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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)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Cabazitaxel (XRP6258)

Prednisone (or Prednisolone)

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria :

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

I 02. Participant must had 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. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours).

I 06. Age ≥18 years (or country's legal age of majority if the legal age was > 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 had 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 were allowed, as well as any other cancer for which chemotherapy had been completed ≥ 5 years ago and from which the participant had 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 was also not allowed.

E 10. Any severe acute or chronic medical condition which could impair the ability of the participant 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 participant informed consent form prior to enrollment into the study.

E 12. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" was based on the Investigator's judgment. Participant's Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason had 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 (NCI CTCAE v.4.03).

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cabazitaxel 20 mg/m^2

Cabazitaxel 25 mg/m^2

Arm Description

Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.

Secondary Outcome Measures

Progression Free Survival (PFS)

PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method.

Time to Tumor Progression

Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method.

Percentage of Participants With Overall Objective Tumor Response

Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time to PSA Progression

Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.

Percentage of Participants With PSA Response

PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.

Time to Pain Progression

Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.

Percentage of Participants With Pain Response

Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response.

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.

Change From Baseline in FACT-P:Total Score as a Measure of HRQoL

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.

Percentage of Participants With FACT-P Total Score Response

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.

Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales

The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.

Time to Definitive Deterioration of ECOG PS Score From Baseline

The ECOG PS was used to evaluate participant's DP and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method.

Time to Definitive Weight Loss by 5% and 10% From Baseline

Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method.

Time to First Definitive Consumption of Narcotic Medication

Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method.

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs.

Plasma Clearance (CL) for Cabazitaxel

Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.

Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel

Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.

Full Information

NCT ID

NCT01308580

First Posted

March 3, 2011

Last Updated

March 16, 2017

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01308580

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 participants 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 was 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), prostate-specific antigen (PSA) progression, pain progression or death due to any cause; PSA Progression; Pain progression; Tumor response in participants with measurable disease (RECIST 1.1); PSA response; Pain response in participants with stable pain at baseline. To compare Health-related Quality of Life (HRQoL). To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.

Detailed Description

Participants were treated until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever came first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cabazitaxel 20 mg/m^2

Arm Type

Experimental

Arm Description

Arm Title

Cabazitaxel 25 mg/m^2

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cabazitaxel (XRP6258)

Other Intervention Name(s)

Jevtana®

Intervention Description

Pharmaceutical form: Concentrate and solvent for solution for infusion Route of administration: Intravenous

Intervention Type

Drug

Intervention Name(s)

Prednisone (or Prednisolone)

Intervention Description

Pharmaceutical form: Tablet Route of administration: Oral

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Title

Time to Tumor Progression

Description

Time Frame

From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Title

Percentage of Participants With Overall Objective Tumor Response

Description

Time Frame

From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Title

Time to PSA Progression

Description

Time Frame

From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Title

Percentage of Participants With PSA Response

Description

PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.

Time Frame

From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Title

Time to Pain Progression

Description

Time Frame

From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Title

Percentage of Participants With Pain Response

Description

Time Frame

From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)

Description

Time Frame

Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)

Title

Change From Baseline in FACT-P:Total Score as a Measure of HRQoL

Description

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.

Time Frame

Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)

Title

Percentage of Participants With FACT-P Total Score Response

Description

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.

Time Frame

From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Title

Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales

Description

Time Frame

From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Title

Time to Definitive Deterioration of ECOG PS Score From Baseline

Description

Time Frame

From baseline until death or study cut-off date (maximum duration: 48 months)

Title

Time to Definitive Weight Loss by 5% and 10% From Baseline

Description

Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method.

Time Frame

From baseline until death or study cut-off date (maximum duration: 48 months)

Title

Time to First Definitive Consumption of Narcotic Medication

Description

Time Frame

From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Title

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)

Title

Plasma Clearance (CL) for Cabazitaxel

Description

Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.

Time Frame

Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI

Title

Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel

Description

Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.

Time Frame

Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was resistant to hormone therapy and previously treated with a docetaxel-containing regimen. I 02. Participant must had 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. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours). I 06. Age ≥18 years (or country's legal age of majority if the legal age was > 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 had 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 were allowed, as well as any other cancer for which chemotherapy had been completed ≥ 5 years ago and from which the participant had 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 was also not allowed. E 10. Any severe acute or chronic medical condition which could impair the ability of the participant 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 participant informed consent form prior to enrollment into the study. E 12. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" was based on the Investigator's judgment. Participant's Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason had 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 (NCI CTCAE v.4.03). The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840002

City

Muscle Shoals

State/Province

Alabama

ZIP/Postal Code

35661

Country

United States

Facility Name

Investigational Site Number 840004

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Investigational Site Number 840008

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Investigational Site Number 840010

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Investigational Site Number 840001

