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NCT06235697PHASE3Recruiting

Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

Canadian Cancer Trials Group

Start Date

4/25/2024

Completion Date

4/30/2033

Summary

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)?

Detailed Description

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

Age Range: 18 years to No maximum

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.

Interventions

RADIATION

Radiation

RADIATION

Radiation SBRT only

DRUG

ADT

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Conditions

Prostate Cancer

Locations

Kaiser Permanente-Deer Valley Medical Center

Antioch, California 94531

United States

Kaiser Permanente Dublin

Dublin, California 94568

United States

Kaiser Permanente-Fremont

Fremont, California 94538

United States

Kaiser Permanente Fresno Orchard Plaza

Fresno, California 93720

United States

Kaiser Permanente-Fresno

Fresno, California 93720

United States

Kaiser Permanente-Modesto

Modesto, California 95356

United States

Kaiser Permanente Oakland-Broadway

Oakland, California 94611

United States

Kaiser Permanente-Oakland

Oakland, California 94611

United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California 94063

United States

Kaiser Permanente-Richmond

Richmond, California 94801

United States

Rohnert Park Cancer Center

Rohnert Park, California 94928

United States

Kaiser Permanente-Roseville

Roseville, California 95661

United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California 95678

United States

Kaiser Permanente Downtown Commons

Sacramento, California 95814

United States

Kaiser Permanente-South Sacramento

Sacramento, California 95823

United States

Kaiser Permanente-San Francisco

San Francisco, California 94115

United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California 95119

United States

Kaiser Permanente San Leandro

San Leandro, California 94577

United States

Kaiser San Rafael-Gallinas

San Rafael, California 94903

United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California 95051

United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California 95403

United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California 94080

United States

Kaiser Permanente-South San Francisco

South San Francisco, California 94080

United States

Kaiser Permanente-Stockton

Stockton, California 95210

United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California 95688

United States

Kaiser Permanente-Vallejo

Vallejo, California 94589

United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California 94596

United States

Memorial Hospital East

Shiloh, Illinois 62269

United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri 63376

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri 63141

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Siteman Cancer Center-South County

St Louis, Missouri 63129

United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri 63136

United States

Billings Clinic Cancer Center

Billings, Montana 59101

United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York 11042

United States

Manhattan Eye Ear and Throat Hospital

New York, New York 10065

United States

Lenox Hill Hospital

New York, New York 10075

United States

Saint Vincent Hospital

Erie, Pennsylvania 16544

United States

Jefferson Hospital

Jefferson Hills, Pennsylvania 15025

United States

Forbes Hospital

Monroeville, Pennsylvania 15146

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

West Penn Hospital

Pittsburgh, Pennsylvania 15224

United States

Wexford Health and Wellness Pavilion

Wexford, Pennsylvania 15090

United States

Bon Secours Saint Francis Medical Center

Midlothian, Virginia 23114

United States

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia 23230

United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia 23298

United States

Doctor H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador A1B 3V6

Canada

Royal Victoria Regional Health Centre

Barrie, Ontario L4M 6M2

Canada

Kingston Health Sciences Centre

Kingston, Ontario K7L 2V7

Canada

Waterloo Regional Health Network

Kitchener, Ontario N2G 1G3

Canada

London Regional Cancer Program

London, Ontario N6A 4L6

Canada

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario L5M 2N1

Canada

Lakeridge Health Oshawa

Oshawa, Ontario L1G 2B9

Canada

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Canada

University Health Network-Princess Margaret Hospital

Toronto, Ontario M5G 2M9

Canada

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec H2X 3E4

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada