-996-5569
Saint Louis, Missouri 63136
Saint Peters, Missouri 63376
Great Falls, Montana 59405
Valhalla, New York 10595
Canton, Ohio 44710
Oklahoma City, Oklahoma 73104
Chadds Ford, Pennsylvania 19317
West Reading, Pennsylvania 19611
Site Public Contact
610-988-9323
Antigo, Wisconsin 54409
Rhinelander, Wisconsin 54501
Stevens Point, Wisconsin 54481
Wausau, Wisconsin 54401
Site Public Contact
877-405-6866
Wisconsin Rapids, Wisconsin 54494
Site Public Contact
715-422-7718
More Details
- NCT ID
- NCT05946213
- Status
- Recruiting
- Sponsor
- NRG Oncology
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.