Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

What this study is about

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)?

Who can join (things the study team will check)

✅ You may be able to join 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

+ 6 more criteria — see the full checklist in the app.

🚫 You may not be able to join 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 this trial is running

• Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States
• Kaiser Permanente Dublin, Dublin, California, United States
• Kaiser Permanente-Fremont, Fremont, California, United States
• Kaiser Permanente Fresno Orchard Plaza, Fresno, California, United States
• Kaiser Permanente-Fresno, Fresno, California, United States
• Kaiser Permanente-Modesto, Modesto, California, United States
• Kaiser Permanente Oakland-Broadway, Oakland, California, United States
• Kaiser Permanente-Oakland, Oakland, California, United States
• Kaiser Permanente- Marshall Medical Offices, Redwood City, California, United States
• Kaiser Permanente-Richmond, Richmond, California, United States
• Rohnert Park Cancer Center, Rohnert Park, California, United States
• Kaiser Permanente-Roseville, Roseville, California, United States

+ 45 more sites.

Who to contact

Wendy Parulekar · 613-533-6430 · wparulekar@ctg.queensu.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06235697.