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 (PEACE1)

NCT01957436 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	UNICANCER
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	1173
Start date	2013-11-13
Completion	2032-12

Conditions

• Metastatic Prostate Cancer

Interventions

• abiraterone acetate
• radiotherapy
• Androgen Deprivation Therapy
• Docetaxel

Primary outcomes

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

Countries

Belgium, France, Ireland, Italy, Romania, Spain, Switzerland