NCT04139772

Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.

A Randomized Multicenter Phase III Trial Comparing Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized phase 3 trial aiming to compare the efficacy of docetaxel and hormone therapy as second line treatment in patients with mCRPC progressing after therapy with abiraterone or enzalutamide.

Detailed description

Patients will be randomized 1:1 to receive docetaxel or hormone therapy (abiraterone or enzalutamide based on previous treatment). Docetaxel (standard) will be administered for 10 cycles (maximum). Hormone therapy (experimental) will be administered until progression or unacceptable toxicity.

Conditions

• Metastatic Castration-resistent Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.
DRUG	Abiraterone Acetate or Enzalutamide	Patient will receive Abiraterone or Enzalutamide based on previous treatment. Abiraterone given orally at the dose of 1000 mg daily plus oral prednisone 5 mg twice daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment. Enzalutamide given orally at the dose of 160 mg daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment.

Timeline

• Start date: 2019-09-01
• Primary completion: 2023-12-01
• Completion: 2024-07-01
• First posted: 2019-10-25
• Last updated: 2023-03-24

Locations

1 site across 1 country: Italy