RecruitingPhase 3NCT06235697

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


Sponsor

Canadian Cancer Trials Group

Enrollment

710 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

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)?


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of hormone-blocking therapy (androgen suppression), radiation to the pelvic lymph nodes, and high-dose prostate radiation (including brachytherapy — radioactive seeds placed directly in the prostate) for men with higher-risk prostate cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with prostate cancer within the last 9 months - Your cancer is classified as unfavorable intermediate, high, or very high risk based on tumor characteristics, Gleason score, or PSA level - You are medically fit for brachytherapy (radioactive seed treatment) - You are able to complete quality-of-life questionnaires in English, French, or Spanish **You may NOT be eligible if...** - You have distant metastases (cancer that has spread beyond the prostate and nearby lymph nodes) - You are not fit for surgical procedures or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation

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

RADIATIONRadiation SBRT only

25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))

DRUGADT

Assigned at enrollment


Locations(57)

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

View Full Details on ClinicalTrials.gov

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NCT06235697


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