Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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)?
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * 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 * 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 Criteria: * 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.
Study sites (46)
CA
- Kaiser Permanente-Deer Valley Medical Center · Antioch, CA 94531Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Antioch
- Kaiser Permanente Dublin · Dublin, CA 94568Site Public Contact · Study contact · 877-642-4691Samantha A. Seaward · Principal investigatorMore trials in Dublin
- Kaiser Permanente-Fremont · Fremont, CA 94538Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Fremont
- Kaiser Permanente Fresno Orchard Plaza · Fresno, CA 93720Site Public Contact · Study contact · 833-574-2273Samantha A. Seaward · Principal investigatorMore trials in Fresno
- Kaiser Permanente-Fresno · Fresno, CA 93720Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Fresno
- Kaiser Permanente-Modesto · Modesto, CA 95356Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Modesto
- Kaiser Permanente Oakland-Broadway · Oakland, CA 94611Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Oakland
- Kaiser Permanente-Oakland · Oakland, CA 94611Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Oakland
- Kaiser Permanente- Marshall Medical Offices · Redwood City, CA 94063Site Public Contact · Study contact · 877-642-4691Samantha A. Seaward · Principal investigatorMore trials in Redwood City
- Kaiser Permanente-Richmond · Richmond, CA 94801Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Richmond
- Rohnert Park Cancer Center · Rohnert Park, CA 94928Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Rohnert Park
- Kaiser Permanente-Roseville · Roseville, CA 95661Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Roseville
- The Permanente Medical Group-Roseville Radiation Oncology · Roseville, CA 95678Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Roseville
- Kaiser Permanente Downtown Commons · Sacramento, CA 95814Site Public Contact · Study contact · 877-642-4691 · kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Sacramento
- Kaiser Permanente-South Sacramento · Sacramento, CA 95823Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Sacramento
- Kaiser Permanente-San Francisco · San Francisco, CA 94115Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in San Francisco
- Kaiser Permanente-Santa Teresa-San Jose · San Jose, CA 95119Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in San Jose
- Kaiser Permanente San Leandro · San Leandro, CA 94577Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in San Leandro
- Kaiser San Rafael-Gallinas · San Rafael, CA 94903Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in San Rafael
- Kaiser Permanente Medical Center - Santa Clara · Santa Clara, CA 95051Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Santa Clara
- Kaiser Permanente-Santa Rosa · Santa Rosa, CA 95403Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Santa Rosa
- Kaiser Permanente Cancer Treatment Center · South San Francisco, CA 94080Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in South San Francisco
- Kaiser Permanente-South San Francisco · South San Francisco, CA 94080Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in South San Francisco
- Kaiser Permanente-Stockton · Stockton, CA 95210Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Stockton
- Kaiser Permanente Medical Center-Vacaville · Vacaville, CA 95688Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Vacaville
- Kaiser Permanente-Vallejo · Vallejo, CA 94589Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Vallejo
- Kaiser Permanente-Walnut Creek · Walnut Creek, CA 94596Site Public Contact · Study contact · 877-642-4691 · Kpoct@kp.orgSamantha A. Seaward · Principal investigatorMore trials in Walnut Creek
IL
- Memorial Hospital East · Shiloh, IL 62269Site Public Contact · Study contact · 314-747-9912 · dschwab@wustl.eduLannis E. Hall · Principal investigatorMore trials in Shiloh
MO
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, MO 63376Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduLannis E. Hall · Principal investigatorMore trials in City of Saint Peters
- Siteman Cancer Center at West County Hospital · Creve Coeur, MO 63141Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduLannis E. Hall · Principal investigatorMore trials in Creve Coeur
- Washington University School of Medicine · St Louis, MO 63110Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduLannis E. Hall · Principal investigatorMore trials in St Louis
- Siteman Cancer Center-South County · St Louis, MO 63129Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduLannis E. Hall · Principal investigatorMore trials in St Louis
- Siteman Cancer Center at Christian Hospital · St Louis, MO 63136Site Public Contact · Study contact · 800-600-3606 · info@siteman.wustl.eduLannis E. Hall · Principal investigatorMore trials in St Louis
MT
- Billings Clinic Cancer Center · Billings, MT 59101Site Public Contact · Study contact · 800-996-2663 · research@billingsclinic.orgJohn M. Schallenkamp · Principal investigatorMore trials in Billings
NY
- Northwell Health/Center for Advanced Medicine · Lake Success, NY 11042Site Public Contact · Study contact · 516-734-8896Sang E. Sim · Principal investigatorMore trials in Lake Success
- Manhattan Eye Ear and Throat Hospital · New York, NY 10065Site Public Contact · Study contact · 212-434-4460Sang E. Sim · Principal investigatorMore trials in New York
- Lenox Hill Hospital · New York, NY 10075Site Public Contact · Study contact · 516-734-8896Sang E. Sim · Principal investigatorMore trials in New York
PA
- Saint Vincent Hospital · Erie, PA 16544Site Public Contact · Study contact · 814-452-5000Zachary Horne · Principal investigatorMore trials in Erie
- Jefferson Hospital · Jefferson Hills, PA 15025Site Public Contact · Study contact · 412-359-3043 · ddefazio@wpahs.orgZachary Horne · Principal investigatorMore trials in Jefferson Hills
- Forbes Hospital · Monroeville, PA 15146Site Public Contact · Study contact · 412-858-7746Zachary Horne · Principal investigatorMore trials in Monroeville
- Allegheny General Hospital · Pittsburgh, PA 15212Site Public Contact · Study contact · 877-284-2000Zachary Horne · Principal investigatorMore trials in Pittsburgh
- West Penn Hospital · Pittsburgh, PA 15224Site Public Contact · Study contact · 412-578-5000Zachary Horne · Principal investigatorMore trials in Pittsburgh
- Wexford Health and Wellness Pavilion · Wexford, PA 15090Site Public Contact · Study contact · Dawnmarie.DeFazio@ahn.orgZachary Horne · Principal investigatorMore trials in Wexford
VA
- Bon Secours Saint Francis Medical Center · Midlothian, VA 23114Site Public Contact · Study contact · 804-893-8978 · anne_carmellat@bshsi.orgJoseph D. Pennington · Principal investigatorMore trials in Midlothian
- Bon Secours Cancer Institute at Reynolds Crossing · Richmond, VA 23230Site Public Contact · Study contact · 804-893-8978 · Anne_caramella@bshsi.orgJoseph D. Pennington · Principal investigatorMore trials in Richmond
- VCU Massey Comprehensive Cancer Center · Richmond, VA 23298Site Public Contact · Study contact · 804-628-6430 · CTOclinops@vcu.eduAlfredo I. Urdaneta · Principal investigatorMore trials in Richmond