RecruitingPhase 2NCT06654336

Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)

Phase II Randomized Trial of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC).


Sponsor

Ontario Clinical Oncology Group (OCOG)

Enrollment

162 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether treating the sites of cancer recurrence with radiation or surgery (recurrence-directed therapy, or RDT) — with or without hormone therapy — is beneficial for men with prostate cancer that has returned after prior radiation therapy, when the cancer has spread to only a few spots (oligometastatic). **You may be eligible if...** - You have previously been treated with definitive radiation therapy for localized prostate cancer, at least 2 years ago - Your prostate cancer has come back and is now present in 5 or fewer metastatic sites on imaging (including advanced scans like PSMA-PET) - Your PSA level is rising but your testosterone is not yet at castrate levels - All sites of recurrence can potentially be treated with radiation or surgery **You may NOT be eligible if...** - You have more than 5 metastatic sites - Your prostate cancer is castration-resistant (no longer responding to hormone therapy) - Your recurrence sites cannot safely be targeted with local treatment 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONRecurrence-directed therapy (RDT)

RDT options include radiotherapy or surgical resection.

DRUGELIGARD 22.5mg

ADT in the form of ELIGARD 22.5 mg every 3 months for a total of 12 months.


Locations(3)

Juravinski Cancer Centre

Hamilton, Ontario, Canada

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06654336


Related Trials