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

NCT03940235 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-06-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Androgen deprivation therapy (ADT)

SBRT + ADT

RADIATION

SBRT

SBRT to all radiological documented lesions (bone or lymphnodes)

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Barbara A Jereczek-Fossa, Prof · Istituto Europeo di Oncologia IRCCS Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-12-01
Completion
2024-04-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940235 on ClinicalTrials.gov