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Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

NCT06235697 · Canadian Cancer Trials Group
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Official title
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
About this study
The usual approach for patients with unfavourable prostate cancer who are not in a study is treatment with external beam radiation therapy (EBRT) to the pelvis and prostate in combination with hormone therapy (androgen deprivation therapy - ADT). To improve control of prostate cancer at risk of returning, additional treatment with a brachytherapy boost (insertion of radiation sources directly into the prostate) is recommended. For patients who get the usual approach for this cancer, about 89 out of 100 are free of cancer after 5 years.
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 design
Enrollment target: 710 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-04-25
Estimated completion: 2033-04-30
Last updated: 2026-04-14
Interventions
Radiation: RadiationRadiation: Radiation SBRT onlyDrug: ADT
Primary outcomes
  • 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 (8.6 years)
Sponsor
Canadian Cancer Trials Group · network
With: NRG Oncology
Contacts & investigators
ContactWendy Parulekar · contact · wparulekar@ctg.queensu.ca · 613-533-6430
InvestigatorAndrew Loblaw · study_chair, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
All locations (57)
Kaiser Permanente-Deer Valley Medical CenterRecruiting
Antioch, California, United States
Kaiser Permanente DublinRecruiting
Dublin, California, United States
Kaiser Permanente-FremontRecruiting
Fremont, California, United States
Kaiser Permanente Fresno Orchard PlazaRecruiting
Fresno, California, United States
Kaiser Permanente-FresnoRecruiting
Fresno, California, United States
Kaiser Permanente-ModestoRecruiting
Modesto, California, United States
Kaiser Permanente Oakland-BroadwayRecruiting
Oakland, California, United States
Kaiser Permanente-OaklandRecruiting
Oakland, California, United States
Kaiser Permanente- Marshall Medical OfficesRecruiting
Redwood City, California, United States
Kaiser Permanente-RichmondRecruiting
Richmond, California, United States
Rohnert Park Cancer CenterRecruiting
Rohnert Park, California, United States
Kaiser Permanente-RosevilleRecruiting
Roseville, California, United States
The Permanente Medical Group-Roseville Radiation OncologyRecruiting
Roseville, California, United States
Kaiser Permanente Downtown CommonsRecruiting
Sacramento, California, United States
Kaiser Permanente-South SacramentoRecruiting
Sacramento, California, United States
Kaiser Permanente-San FranciscoRecruiting
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San JoseRecruiting
San Jose, California, United States
Kaiser Permanente San LeandroRecruiting
San Leandro, California, United States
Kaiser San Rafael-GallinasRecruiting
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa ClaraRecruiting
Santa Clara, California, United States
Kaiser Permanente-Santa RosaRecruiting
Santa Rosa, California, United States
Kaiser Permanente Cancer Treatment CenterRecruiting
South San Francisco, California, United States
Kaiser Permanente-South San FranciscoRecruiting
South San Francisco, California, United States
Kaiser Permanente-StocktonRecruiting
Stockton, California, United States
Kaiser Permanente Medical Center-VacavilleRecruiting
Vacaville, California, United States
Kaiser Permanente-VallejoRecruiting
Vallejo, California, United States
Kaiser Permanente-Walnut CreekRecruiting
Walnut Creek, California, United States
Memorial Hospital EastRecruiting
Shiloh, Illinois, United States
Siteman Cancer Center at Saint Peters HospitalRecruiting
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County HospitalRecruiting
Creve Coeur, Missouri, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Siteman Cancer Center-South CountyRecruiting
St Louis, Missouri, United States
Siteman Cancer Center at Christian HospitalRecruiting
St Louis, Missouri, United States
Billings Clinic Cancer CenterRecruiting
Billings, Montana, United States
Northwell Health/Center for Advanced MedicineRecruiting
Lake Success, New York, United States
Manhattan Eye Ear and Throat HospitalRecruiting
New York, New York, United States
Lenox Hill HospitalRecruiting
New York, New York, United States
Saint Vincent HospitalRecruiting
Erie, Pennsylvania, United States
Jefferson HospitalRecruiting
Jefferson Hills, Pennsylvania, United States
Forbes HospitalRecruiting
Monroeville, Pennsylvania, United States
Allegheny General HospitalRecruiting
Pittsburgh, Pennsylvania, United States
West Penn HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Wexford Health and Wellness PavilionRecruiting
Wexford, Pennsylvania, United States
Bon Secours Saint Francis Medical CenterRecruiting
Midlothian, Virginia, United States
Bon Secours Cancer Institute at Reynolds CrossingRecruiting
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer CenterRecruiting
Richmond, Virginia, United States
Doctor H. Bliss Murphy Cancer CentreRecruiting
St. John's, Newfoundland and Labrador, Canada
Royal Victoria Regional Health CentreRecruiting
Barrie, Ontario, Canada
Kingston Health Sciences CentreRecruiting
Kingston, Ontario, Canada
Waterloo Regional Health NetworkRecruiting
Kitchener, Ontario, Canada
London Regional Cancer ProgramRecruiting
London, Ontario, Canada
Trillium Health Partners - Credit Valley HospitalRecruiting
Mississauga, Ontario, Canada
Lakeridge Health OshawaRecruiting
Oshawa, Ontario, Canada
Odette Cancer Centre- Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
University Health Network-Princess Margaret HospitalRecruiting
Toronto, Ontario, Canada
CHUM - Centre Hospitalier de l'Universite de MontrealRecruiting
Montreal, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment · TrialPath