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Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer (FIRSTANA)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Cabazitaxel (XRP6258)

Docetaxel (XRP6976)

Prednisone

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. Histologically- or cytologically-confirmed prostate adenocarcinoma.
I 02. Metastatic disease.
I 03. Progressive disease while receiving hormonal therapy or after surgical castration.
I 04. Effective castration (serum testosterone levels ≤0.50 ng/mL) by orchiectomy and/or luteinizing hormone-releasing hormone (LHRH) agonists or antagonist with or without anti-androgens.

Exclusion criteria:

E 01. Prior chemotherapy for prostate cancer,
E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Participants on biphosphonates prior to study entry.
E 03. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
E 04. 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 05. Less than 18 years (or country's legal age of majority if the legal age is >18 years).
E 06. Eastern Cooperative Oncology Group (ECOG) performance status >2.
E 07. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
E 08. Prior malignancy.
E 09. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
E 10. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack.
E 11. Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
E 12. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
E 13. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or interfere with interpretation of study results, or participants unable to comply with the study procedures.
E 14. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study.
E 15. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period.
E 16. History of hypersensitivity to docetaxel, or polysorbate 80.
E 17. Inadequate organ and bone marrow function
E 18. Contraindications to the use of corticosteroid treatment.
E 19. Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria [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 3

Arm Type

Experimental

Active Comparator

Arm Label

Cabazitaxel 25 mg/m^2

Cabazitaxel 20 mg/m^2

Docetaxel 75 mg/m^2

Arm Description

Cabazitaxel 25 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.

Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

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 the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.

Secondary Outcome Measures

Progression Free Survival (PFS)

PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.

Time to Tumor Progression Free Survival

Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.

Percentage of Participants With Overall Objective Tumor Response

Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. 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 have 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 Prostate Serum Antigen Progression Free Survival (PSA-PFS)

Time to PSA-PFS: time interval between date of randomization & first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA <10 ng/mL):(a)in participants with baseline PSA>0 ng/mL&<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis 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 Free Survival (Pain PFS)

Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain 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. Analgesic score 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 analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. 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. Analgesic score 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.

Skeletal Related Events (SRE) Free Survival

SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)

FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted 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 was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms.

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

FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted 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). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.

Full Information

NCT ID

NCT01308567

First Posted

March 3, 2011

Last Updated

May 21, 2019

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01308567

Brief Title

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

Acronym

FIRSTANA

Official Title

Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 5, 2011 (Actual)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

May 2018 (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 superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: To evaluate safety in the 3 treatment arms. To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for: Progression Free Survival (PFS) (RECIST 1.1) Tumor progression free survival (RECIST 1.1) Tumor response in participants with measurable disease (RECIST 1.1), PSA response PSA-Progression free survival (PSA-PFS). Pain response in participants with stable pain at baseline Pain progression free survival Time to occurrence of any skeletal related events (SRE) To compare Health-Related Quality of Life (HRQL). To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

Detailed Description

Participants were treated until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. 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 comes 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

1168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cabazitaxel 25 mg/m^2

Arm Type

Experimental

Arm Description

Arm Title

Cabazitaxel 20 mg/m^2

Arm Type

Experimental

Arm Description

Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Arm Title

Docetaxel 75 mg/m^2

Arm Type

Active Comparator

Arm Description

Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Intervention Type

Drug

Intervention Name(s)

Cabazitaxel (XRP6258)

Intervention Description

Pharmaceutical form: Solution for injection; Route of administration: Intravenous

Intervention Type

Drug

Intervention Name(s)

Docetaxel (XRP6976)

Intervention Description

Pharmaceutical form: Solution for injection'; Route of administration: Intravenous

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Pharmaceutical form: Tablet; Route of administration: Oral

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)

Title

Time to Tumor Progression Free Survival

Description

Time Frame

Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Title

Percentage of Participants With Overall Objective Tumor Response

Description

Time Frame

Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Title

Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)

Description

Time Frame

Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 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

Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Title

Time to Pain Progression Free Survival (Pain PFS)

Description

Time Frame

Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)

Title

Percentage of Participants With Pain Response

Description

Time Frame

Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)

Title

Skeletal Related Events (SRE) Free Survival

Description

Time Frame

Baseline until occurrence of first SRE or death (maximum duration: 51 months)

Title

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score 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, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)

Title

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

Description

FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted 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). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.

Time Frame

Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : I 01. Histologically- or cytologically-confirmed prostate adenocarcinoma. I 02. Metastatic disease. I 03. Progressive disease while receiving hormonal therapy or after surgical castration. I 04. Effective castration (serum testosterone levels ≤0.50 ng/mL) by orchiectomy and/or luteinizing hormone-releasing hormone (LHRH) agonists or antagonist with or without anti-androgens. Exclusion criteria: E 01. Prior chemotherapy for prostate cancer, E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Participants on biphosphonates prior to study entry. E 03. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. E 04. 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 05. Less than 18 years (or country's legal age of majority if the legal age is >18 years). E 06. Eastern Cooperative Oncology Group (ECOG) performance status >2. E 07. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease. E 08. Prior malignancy. E 09. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. E 10. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack. E 11. Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event. E 12. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment. E 13. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or interfere with interpretation of study results, or participants unable to comply with the study procedures. E 14. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study. E 15. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period. E 16. History of hypersensitivity to docetaxel, or polysorbate 80. E 17. Inadequate organ and bone marrow function E 18. Contraindications to the use of corticosteroid treatment. E 19. Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria [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 840004

