RecruitingPhase 2NCT05404139

Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate

Sponsor

University Health Network, Toronto

Enrollment

132 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Cancer

Summary

This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor to standard of care radiation and hormone therapy improve quality of life. Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a shorter course of hormone therapy (combined with targeted radiation to all visible cancer spots) can work just as well as a longer standard course in men with a small number of prostate cancer metastases that have not yet been treated with hormone therapy. **You may be eligible if...** - You are over 18 years old - You have prostate cancer confirmed by biopsy - You have been diagnosed within the past 6 months with 1–10 metastases (no more than 1 visible on conventional CT or bone scan) - Your cancer is hormone-sensitive (castrate-sensitive) - You are well enough to participate (ECOG 0–2) **You may NOT be eligible if...** - You have previously been treated with hormone therapy or chemotherapy for prostate cancer - You have been on hormone therapy for more than 3 months - You have more than 10 metastatic deposits on advanced imaging - You have significant heart problems 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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