Androgen Suppression with Radiation for Prostate Cancer
This study is comparing two ways to treat prostate cancer: a standard approach using external beam radiation therapy (EBRT) with a brachytherapy boost (radiation sources placed directly in the prostate), and a newer approach called Stereotactic Body Radiation Therapy (SBRT). Both methods are combined with hormone therapy (androgen deprivation therapy or ADT). The study wants to see if SBRT, which delivers higher radiation doses in fewer treatments, is as effective as the standard treatment. You may be able to join if you are a man, 18 or older, with prostate cancer that has been confirmed by a biopsy within the last 9 months and is classified as unfavorable-intermediate or high/very high risk. The main goal is to see how long people live without their cancer progressing, measured over about 8.6 years. The current enrollment status is unclear.
- Study design
- This interventional study plans to enroll 710 men with prostate cancer to compare different radiation and hormone therapy combinations.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for about 8.6 years to see how long they live without their cancer progressing.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06235697
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
Recruiting
PHASE3Ages 18+InterventionalTreatmentCanadian Cancer Trials GroupGovernment-funded
~710 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:RadiationRadiation SBRT onlyADT
At a glance
Recruiting sites
57 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare the progression-free survival (PFS) of SBRT versus conventional EBRT plus brachytherapy boost defined as time to biochemical failure, initiation of salvage therapy, local-regional recurrence, distant progression, or death
Measured over 8.6 years
Conditions
Where it's being run
57 sites across 10 statesCalifornia27
Ontario8
Pennsylvania6
Missouri5
New York3
Virginia3
Quebec2
Illinois1
Study leadership
- Andrew Loblaw · STUDY_CHAIR · Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months
Participants with unfavourable risk prostate cancer are eligible according to the following NCCN classification guidelines (Version 4.2022 - May 10, 2022):
2 or 3 Intermediate Risk Factors (IRFs): cT2b-cT2c, Gleason 7 (grade group 2 or 3), and/or PSA 10-20 ng/ml;
Gleason 4+3 (grade group 3)
\> 50% biopsy cores positive
cT3a
Gleason 8-10 (grade group 4 or 5)
PSA \> 20 ng/ml
cT3b-cT4
Primary Gleason pattern 5
2 or 3 high risk features: cT3a, Gleason 8-10 (grade group 4 or 5), and/or PSA \> 20 ng/ml
\> 4 cores with Gleason 8-10 (grade group 4 or 5)
ECOG performance status of 0, 1 or 2
Participants must be ≥ 18 years of age
Judged to be medically fit for brachytherapy
Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French or Spanish
Participants consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate
Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of participant enrollment
Participants must be willing to take precautions to prevent pregnancy while on study
ADT (LHRH agonists, antagonists, or anti-androgens) for prostate cancer is permitted for up to 30 days before study enrollment
5-alpha reductase inhibitors (5-ARI) are allowed, but baseline PSA will be corrected if 5-ARI use occurs within 6 months of enrollment
Participants may NOT have received other therapies including chemotherapy, PARPi, radioligand or other investigational drugs for prostate cancer
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Urinary function defined as International Prostate Symptom Score (IPSS) \< 20. Alpha blockers are allowed to treat baseline urinary function
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Exclusion
Prior pelvic radiotherapy
Contraindication to radical prostate radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
Anticoagulation medication (if unsafe to discontinue for gold seed insertion or brachytherapy implant) and/or prior or current bleeding diathesis
Prior steam vaporization (Rezum), transurethral resection of the prostate (TURP), prostatectomy (simple or radical), or any ablative therapy to the prostate (cryotherapy, HIFU, TULSA, focal laser ablation, photodynamic therapy)
Prostate volume \> 60cc before start of androgen deprivation therapy
Anatomy that would preclude precise brachytherapy implant (such as arch interference or large median lobe)
Evidence of castrate resistance (defined as a rising PSA \> 3.0 ng/ml while testosterone is \< 3.0 nmol/l)
Hip prosthesis (unilateral hip replacement is allowed if dose constrains can be reasonably achieved.
What this trial measures
- To compare the progression-free survival (PFS) of SBRT versus conventional EBRT plus brachytherapy boost defined as time to biochemical failure, initiation of salvage therapy, local-regional recurrence, distant progression, or death8.6 years