Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer (CABA-DOC)

March 31, 2026 updated by: Gustave Roussy, Cancer Campus, Grand Paris

A Study of Patient Preference Between Cabazitaxel and Docetaxel in First-line Chemotherapy for Metastatic Castrate-resistant Prostate Cancer

Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles.

Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting.

The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib.

A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future.

Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val de Marne
      • Villejuif, Val de Marne, France, 94805
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Affiliated to a social security regimen ;
  • Male patients older than 18 years ;
  • Histologically confirmed adenocarcinoma of the prostate ;
  • Continued androgen deprivation therapy either by LHRH agonists/antagonists or orchidectomy ;
  • Serum testosterone <0.50 ng/ml (1.7 nmol/L) ;
  • Progressive disease (PSA progression or radiological progression or clinical progression) ;
  • ECOG 0-2 ;
  • Information delivered to patient and informed consent form signed by the patient or his legal representative ;

  • Adequate organ or bone marrow function as evidenced by:

    • Hemoglobin >/= 10 g/dL
    • Absolute neutrophil count >/=1.5 x 109/L,
    • Platelet count >/=100 x 109/L,
    • AST/SGOT and/or ALT/SGPT </=1.5 x ULN;
    • Total bilirubin </=1.5 x ULN,
    • Serum creatinine </=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded

Exclusion Criteria:

  • Patients having received an investigational drug and/or prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior enrolment in the study, excepted radiotherapy directed to a single bone lesions which is nonacceptable if within 2 weeks ;
  • Prior treatment with Taxotere or Jevtana ;
  • Pre-existing symptomatic peripheral neuropathy grade > 2 (CTCAE V4) ;
  • Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed ;
  • History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs ;
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus), active infection including HIV infection, active Hepatitis B or C infection that would preclude participation in the trial ;
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) ;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Do/Ca
Arm Do/Ca : Taxotere 75mg/m2/3w x 4 cycles, followed by Jevtana 25mg/m2/3w x 4 cycles
Drug: Taxotere
Drug: Jevtana
Other: Ca/Do
Arm Ca/Do : Jevtana 25mg/m2/3w x 4 cycles, followed by Taxotere 75mg/m2/3w x 4 cycles
Drug: Taxotere
Drug: Jevtana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient preference
Time Frame: Assessed up 21 weeks after randomization

Patient preference (Taxotere versus Jevtana) assessed by a single question after completion of the second period of chemotherapy.

Primary outcome measure will be assessed in the intent-to-treat population as defined by all patients having completed the first 4 cycles without progression and having received at least 1 cycle of the second treatment period. Patients having progressed during the first period will discontinue the trial.
Assessed up 21 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

Sanofi

Investigators

  • Study Chair: Karim Fizazi, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2014

Primary Completion (Actual)

April 13, 2017

Study Completion (Actual)

December 22, 2017

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimated)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-004243-22
  • 2013/2072 (Other Identifier: CSET number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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