RecruitingPhase 2NCT04070209

Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)

The Role of Therapeutic Layering of Stereotactic Body Radiotherapy on Darolutamide in the Management of Oligoprogressive Castration Resistant Prostate Cancer: a Pilot Phase II Trial


Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Enrollment

66 participants

Start Date

Oct 19, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is the first pilot phase II trial assessing the response of SBRT layered on Darolutamide (BAY1841788) on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the best treatment approach for men with prostate cancer that has stopped responding to hormone therapy (called castration-resistant prostate cancer, or CRPC) and is showing limited progression in a small number of spots. Researchers want to know if targeting those few progressing areas with radiation can delay the cancer from spreading further. **You may be eligible if...** - You have been diagnosed with castration-resistant prostate cancer (prostate cancer that keeps growing despite hormone-lowering treatment) - Your testosterone levels are very low (at or below 50 ng/dL) - Your PSA levels have risen on at least two consecutive measurements - Your cancer has not spread visibly to organs on standard scans - Your PSA doubling time is 10 months or less **You may NOT be eligible if...** - Your cancer has spread widely to multiple areas - You do not meet the specific PSA progression or testosterone criteria - Your cancer has grown beyond what targeted radiation could address 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

DRUGDarolutamide (BAY1841788)

Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.

RADIATIONSBRT

SBRT will consist of 2-5 fractions of highly targeted radiation therapy delivered every other day. The radiation component will be completed in 4-10 days.


Locations(10)

Prostate Cancer Centre

Calgary, Alberta, Canada

Centre of Applied Urology Research

Halifax, Nova Scotia, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Service d'urologie et Centre de la prostate

Longueuil, Quebec, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Sir Mortimer JGH

Montreal, Quebec, Canada

L'Hôtel-Dieu de Québec (CHUQ)

Québec, Quebec, Canada

Hôpital Fleurimont (CHUS)

Sherbrooke, Quebec, Canada

Centre hospitalier affilié universitaire régional (CHAUR)

Trois-Rivières, Quebec, Canada

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NCT04070209


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