City

San Bernardino

State/Province

California

ZIP/Postal Code

92404

Country

United States

Facility Name

Investigational Site Number 840021

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Name

Investigational Site Number 840023

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Investigational Site Number 840013

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

Investigational Site Number 840003

City

Port St. Lucie

State/Province

Florida

ZIP/Postal Code

34952

Country

United States

Facility Name

Investigational Site Number 840007

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Investigational Site Number 840014

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Investigational Site Number 840005

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Investigational Site Number 840017

City

St Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Investigational Site Number 840011

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Investigational Site Number 840016

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Facility Name

Investigational Site Number 840015

City

East Orange

State/Province

New Jersey

ZIP/Postal Code

07018

Country

United States

Facility Name

Investigational Site Number 840024

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Investigational Site Number 840020

City

Akron

State/Province

Ohio

ZIP/Postal Code

44302

Country

United States

Facility Name

Investigational Site Number 840006

City

Pawtucket

State/Province

Rhode Island

ZIP/Postal Code

02860

Country

United States

Facility Name

Investigational Site Number 840025

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Investigational Site Number 840012

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78405

Country

United States

Facility Name

Investigational Site Number 032002

City

Buenos Aires

ZIP/Postal Code

C1120AAT

Country

Argentina

Facility Name

Investigational Site Number 032001

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Investigational Site Number 032003

City

Salta

ZIP/Postal Code

A4406CLA

Country

Argentina

Facility Name

Investigational Site Number 032004

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Investigational Site Number 036014

City

Adelaide

ZIP/Postal Code

5000

Country

Australia

Facility Name

Investigational Site Number 036013

City

Bankstown

ZIP/Postal Code

2200

Country

Australia

Facility Name

Investigational Site Number 036010

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Investigational Site Number 036012

City

Camperdown

ZIP/Postal Code

2050

Country

Australia

Facility Name

Investigational Site Number 036008

City

Coffs Harbour

ZIP/Postal Code

2450

Country

Australia

Facility Name

Investigational Site Number 036001

City

Concord

ZIP/Postal Code

2137

Country

Australia

Facility Name

Investigational Site Number 036015

City

Elizabeth Vale

ZIP/Postal Code

5112

Country

Australia

Facility Name

Investigational Site Number 036009

City

Fitzroy

ZIP/Postal Code

3065

Country

Australia

Facility Name

Investigational Site Number 036007

City

Garran

ZIP/Postal Code

2605

Country

Australia

Facility Name

Investigational Site Number 036005

City

Heidelberg West

ZIP/Postal Code

3081

Country

Australia

Facility Name

Investigational Site Number 036002

City

Malvern

ZIP/Postal Code

3144

Country

Australia

Facility Name

Investigational Site Number 036006

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

Investigational Site Number 036016

City

Subiaco

ZIP/Postal Code

6008

Country

Australia

Facility Name

Investigational Site Number 036003

City

Wahroonga

ZIP/Postal Code

2076

Country

Australia

Facility Name

Investigational Site Number 036004

City

Wodonga

ZIP/Postal Code

3690

Country

Australia

Facility Name

Investigational Site Number 056007

City

Antwerpen

ZIP/Postal Code

B-2020

Country

Belgium

Facility Name

Investigational Site Number 056008

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Investigational Site Number 056001

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Investigational Site Number 056002

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Investigational Site Number 056009

City

Charleroi

ZIP/Postal Code

B-6000

Country

Belgium

Facility Name

Investigational Site Number 056003

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Investigational Site Number 056012

City

Godinne

ZIP/Postal Code

B-5530

Country

Belgium

Facility Name

Investigational Site Number 056016

City

Haine-Saint-Paul

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Investigational Site Number 056005

City

Hasselt

ZIP/Postal Code

B-3500

Country

Belgium

Facility Name

Investigational Site Number 056010

City

Libramont

ZIP/Postal Code

6800

Country

Belgium

Facility Name

Investigational Site Number 056013

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Investigational Site Number 056011

City

Ottignies

ZIP/Postal Code

1340

Country

Belgium

Facility Name

Investigational Site Number 056004

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Investigational Site Number 056006

City

Turnhout

ZIP/Postal Code

B-2300

Country

Belgium

Facility Name

Investigational Site Number 076016

City

Fortaleza

Country

Brazil

Facility Name

Investigational Site Number 076012

City

Ijui

ZIP/Postal Code

98700 000

Country

Brazil

Facility Name

Investigational Site Number 076015

City

Mogi Das Cruzes

ZIP/Postal Code

08730-500

Country

Brazil

Facility Name

Investigational Site Number 076014

City

Porto Alegre

ZIP/Postal Code

90110-270

Country

Brazil

Facility Name

Investigational Site Number 076010

City

Rio De Janeiro

ZIP/Postal Code

22793-080

Country

Brazil

Facility Name

Investigational Site Number 076007

City

Salvador

ZIP/Postal Code

41256-900

Country

Brazil

Facility Name

Investigational Site Number 076003

City

Sao Jose Do Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Investigational Site Number 076009

