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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Active Not Recruiting PHASE3 INTERVENTIONAL NCT01957436

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked. The randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio. The randomization will be stratified (by minimization) according to: * enrolment center, * performance status (0 vs. 1-2) * disease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases. CRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (\<0.50 ng/mL). When the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients. Investigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines. Abiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.

Interventions

Name: abiraterone acetate
Type: DRUG
Description: abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid
Name: radiotherapy
Type: RADIATION
Description: 74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)
Name: Androgen Deprivation Therapy
Type: OTHER
Description: The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy
Name: Docetaxel
Type: DRUG
Description: 6 cycles at 75mg/m²/cycle, one cycle every 3 weeks

Primary Outcomes

Measure: Survival
TimeFrame: 7.5 years after the first inclusion
Description: Overall and radiographic progression-free survival in patients with metastatic hormone-naïve prostate cancer treated by androgen deprivation therapy and docetaxel
Measure: Survival
TimeFrame: 9.5 years after the first inclusion
Description: Overall and radiographic progression-free survival in hormone-naïve prostate cancer patients with low metastatic burden whatever the standard of care received

Trial Information

NCT ID

NCT01957436

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

UNICANCER

Last Updated

December 15, 2025