NCT01957436

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

A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,173 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-11-13
• Primary completion: 2021-08-18
• Completion: 2032-12-01
• First posted: 2013-10-08
• Last updated: 2024-11-12

Locations

77 sites across 7 countries: Belgium, France, Ireland, Italy, Romania, Spain, Switzerland