Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy

Phase 3

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiotherapy; Drug: Leuprorelin

• Registration Number: NCT04302454
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Study Start: 2020-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-10-21
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy without hormonal therapy	Radiotherapy	Metastase-directed radiotherapy without the addition of hormonal therapy
Radiotherapy combined with hormonal therapy	Radiotherapy	Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)
Radiotherapy combined with hormonal therapy	Leuprorelin	Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)

Primary Outcome Measures

Name	Time	Method
Metastases progression-free survival (MPFS)	2.5 years after treatment	The primary aim of this project is to test the hypothesis that the addition of ADT to MDRT in well-selected PCa patients with oligo-metastatic disease (OM) prolongs the metastases progression-free survival (MPFS) compared to MDRT alone

Trial Locations

Locations (12)

Radiotherapy Institute Friesland; 🇳🇱 Leeuwarden, Friesland, Netherlands

Radiotherapiegroep; 🇳🇱 Deventer, Overijssel, Netherlands

Radboud University Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands

Maastro Clinic; 🇳🇱 Maastricht, Limburg, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Amsterdam UMC (Location VUmc); 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Isala; 🇳🇱 Zwolle, Overijssel, Netherlands

Haga Hospital; 🇳🇱 Den Haag, Zuid-Holland, Netherlands

Leinden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

UMCG; 🇳🇱 Groningen, Netherlands

Verbeeten Institute; 🇳🇱 Tilburg, Netherlands