Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
NCT ID: NCT06235697
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
710 participants
INTERVENTIONAL
2024-04-25
2033-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer
NCT04599686
Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy
NCT00175396
Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer
NCT05628363
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
NCT04489745
Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
NCT00006359
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EBRT + Brachy Boost
Radiation
46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate OR 25Gy / 5 fractions of EBRT to pelvis and prostate (ultrahypofractionation EBRT (SBRT)) + LDR or HDR boost to prostate.
\+ Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24 months
ADT
Assigned at enrollment
SBRT
Radiation SBRT only
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiation
46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate OR 25Gy / 5 fractions of EBRT to pelvis and prostate (ultrahypofractionation EBRT (SBRT)) + LDR or HDR boost to prostate.
\+ Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24 months
Radiation SBRT only
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
ADT
Assigned at enrollment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NRG Oncology
OTHER
Canadian Cancer Trials Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Loblaw
Role: STUDY_CHAIR
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Oakland, California, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, 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-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
Jewish General Hospital
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2023-09091
Identifier Type: OTHER
Identifier Source: secondary_id
CCTG-PR24
Identifier Type: OTHER
Identifier Source: secondary_id
CCTG-PR24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.