NCT06585007

Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer

Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer: a Randomized Phase 3 Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.

Detailed description

MEDCARE phase 3 trial is approved by the central Ethics committee. It is a multicentric, randomized, prospective, open-label, two-arm, phase III trial. The aim is to evaluate the impact of progression-directed therapy (PDT) in patients presenting with oligoprogressive mCRPC on overall survival (OS). The study will employ a 1:1 randomization between arm A and arm B. Patients will be stratified according to number of metastases (1 versus \> 1), initial localization (local recurrence, N or M1a vs. M1b or M1c) and systemic therapy (patient type 1 vs. type 2, see below) (Fig 1). Randomization will be carried out after approval in the multidisciplinary tumour board were the standard-of-care treatment and kind of PDT (metastasectomy or SBRT) will be decided before randomization.

Conditions

• Castration-resistant Prostate Cancer
• Oligoprogressive

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Progression-directed therapy (stereotactic body radiation therapy)
PROCEDURE	metastasectomy	Progression-directed therapy (metastasectomy)

Timeline

• Start date: 2023-12-19
• Primary completion: 2029-01-20
• Completion: 2029-01-20
• First posted: 2024-09-05
• Last updated: 2024-09-05

Locations

1 site across 1 country: Belgium