Actively Recruiting
Androgen Suppression Combined With Elective Nodal Irradiation and Dose Escalated Prostate Treatment: A Non-Inferiority, Phase III Randomized Controlled Trial of Stereotactic Body Radiation Therapy Versus Brachytherapy Boost in Patients With Unfavourable Risk Localized Prostate Cancer
Led by Canadian Cancer Trials Group · Updated on 2026-04-14
710
Participants Needed
57
Research Sites
25 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
N
NRG Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial investigates treatment options for men with unfavourable risk localized prostate cancer. Researchers are comparing a newer radiation method called Stereotactic Body Radiation Therapy (SBRT), which uses higher doses over fewer sessions with special equipment, against the standard external beam radiation combined with a brachytherapy boost. The study aims to find out if SBRT is as effective as the standard approach in controlling prostate cancer progression. Participants will receive either the standard treatment involving external beam radiation to the pelvis and prostate plus a brachytherapy boost, combined with hormone therapy, or the experimental SBRT treatment delivering higher radiation doses in fewer sessions. Adjuvant androgen deprivation therapy (ADT) will be given according to risk level, lasting 6 months for intermediate risk and 24 months for high or very high risk. Treatments are assigned randomly to compare outcomes between groups. Throughout the study, participants will be monitored for cancer progression, side effects, and quality of life using questionnaires and medical assessments for up to 8.6 years. Researchers will track progression-free survival, PSA response, metastasis-free survival, and overall survival, as well as participant-reported tolerability and economic outcomes. Safety will be assessed continuously to understand how well participants tolerate the treatments over time.
CONDITIONS
Brief Title
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months
- Unfavourable risk prostate cancer as defined by NCCN guidelines including unfavourable intermediate, high, or very-high risk categories
- ECOG performance status of 0, 1, or 2
- Age 18 years or older
- Medically fit for brachytherapy
- Able and willing to complete quality of life questionnaires in English, French, or Spanish
- Signed informed consent prior to enrollment
- Accessible for treatment and follow-up with availability for complete documentation
- Protocol treatment to begin within 12 weeks of enrollment
- Willing to take precautions to prevent pregnancy while on study
- ADT allowed up to 30 days before enrollment
- 5-alpha reductase inhibitors allowed with PSA correction if used within 6 months
- No prior chemotherapy, PARPi, radioligand, or investigational drugs for prostate cancer
- Prior or concurrent malignancies allowed if not interfering with study assessment
- Urinary function with IPSS less than 20; alpha blockers allowed
- HIV-infected patients on effective therapy with undetectable viral load within 6 months
You will not qualify if you...
- Prior pelvic radiotherapy
- Contraindications to radical prostate radiotherapy such as connective tissue or inflammatory bowel disease
- Use of anticoagulation medication unsafe to discontinue for brachytherapy or bleeding disorders
- Prior prostate surgeries or ablative therapies including Rezum, TURP, prostatectomy, cryotherapy, HIFU, TULSA, focal laser ablation, or photodynamic therapy
- Prostate volume greater than 60cc before androgen deprivation therapy
- Anatomy preventing precise brachytherapy implant such as arch interference or large median lobe
- Evidence of castrate resistance defined by rising PSA above 3.0 ng/ml with low testosterone
- Presence of hip prosthesis unless dose constraints can be reasonably achieved
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months depending on hormone therapy duration
Participants receive androgen deprivation therapy combined with radiation therapy. Radiation may include external beam radiation therapy (EBRT) to the pelvis and prostate with a brachytherapy boost or stereotactic body radiation therapy (SBRT). Adjuvant hormone therapy duration varies based on risk category.
Multiple visits during radiation treatment and hormone therapy as per schedule
Duration - Up to 8.6 years
Participants are monitored for treatment effectiveness and side effects through long-term assessments including survival, cancer progression, and quality of life.
Periodic visits scheduled over several years for monitoring and questionnaires
Trial Site Locations
Total: 57 locations
1
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
Actively Recruiting
2
Kaiser Permanente Dublin
Dublin, California, United States, 94568
Actively Recruiting
3
Kaiser Permanente-Fremont
Fremont, California, United States, 94538
Actively Recruiting
4
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States, 93720
Actively Recruiting
5
Kaiser Permanente-Fresno
Fresno, California, United States, 93720
Actively Recruiting
6
Kaiser Permanente-Modesto
Modesto, California, United States, 95356
Actively Recruiting
7
Kaiser Permanente Oakland-Broadway
Oakland, California, United States, 94611
Actively Recruiting
8
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
9
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, United States, 94063
Actively Recruiting
10
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Actively Recruiting
11
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
Actively Recruiting
12
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Actively Recruiting
13
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States, 95678
Actively Recruiting
14
Kaiser Permanente Downtown Commons
Sacramento, California, United States, 95814
Actively Recruiting
15
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
Actively Recruiting
16
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
17
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Actively Recruiting
18
Kaiser Permanente San Leandro
San Leandro, California, United States, 94577
Actively Recruiting
19
Kaiser San Rafael-Gallinas
San Rafael, California, United States, 94903
Actively Recruiting
20
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Actively Recruiting
21
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Actively Recruiting
22
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States, 94080
Actively Recruiting
23
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Actively Recruiting
24
Kaiser Permanente-Stockton
Stockton, California, United States, 95210
Actively Recruiting
25
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States, 95688
Actively Recruiting
26
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Actively Recruiting
27
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
Actively Recruiting
28
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
29
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
30
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
31
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
32
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
33
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
34
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
35
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States, 11042
Actively Recruiting
36
Manhattan Eye Ear and Throat Hospital
New York, New York, United States, 10065
Actively Recruiting
37
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
38
Saint Vincent Hospital
Erie, Pennsylvania, United States, 16544
Actively Recruiting
39
Jefferson Hospital
Jefferson Hills, Pennsylvania, United States, 15025
Actively Recruiting
40
Forbes Hospital
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
41
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
42
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
43
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
44
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States, 23114
Actively Recruiting
45
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, United States, 23230
Actively Recruiting
46
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
47
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
48
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Actively Recruiting
49
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
50
Waterloo Regional Health Network
Kitchener, Ontario, Canada, N2G 1G3
Actively Recruiting
51
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Actively Recruiting
52
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Actively Recruiting
53
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Actively Recruiting
54
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
55
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
56
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
57
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
Research Team
W
Wendy Parulekar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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