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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.

NCT04139772 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

  • Metastatic Castration-resistent Prostate Cancer

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Sandro Pignata, MD, PhD · National Cancer Institute, Naples

  • Gaetano Facchini, MD · National Cancer Institute, Naples

  • Francesco Perrone, MD, PhD · National Cancer Institute, Naples

  • Orazio Caffo, MD · Oncology Department, Ospedale Santa Chiara, Trento

  • Clorinda Schettino, MD · National Cancer Institute, Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-12-01
Completion
2024-07-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT04139772 on ClinicalTrials.gov