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A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

NCT01957436 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1173

Last updated 2024-11-12

No results posted yet for this study

Summary

This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

Conditions

Interventions

DRUG

abiraterone acetate

abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid

RADIATION

radiotherapy

74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)

OTHER

Androgen Deprivation Therapy

The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy

DRUG

Docetaxel

6 cycles at 75mg/m²/cycle, one cycle every 3 weeks

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Ipsen

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Karim FIZAZI, Professor · Gustave Roussy, Cancer Campus Grand Paris - Paris

  • Alberto BOSSI, Doctor · Gustave Roussy, Cancer Campus Grand Paris - Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-13
Primary Completion
2021-08-18
Completion
2032-12-31

Countries

  • Belgium
  • France
  • Ireland
  • Italy
  • Romania
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01957436 on ClinicalTrials.gov