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Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer

NCT03488810 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-08-17

No results posted yet for this study

Summary

The main objective of the trial to determine if the combination of apalutamide with 6 months of androgen deprivation therapy by LHRH agonists in patients with intermediate and limited high-risk, localized prostate cancer receiving primary radiation therapy (RT) results in an improvement of disease-free survival (DFS) evaluated by the treating physician, in comparison to the combination of radiation and androgen deprivation therapy without the addition of apalutamide.

Conditions

Interventions

OTHER

Radiation Therapy

Dose escalated Intensity-Modulated Radiation therapy (IMRT) with conventional fractionation, hypofractionation and prostate brachytherapy are allowed.

DRUG

Apalutamide

240 mg PO daily, started the same day as the first LHRHa injection, for 6 months

DRUG

Luteinising Hormone Releasing Hormone analog agonist (LHRHa)

2 injections of a three-monthly LHRH agonist depot

DRUG

Non-steroidal anti-androgen

Non-steroidal anti-androgen (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Gilles Crehange · Centre Georges Francois Leclerc

  • Michel Bolla · CHU de Grenoble - La Tronche - Hôpital A. Michallon, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2026-06-15
Completion
2026-06-15

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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 NCT03488810 on ClinicalTrials.gov