Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

Recruiting now · Phase 3

Conditions studied: Prostate Cancer

In brief

This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?

Key facts

Study ID: NCT06235697
Run by: Canadian Cancer Trials Group
People needed: 710
Starts: 2024-04-25
Expected to finish: 2033-04-30
Last updated by the study team: 2026-04-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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):
Unfavourable-intermediate risk - has one or more of the following:
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
High risk - has one of the following:
cT3a
Gleason 8-10 (grade group 4 or 5)
PSA > 20 ng/ml
Very-high risk - has at least one of the following:
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

You may not qualify if…

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.

Where it is running

Kaiser Permanente Dublin — Dublin, California, United States (enrolling)
Kaiser Permanente-Fremont — Fremont, California, United States (enrolling)
Kaiser Permanente Fresno Orchard Plaza — Fresno, California, United States (enrolling)
Kaiser Permanente-Fresno — Fresno, California, United States (enrolling)
Kaiser Permanente-Modesto — Modesto, California, United States (enrolling)
Kaiser Permanente Oakland-Broadway — Oakland, California, United States (enrolling)
Kaiser Permanente-Oakland — Oakland, California, United States (enrolling)
Kaiser Permanente- Marshall Medical Offices — Redwood City, California, United States (enrolling)
Kaiser Permanente-Richmond — Richmond, California, United States (enrolling)
Rohnert Park Cancer Center — Rohnert Park, California, United States (enrolling)
Kaiser Permanente-Roseville — Roseville, California, United States (enrolling)
The Permanente Medical Group-Roseville Radiation Oncology — Roseville, California, United States (enrolling)
Kaiser Permanente Downtown Commons — Sacramento, California, United States (enrolling)
Kaiser Permanente-South Sacramento — Sacramento, California, United States (enrolling)
Kaiser Permanente-San Francisco — San Francisco, California, United States (enrolling)
Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States (enrolling)
Kaiser Permanente San Leandro — San Leandro, California, United States (enrolling)
Kaiser San Rafael-Gallinas — San Rafael, California, United States (enrolling)
Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States (enrolling)
Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States (enrolling)
Kaiser Permanente Cancer Treatment Center — South San Francisco, California, United States (enrolling)
Kaiser Permanente-South San Francisco — South San Francisco, California, United States (enrolling)
Kaiser Permanente-Stockton — Stockton, California, United States (enrolling)
Kaiser Permanente Medical Center-Vacaville — Vacaville, California, United States (enrolling)
Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States (enrolling)

Full record on ClinicalTrials.gov

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