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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Unknown PHASE2 INTERVENTIONAL NCT03940235

Radioablation With or Without Androgen DeprIvation Therapy in Metachronous Prostate Cancer OligometaStAsis

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

A randomized phase II clinical trial (RADIOSA trial: Radioablation with or without Androgen DeprIvation therapy in metachronous prostate cancer OligometaStAsis). The aim is to compare time to progression between the two study arms: SBRT only or SBRT and hormonotherapy (ADT). The primary objective is to compare the progression-free survival (PFS) defined as the absence of new metastatic lesions (local, regional or distant) between the two arms. The secondary endpoints include the comparison of overall survival (OS), biochemical progression-free survival (BPFS), ADT-free survival, local control, treatment-induced acute and late toxicity, time to castration-resistant disease and QoL between the two arms; the development of a dedicated biobanking (collection of plasma and serum) for further biological investigation of predictive/diagnostic factors for personalized treatment; the preliminary evaluation of prognostic biomarkers; the correlation between imaging-derived parameters and treatment outcome.

Interventions

Name: Androgen deprivation therapy (ADT)
Type: DRUG
Description: SBRT + ADT
Name: SBRT
Type: RADIATION
Description: SBRT to all radiological documented lesions (bone or lymphnodes)

Primary Outcomes

Measure: Progression-free survival (PFS)
TimeFrame: up 3 months from the end of the treatment up to radiological progression within 3 years
Description: Defined as the absence of new metastatic lesions (local, regional or distant) between the two arms.

Trial Information

NCT ID

NCT03940235

Status

Unknown

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

European Institute of Oncology

Last Updated

December 15, 2025