City

Sao Paulo

ZIP/Postal Code

01221-020

Country

Brazil

Facility Name

Investigational Site Number 076001

City

Sao Paulo

ZIP/Postal Code

01308050

Country

Brazil

Facility Name

Investigational Site Number 076013

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Facility Name

Investigational Site Number 076008

City

Sao Paulo

ZIP/Postal Code

01509-900

Country

Brazil

Facility Name

Investigational Site Number 076002

City

Sao Paulo

ZIP/Postal Code

03102-002

Country

Brazil

Facility Name

Investigational Site Number 124002

City

Greenfield Park

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Investigational Site Number 124001

City

Oshawa

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Investigational Site Number 124003

City

Ottawa

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Investigational Site Number 124005

City

Owen Sound

ZIP/Postal Code

N4K 2J1

Country

Canada

Facility Name

Investigational Site Number 152005

City

Santiago

ZIP/Postal Code

751-0009

Country

Chile

Facility Name

Investigational Site Number 152004

City

Santiago

ZIP/Postal Code

7510032

Country

Chile

Facility Name

Investigational Site Number 152002

City

Santiago

ZIP/Postal Code

8380456

Country

Chile

Facility Name

Investigational Site Number 152001

City

Viña Del Mar

ZIP/Postal Code

2540364

Country

Chile

Facility Name

Investigational Site Number 250005

City

Avignon Cedex 9

ZIP/Postal Code

84918

Country

France

Facility Name

Investigational Site Number 250008

City

Hyeres

ZIP/Postal Code

83400

Country

France

Facility Name

Investigational Site Number 250001

City

La Roche Sur Yon

ZIP/Postal Code

85925

Country

France

Facility Name

Investigational Site Number 250002

City

Nantes Cedex 2

ZIP/Postal Code

44202

Country

France

Facility Name

Investigational Site Number 250004

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Investigational Site Number 250010

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Investigational Site Number 250009

City

Reims Cedex

ZIP/Postal Code

51056

Country

France

Facility Name

Investigational Site Number 250007

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Investigational Site Number 250006

City

Saint Brieuc Cedex

ZIP/Postal Code

22015

Country

France

Facility Name

Investigational Site Number 250011

City

Toulouse Cedex 03

ZIP/Postal Code

31076

Country

France

Facility Name

Investigational Site Number 250003

City

Toulouse Cedex 09

ZIP/Postal Code

31052

Country

France

Facility Name

Investigational Site Number 276003

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Investigational Site Number 276007

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Investigational Site Number 276004

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Investigational Site Number 276001

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Investigational Site Number 276011

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Investigational Site Number 276005

City

Hamburg

ZIP/Postal Code

22399

Country

Germany

Facility Name

Investigational Site Number 276010

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Investigational Site Number 276006

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Investigational Site Number 276012

City

Nürtingen

ZIP/Postal Code

72622

Country

Germany

Facility Name

Investigational Site Number 276008

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Investigational Site Number 276002

City

Wuppertal

ZIP/Postal Code

42103

Country

Germany

Facility Name

Investigational Site Number 348001

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Investigational Site Number 348005

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Investigational Site Number 348004

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Investigational Site Number 348006

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Investigational Site Number 348003

City

Pécs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Investigational Site Number 410003

City

Seongnam

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

Investigational Site Number 410002

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Investigational Site Number 410004

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Investigational Site Number 410005

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Investigational Site Number 410001

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Investigational Site Number 528005

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Investigational Site Number 528003

City

Blaricum

ZIP/Postal Code

1261 AN

Country

Netherlands

Facility Name

Investigational Site Number 528004

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

Investigational Site Number 528002

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Investigational Site Number 528001

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Investigational Site Number 604003

City

Arequipa

ZIP/Postal Code

5154

Country

Peru

Facility Name

Investigational Site Number 604006

City

Lima

ZIP/Postal Code

027

Country

Peru

Facility Name

Investigational Site Number 604001

City

Lima

ZIP/Postal Code

041

Country

Peru

Facility Name

Investigational Site Number 604007

City

Lima

ZIP/Postal Code

LIM27

Country

Peru

Facility Name

Investigational Site Number 604002

City

Lima

ZIP/Postal Code

Lima -41

Country

Peru

Facility Name

Investigational Site Number 604004

City

Lima

ZIP/Postal Code

LIMA 01

Country

Peru

Facility Name

Investigational Site Number 604005

City

Lima

ZIP/Postal Code

Lima 41

Country

Peru

Facility Name

Investigational Site Number 616006

City

Lubin

ZIP/Postal Code

59-300

Country

Poland

Facility Name

Investigational Site Number 616002

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

Investigational Site Number 616001

City

Rybnik

ZIP/Postal Code

44-200

Country

Poland

Facility Name

Investigational Site Number 616005

City

Siedlce

ZIP/Postal Code

08-110

Country

Poland

Facility Name

Investigational Site Number 616004

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Investigational Site Number 642005

