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Clinical Trials/NCT04302454
NCT04302454
Active, not recruiting
Phase 3

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

University Medical Center Groningen12 sites in 1 country280 target enrollmentMarch 19, 2020

Overview

Phase
Phase 3
Intervention
Radiotherapy
Conditions
Prostate Cancer
Sponsor
University Medical Center Groningen
Enrollment
280
Locations
12
Primary Endpoint
Metastases progression-free survival (MPFS)
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 19, 2020
End Date
December 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Radiotherapy without hormonal therapy

Metastase-directed radiotherapy without the addition of hormonal therapy

Intervention: Radiotherapy

Radiotherapy combined with hormonal therapy

Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)

Intervention: Radiotherapy

Radiotherapy combined with hormonal therapy

Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)

Intervention: Leuprorelin

Outcomes

Primary Outcomes

Metastases progression-free survival (MPFS)

Time Frame: 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

Study Sites (12)

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