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Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer (PROSELICA)

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: March 3, 2011
Last updated: September 8, 2015
Last verified: September 2015

Primary Objective:

- To demonstrate the non inferiority in term of overall survival (OS) of cabazitaxel 20 mg/m² (Arm A) versus cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in patients with metastatic castration resistant prostate cancer (MCRPC) previously treated with a docetaxel-containing regimen.

Secondary Objectives:

  • To evaluate safety in the 2 treatment arms and to assess if cabazitaxel 20 mg/m² is better tolerated than cabazitaxel 25 mg/m².
  • To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² for:

    • Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), PSA progression, pain progression or death due to any cause
    • Prostate-Specific Antigen (PSA)-Progression
    • Pain progression
    • Tumor response in patients with measurable disease (RECIST 1.1).
    • PSA response
    • Pain response in patients with stable pain at baseline.
  • To compare Health-related Quality of Life (HRQL)
  • To assess the pharmacokinetics and pharmacogenomics of cabazitaxel

Condition Intervention Phase
Prostate Cancer
Drug: Cabazitaxel (XRP6258)
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall survival [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Enrollment: 1201
Study Start Date: April 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
cabazitaxel 20 mg/m² intravenously (Day 1) every 3 weeks Prednisone or prednisolone (if prednisone is not commercially available), 10 mg PO daily, from day 1 continuously
Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Prednisone

Pharmaceutical form:tablet

Route of administration: oral

Experimental: Arm B
cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks Prednisone or prednisolone (if prednisone is not commercially available), 10 mg PO daily, from day 1 continuously
Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Prednisone

Pharmaceutical form:tablet

Route of administration: oral

Detailed Description:
Patients will be treated until progressive disease, unacceptable toxicity, patient's refusal of further study treatment or for a maximum of 10 cycles. All patients will be followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever comes first.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion criteria :

I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is resistant to hormone therapy and previously treated with a docetaxel-containing regimen.

I 02. Patient must have either measurable or non-measurable disease. I 03. Received prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents.

I 04. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (ie, patient must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours).

I 05. Age ≥18 years (or country's legal age of majority if the legal age is > 18 years).

Exclusion criteria:

E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or radiotherapy to ≥30% of bone marrow. In case of prior isotope therapy 12 weeks must have elapsed prior to first study drug administration.

E 03. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.

E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study.

E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed ≥ 5 years ago and from which the patient has been disease-free for ≥ 5 years.

E 06. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.

E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or medical conditions E 09. 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.

E 10. Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or to comply with the study procedures or interfere with interpretation of study results.

E 11. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study.

E 12. Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" will be based on the Investigator's judgment. Patients' Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason have no chance of becoming pregnant) not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and /or in a local protocol addendum.

E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment. E 16. Symptomatic peripheral neuropathy grade > 2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.4.03).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Please refer to this study by its identifier: NCT01308580

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Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT01308580     History of Changes
Other Study ID Numbers: EFC11785  2010-022163-35 
Study First Received: March 3, 2011
Last Updated: September 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on September 28, 2016