Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
Recruiting · NCT06235697 · Interventional (participants receive a specific treatment) · Lead sponsor: Canadian Cancer Trials Group
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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 take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
57 locations listed across 7 US states.
- 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
- The Permanente Medical Group-Roseville Radiation Oncology - Roseville, California, United States
- Kaiser Permanente Downtown Commons - Sacramento, California, United States
- Kaiser Permanente-South Sacramento - Sacramento, California, United States
- Kaiser Permanente-San Francisco - San Francisco, California, United States
- Kaiser Permanente-Santa Teresa-San Jose - San Jose, California, United States
- Kaiser Permanente San Leandro - San Leandro, California, United States
- Kaiser San Rafael-Gallinas - San Rafael, California, United States
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara, California, United States
- Kaiser Permanente-Santa Rosa - Santa Rosa, California, United States
- Kaiser Permanente Cancer Treatment Center - South San Francisco, California, United States
- Kaiser Permanente-South San Francisco - South San Francisco, California, United States
- Kaiser Permanente-Stockton - Stockton, California, United States
- Kaiser Permanente Medical Center-Vacaville - Vacaville, California, United States
- Kaiser Permanente-Vallejo - Vallejo, California, United States
- Kaiser Permanente-Walnut Creek - Walnut Creek, California, United States
- Memorial Hospital East - Shiloh, Illinois, United States
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters, Missouri, United States
- Siteman Cancer Center at West County Hospital - Creve Coeur, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Siteman Cancer Center-South County - St Louis, Missouri, United States
- Siteman Cancer Center at Christian Hospital - St Louis, Missouri, United States
- Billings Clinic Cancer Center - Billings, Montana, United States
- Northwell Health/Center for Advanced Medicine - Lake Success, New York, United States
- Manhattan Eye Ear and Throat Hospital - New York, New York, United States
- Lenox Hill Hospital - New York, New York, United States
- Saint Vincent Hospital - Erie, Pennsylvania, United States
- Jefferson Hospital - Jefferson Hills, Pennsylvania, United States
- Forbes Hospital - Monroeville, Pennsylvania, United States
- Allegheny General Hospital - Pittsburgh, Pennsylvania, United States
- West Penn Hospital - Pittsburgh, Pennsylvania, United States
- Wexford Health and Wellness Pavilion - Wexford, Pennsylvania, United States
- Bon Secours Saint Francis Medical Center - Midlothian, Virginia, United States
- Bon Secours Cancer Institute at Reynolds Crossing - Richmond, Virginia, United States
- VCU Massey Comprehensive Cancer Center - Richmond, Virginia, United States
- Doctor H. Bliss Murphy Cancer Centre - St. John's, Newfoundland and Labrador, Canada
- Royal Victoria Regional Health Centre - Barrie, Ontario, Canada
- Kingston Health Sciences Centre - Kingston, Ontario, Canada
- Waterloo Regional Health Network - Kitchener, Ontario, Canada
- London Regional Cancer Program - London, Ontario, Canada
- Trillium Health Partners - Credit Valley Hospital - Mississauga, Ontario, Canada
- Lakeridge Health Oshawa - Oshawa, Ontario, Canada
- Odette Cancer Centre- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada
- University Health Network-Princess Margaret Hospital - Toronto, Ontario, Canada
- CHUM - Centre Hospitalier de l'Universite de Montreal - Montreal, Quebec, Canada
- Jewish General Hospital - Montreal, Quebec, Canada