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Optimal Sequencing of Treatment Options for Poor Risk mCRPC Previously Treated With Docetaxel

NCT03295565 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-15

No results posted yet for this study

Summary

Rationale:

The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life.

Objective:

The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B).

Intervention:

Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive abiraterone and prednisone OR enzalutamide.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and are reimbursed. Risk of side effects or death as a result of treatment is not affected by the trial design. At baseline, prior to each treatment cycle and at end of treatment, patients are requested to visit the out-patient clinic, where a physical exam will be performed in combination with vena puncture for blood analysis. Radiological evaluation will be performed at base line, after 3 months of treatment and at end of treatment. All above mentioned interventions can be considered as standard practice. Patients are requested to fill out QoL and pain/analgesic use questionnaires at base line, prior to each cycle and at end of treatment.

Conditions

  • Prostate Cancer Metastatic
  • Metastasis

Interventions

DRUG

Cabazitaxel

Cabazitaxel 25mg/m2 IV, once every 3 weeks

DRUG

Abiraterone

Abiraterone 1000mg oral, taken daily + Prednisone 5mg oral, 2 times a day

DRUG

Enzalutamide

Enzalutamide 160mg oral taken daily

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-07
Primary Completion
2020-12-16
Completion
2022-03-02

Countries

  • Netherlands

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 NCT03295565 on ClinicalTrials.gov