City

Alba Iulia

ZIP/Postal Code

510077

Country

Romania

Facility Name

Investigational Site Number 642006

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Investigational Site Number 642009

City

Bucuresti

ZIP/Postal Code

010976

Country

Romania

Facility Name

Investigational Site Number 642008

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Investigational Site Number 642001

City

Cluj Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Investigational Site Number 642003

City

Cluj Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Investigational Site Number 642004

City

Cluj Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Investigational Site Number 642002

City

Cluj Napoca

ZIP/Postal Code

400058

Country

Romania

Facility Name

Investigational Site Number 642012

City

Focsani

ZIP/Postal Code

620034

Country

Romania

Facility Name

Investigational Site Number 642007

City

Hunedoara

ZIP/Postal Code

331057

Country

Romania

Facility Name

Investigational Site Number 642013

City

Onesti

ZIP/Postal Code

601048

Country

Romania

Facility Name

Investigational Site Number 643009

City

Ekaterinburg

ZIP/Postal Code

620036

Country

Russian Federation

Facility Name

Investigational Site Number 643007

City

Moscow

ZIP/Postal Code

105425

Country

Russian Federation

Facility Name

Investigational Site Number 643005

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Investigational Site Number 643004

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Investigational Site Number 643006

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Investigational Site Number 643008

City

Obninsk

ZIP/Postal Code

249036

Country

Russian Federation

Facility Name

Investigational Site Number 643001

City

St.Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Investigational Site Number 643010

City

St.Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Investigational Site Number 643003

City

Tula

ZIP/Postal Code

300053

Country

Russian Federation

Facility Name

Investigational Site Number 710003

City

Cape Town

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Investigational Site Number 710002

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Investigational Site Number 710005

City

Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Investigational Site Number 710004

City

Johannesburg

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Investigational Site Number 710001

City

Pretoria

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Investigational Site Number 724003

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Investigational Site Number 724001

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number 724002

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Investigational Site Number 724008

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Investigational Site Number 724006

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Investigational Site Number 724005

City

Palma De Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

Investigational Site Number 724004

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number 724007

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Investigational Site Number 158002

City

Taiching

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Investigational Site Number 158003

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Investigational Site Number 158001

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Investigational Site Number 788004

City

Sfax

ZIP/Postal Code

3029

Country

Tunisia

Facility Name

Investigational Site Number 788003

City

Sousse

ZIP/Postal Code

4000

Country

Tunisia

Facility Name

Investigational Site Number 788002

City

Tunis

ZIP/Postal Code

1006

Country

Tunisia

Facility Name

Investigational Site Number 792003

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Facility Name

Investigational Site Number 792001

City

Bornova

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Investigational Site Number 792002

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Investigational Site Number 826002

City

Birmingham

ZIP/Postal Code

B18 7QH

Country

United Kingdom

Facility Name

Investigational Site Number 826004

City

Colchester

ZIP/Postal Code

CO3 3NB

Country

United Kingdom

Facility Name

Investigational Site Number 826005

City

Glasgow

ZIP/Postal Code

G11 6NT

Country

United Kingdom

Facility Name

Investigational Site Number 826006

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Investigational Site Number 826007

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Investigational Site Number 826003

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Investigational Site Number 826001

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35677318

Citation

Meisel A, de Wit R, Oudard S, Sartor O, Stenner-Liewen F, Shun Z, Foster M, Ozatilgan A, Eisenberger M, de Bono JS. Neutropenia, neutrophilia, and neutrophil-lymphocyte ratio as prognostic markers in patients with metastatic castration-resistant prostate cancer. Ther Adv Med Oncol. 2022 Jun 1;14:17588359221100022. doi: 10.1177/17588359221100022. eCollection 2022.

Results Reference

derived

PubMed Identifier

33740734

Citation

Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.

Results Reference

derived

PubMed Identifier

29500065

Citation

Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Mace S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.

Results Reference

derived

PubMed Identifier

28809610

Citation

Eisenberger M, Hardy-Bessard AC, Kim CS, Geczi L, Ford D, Mourey L, Carles J, Parente P, Font A, Kacso G, Chadjaa M, Zhang W, Bernard J, de Bono J. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017 Oct 1;35(28):3198-3206. doi: 10.1200/JCO.2016.72.1076. Epub 2017 Aug 15.

Results Reference

derived

PubMed Identifier

23228299

Citation

Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91. No abstract available.

Results Reference

derived

Learn more about this trial

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

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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)

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial