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

Prostate Cancer Clinical Trial

— PROSELICA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308580
• Other study ID #: EFC11785
• Secondary ID: 2010-022163-35
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2011
• Last updated: September 8, 2015
• Start date: April 2011
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1201
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Cabazitaxel (XRP6258)
Pharmaceutical form:solution Route of administration: intravenous
• Prednisone
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Argentina	Investigational Site Number 032002	Buenos Aires
Argentina	Investigational Site Number 032001	Rosario
Argentina	Investigational Site Number 032003	Salta
Argentina	Investigational Site Number 032004	Santa Fe
Australia	Investigational Site Number 036014	Adelaide
Australia	Investigational Site Number 036013	Bankstown
Australia	Investigational Site Number 036010	Box Hill
Australia	Investigational Site Number 036012	Camperdown
Australia	Investigational Site Number 036008	Coffs Harbour
Australia	Investigational Site Number 036001	Concord
Australia	Investigational Site Number 036015	Elizabeth Vale
Australia	Investigational Site Number 036009	Fitzroy
Australia	Investigational Site Number 036007	Garran
Australia	Investigational Site Number 036005	Heidelberg West
Australia	Investigational Site Number 036002	Malvern
Australia	Investigational Site Number 036006	South Brisbane
Australia	Investigational Site Number 036016	Subiaco
Australia	Investigational Site Number 036003	Wahroonga
Australia	Investigational Site Number 036004	Wodonga
Belgium	Investigational Site Number 056007	Antwerpen
Belgium	Investigational Site Number 056008	Brussel
Belgium	Investigational Site Number 056001	Bruxelles
Belgium	Investigational Site Number 056002	Bruxelles
Belgium	Investigational Site Number 056009	Charleroi
Belgium	Investigational Site Number 056003	Gent
Belgium	Investigational Site Number 056012	Godinne
Belgium	Investigational Site Number 056016	Haine-Saint-Paul
Belgium	Investigational Site Number 056005	Hasselt
Belgium	Investigational Site Number 056010	Libramont
Belgium	Investigational Site Number 056013	Liège
Belgium	Investigational Site Number 056011	Ottignies
Belgium	Investigational Site Number 056004	Roeselare
Belgium	Investigational Site Number 056006	Turnhout
Brazil	Investigational Site Number 076016	Fortaleza
Brazil	Investigational Site Number 076012	Ijui
Brazil	Investigational Site Number 076015	Mogi Das Cruzes
Brazil	Investigational Site Number 076014	Porto Alegre
Brazil	Investigational Site Number 076010	Rio De Janeiro
Brazil	Investigational Site Number 076007	Salvador
Brazil	Investigational Site Number 076003	Sao Jose Do Rio Preto
Brazil	Investigational Site Number 076001	Sao Paulo
Brazil	Investigational Site Number 076002	Sao Paulo
Brazil	Investigational Site Number 076008	Sao Paulo
Brazil	Investigational Site Number 076009	Sao Paulo
Brazil	Investigational Site Number 076013	Sao Paulo
Canada	Investigational Site Number 124002	Greenfield Park
Canada	Investigational Site Number 124001	Oshawa
Canada	Investigational Site Number 124003	Ottawa
Canada	Investigational Site Number 124005	Owen Sound
Chile	Investigational Site Number 152002	Santiago
Chile	Investigational Site Number 152004	Santiago
Chile	Investigational Site Number 152005	Santiago
Chile	Investigational Site Number 152001	Viña Del Mar
France	Investigational Site Number 250005	Avignon Cedex 9
France	Investigational Site Number 250008	Hyeres
France	Investigational Site Number 250001	La Roche Sur Yon
France	Investigational Site Number 250002	Nantes Cedex 2
France	Investigational Site Number 250004	Nimes
France	Investigational Site Number 250010	Paris
France	Investigational Site Number 250007	Reims
France	Investigational Site Number 250009	Reims Cedex
France	Investigational Site Number 250006	Saint Brieuc Cedex
France	Investigational Site Number 250011	Toulouse Cedex 03
France	Investigational Site Number 250003	Toulouse Cedex 09
Germany	Investigational Site Number 276003	Aachen
Germany	Investigational Site Number 276007	Dresden
Germany	Investigational Site Number 276004	Düsseldorf
Germany	Investigational Site Number 276001	Erlangen
Germany	Investigational Site Number 276005	Hamburg
Germany	Investigational Site Number 276011	Hamburg
Germany	Investigational Site Number 276010	Homburg
Germany	Investigational Site Number 276006	München
Germany	Investigational Site Number 276012	Nürtingen
Germany	Investigational Site Number 276008	Tübingen
Germany	Investigational Site Number 276002	Wuppertal
Hungary	Investigational Site Number 348001	Budapest
Hungary	Investigational Site Number 348004	Budapest
Hungary	Investigational Site Number 348005	Budapest
Hungary	Investigational Site Number 348006	Miskolc
Hungary	Investigational Site Number 348003	Pécs
Korea, Republic of	Investigational Site Number 410003	Seongnam
Korea, Republic of	Investigational Site Number 410001	Seoul
Korea, Republic of	Investigational Site Number 410002	Seoul
Korea, Republic of	Investigational Site Number 410004	Seoul
Korea, Republic of	Investigational Site Number 410005	Seoul
Netherlands	Investigational Site Number 528005	Arnhem
Netherlands	Investigational Site Number 528003	Blaricum
Netherlands	Investigational Site Number 528004	Hoofddorp
Netherlands	Investigational Site Number 528002	Nijmegen
Netherlands	Investigational Site Number 528001	Zwolle
Peru	Investigational Site Number 604003	Arequipa
Peru	Investigational Site Number 604001	Lima
Peru	Investigational Site Number 604002	Lima
Peru	Investigational Site Number 604004	Lima
Peru	Investigational Site Number 604005	Lima
Peru	Investigational Site Number 604006	Lima
Peru	Investigational Site Number 604007	Lima
Poland	Investigational Site Number 616006	Lubin
Poland	Investigational Site Number 616002	Olsztyn
Poland	Investigational Site Number 616001	Rybnik
Poland	Investigational Site Number 616005	Siedlce
Poland	Investigational Site Number 616004	Torun
Romania	Investigational Site Number 642005	Alba Iulia
Romania	Investigational Site Number 642006	Baia Mare
Romania	Investigational Site Number 642008	Bucuresti
Romania	Investigational Site Number 642009	Bucuresti
Romania	Investigational Site Number 642001	Cluj Napoca
Romania	Investigational Site Number 642002	Cluj Napoca
Romania	Investigational Site Number 642003	Cluj Napoca
Romania	Investigational Site Number 642004	Cluj Napoca
Romania	Investigational Site Number 642012	Focsani
Romania	Investigational Site Number 642007	Hunedoara
Romania	Investigational Site Number 642013	Onesti
Russian Federation	Investigational Site Number 643009	Ekaterinburg
Russian Federation	Investigational Site Number 643004	Moscow
Russian Federation	Investigational Site Number 643005	Moscow
Russian Federation	Investigational Site Number 643006	Moscow
Russian Federation	Investigational Site Number 643007	Moscow
Russian Federation	Investigational Site Number 643008	Obninsk
Russian Federation	Investigational Site Number 643001	St.Petersburg
Russian Federation	Investigational Site Number 643010	St.Petersburg
Russian Federation	Investigational Site Number 643003	Tula
South Africa	Investigational Site Number 710003	Cape Town
South Africa	Investigational Site Number 710002	Durban
South Africa	Investigational Site Number 710004	Johannesburg
South Africa	Investigational Site Number 710005	Johannesburg
South Africa	Investigational Site Number 710001	Pretoria
Spain	Investigational Site Number 724003	Badalona
Spain	Investigational Site Number 724001	Barcelona
Spain	Investigational Site Number 724002	Madrid
Spain	Investigational Site Number 724008	Madrid
Spain	Investigational Site Number 724006	Málaga
Spain	Investigational Site Number 724005	Palma De Mallorca
Spain	Investigational Site Number 724004	Sabadell
Spain	Investigational Site Number 724007	Sevilla
Taiwan	Investigational Site Number 158002	Taiching
Taiwan	Investigational Site Number 158003	Tainan
Taiwan	Investigational Site Number 158001	Taipei
Tunisia	Investigational Site Number 788004	Sfax
Tunisia	Investigational Site Number 788003	Sousse
Tunisia	Investigational Site Number 788002	Tunis
Turkey	Investigational Site Number 792003	Antalya
Turkey	Investigational Site Number 792001	Bornova
Turkey	Investigational Site Number 792002	Istanbul
United Kingdom	Investigational Site Number 826002	Birmingham
United Kingdom	Investigational Site Number 826004	Colchester
United Kingdom	Investigational Site Number 826005	Glasgow
United Kingdom	Investigational Site Number 826006	Guildford
United Kingdom	Investigational Site Number 826007	Manchester
United Kingdom	Investigational Site Number 826003	Newcastle Upon Tyne
United Kingdom	Investigational Site Number 826001	Sutton
United States	Investigational Site Number 840020	Akron	Ohio
United States	Investigational Site Number 840008	Anaheim	California
United States	Investigational Site Number 840014	Baltimore	Maryland
United States	Investigational Site Number 840025	Chattanooga	Tennessee
United States	Investigational Site Number 840012	Corpus Christi	Texas
United States	Investigational Site Number 840015	East Orange	New Jersey
United States	Investigational Site Number 840004	Hot Springs	Arkansas
United States	Investigational Site Number 840011	Jackson	Mississippi
United States	Investigational Site Number 840023	Jacksonville	Florida
United States	Investigational Site Number 840010	La Jolla	California
United States	Investigational Site Number 840013	Lakeland	Florida
United States	Investigational Site Number 840016	Lincoln	Nebraska
United States	Investigational Site Number 840002	Muscle Shoals	Alabama
United States	Investigational Site Number 840007	New Orleans	Louisiana
United States	Investigational Site Number 840006	Pawtucket	Rhode Island
United States	Investigational Site Number 840003	Port St. Lucie	Florida
United States	Investigational Site Number 840024	Raleigh	North Carolina
United States	Investigational Site Number 840005	Rockville	Maryland
United States	Investigational Site Number 840001	San Bernardino	California
United States	Investigational Site Number 840017	St Louis Park	Minnesota
United States	Investigational Site Number 840021	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  France,  Germany,  Hungary,  Korea, Republic of,  Netherlands,  Peru,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Tunisia,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		up to 6 years	No
Secondary	Progression Free Survival (PFS)		up to 6 years	No