RecruitingPhase 3NCT05352178

Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

873 participants

Start Date

Apr 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether precisely targeting the specific sites where prostate cancer has returned (using radiation or other local therapies) delays the need to start hormone therapy in men with a small number of cancer recurrences after treatment. **You may be eligible if...** - You are 18 or older with a confirmed history of prostate cancer - Your primary tumor was previously treated and controlled - Your PSA is rising after surgery or radiation, indicating cancer has returned - You have 5 or fewer cancer spots visible on a PSMA PET scan - Your testosterone level is within the normal range **You may NOT be eligible if...** - You have more than 5 metastatic spots - Your testosterone is already at castrate (very low) levels, meaning you're already on hormone therapy - You have another active cancer besides prostate cancer - You have heart conditions that prevent you from taking enzalutamide (e.g., history of seizures or recent heart attack) - Previous treatments make new radiation therapy technically impossible 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

OTHERRadiotherapy (SBRT) and/or surgery (metastasectomy)

Metastasis-directed therapay (surgery and/or radiotherapy) as treatment for oligorecurrent lesions

DRUGAndrogen deprivation therapy

Arm B: gosereline 3.6 mg sc, leuproreline 7.5 mg sc, triptoreline 3.75 mg im Arm C: gosereline 3.6 mg sc 1x/month or gosereline 10.8 mg sc or leuproreline 7.5 mg sc 1x/month or leuproreline 45 mg sc or triptoreline 3.75 mg im 1x/month or triptoreline 11.5 mg im 1x/3months or triptoreline 22.5 mg im

DRUGAndrogen receptor targeted therapy

Enzalutamide


Locations(1)

University Hospitals Leuven

Leuven, Belgium

View Full Details on ClinicalTrials.gov

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

Visit

NCT05352178


Related Trials