City

Muscle Shoals

State/Province

Alabama

ZIP/Postal Code

35661

Country

United States

Facility Name

Investigational Site Number 840009

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Investigational Site Number 840014

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Investigational Site Number 840030

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Investigational Site Number 840003

City

San Bernardino

State/Province

California

ZIP/Postal Code

92404

Country

United States

Facility Name

Investigational Site Number 840012

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Investigational Site Number 840019

City

Denver

State/Province

Colorado

ZIP/Postal Code

80262

Country

United States

Facility Name

Investigational Site Number 840013

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Investigational Site Number 840035

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Investigational Site Number 840001

City

Port Saint Lucie

State/Province

Florida

ZIP/Postal Code

34952

Country

United States

Facility Name

Investigational Site Number 840015

City

Decatur

State/Province

Illinois

ZIP/Postal Code

62526

Country

United States

Facility Name

Investigational Site Number 840018

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Investigational Site Number 840010

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42002

Country

United States

Facility Name

Investigational Site Number 840008

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Investigational Site Number 840006

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Investigational Site Number 840238

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Investigational Site Number 840138

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Investigational Site Number 840038

City

Brookline

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Investigational Site Number 840005

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Investigational Site Number 840021

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Investigational Site Number 840016

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

Facility Name

Investigational Site Number 840020

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Facility Name

Investigational Site Number 840017

City

East Orange

State/Province

New Jersey

ZIP/Postal Code

07018

Country

United States

Facility Name

Investigational Site Number 840033

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Investigational Site Number 840036

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Investigational Site Number 840011

City

Washington

State/Province

North Carolina

ZIP/Postal Code

27889

Country

United States

Facility Name

Investigational Site Number 840026

City

Akron

State/Province

Ohio

ZIP/Postal Code

44302

Country

United States

Facility Name

Investigational Site Number 840023

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Investigational Site Number 840032

City

Dunmore

State/Province

Pennsylvania

ZIP/Postal Code

18512

Country

United States

Facility Name

Investigational Site Number 840007

City

Pawtucket

State/Province

Rhode Island

ZIP/Postal Code

02860

Country

United States

Facility Name

Investigational Site Number 840037

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

Investigational Site Number 840028

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Investigational Site Number 036016

City

Bankstown

ZIP/Postal Code

2200

Country

Australia

Facility Name

Investigational Site Number 036008

City

Camperdown

ZIP/Postal Code

2050

Country

Australia

Facility Name

Investigational Site Number 036015

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 036017

City

Fitzroy

ZIP/Postal Code

3065

Country

Australia

Facility Name

Investigational Site Number 036003

City

Herston

ZIP/Postal Code

4029

Country

Australia

Facility Name

Investigational Site Number 036010

City

Hornsby

ZIP/Postal Code

2077

Country

Australia

Facility Name

Investigational Site Number 036012

City

Kurralta Park

ZIP/Postal Code

5037

Country

Australia

Facility Name

Investigational Site Number 036002

City

Parkville

ZIP/Postal Code

3050

Country

Australia

Facility Name

Investigational Site Number 036009

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

Investigational Site Number 036011

City

Subiaco

ZIP/Postal Code

6008

Country

Australia

Facility Name

Investigational Site Number 036013

City

Wodonga

ZIP/Postal Code

3690

Country

Australia

Facility Name

Investigational Site Number 112001

City

Minsk

ZIP/Postal Code

220013

Country

Belarus

Facility Name

Investigational Site Number 112002

City

Minsk

ZIP/Postal Code

223040

Country

Belarus

Facility Name

Investigational Site Number 112004

City

Vitebsk

ZIP/Postal Code

210603

Country

Belarus

Facility Name

Investigational Site Number 076006

City

Passo Fundo

ZIP/Postal Code

99010-260

Country

Brazil

Facility Name

Investigational Site Number 076001

City

Porto Alegre

ZIP/Postal Code

90035-001

Country

Brazil

Facility Name

Investigational Site Number 076002

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Investigational Site Number 076004

City

Rio De Janeiro

ZIP/Postal Code

20230-130

Country

Brazil

Facility Name

Investigational Site Number 076009

City

Sao Jose Do Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Investigational Site Number 076005

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Investigational Site Number 076003

City

Uberlandia

ZIP/Postal Code

38408 150

Country

Brazil

Facility Name

Investigational Site Number 124002

City

London

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Investigational Site Number 124007

City

Mississauga

ZIP/Postal Code

L5M 2N1

Country

Canada

Facility Name

Investigational Site Number 124005

City

Moncton

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Investigational Site Number 124003

City

Montreal

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Investigational Site Number 124004

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Investigational Site Number 124006

City

Toronto

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Investigational Site Number 156005

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Investigational Site Number 156002

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Investigational Site Number 156003

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Investigational Site Number 156004

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Investigational Site Number 203002

City

Brno

ZIP/Postal Code

65653

Country

Czechia

Facility Name

Investigational Site Number 203003

City

Novy Jicin

ZIP/Postal Code

74101

Country

Czechia

Facility Name

Investigational Site Number 203001

City

Olomouc

ZIP/Postal Code

77520

Country

Czechia

Facility Name

Investigational Site Number 203004

City

Praha 2

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Investigational Site Number 208002

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Investigational Site Number 208001

City

København Ø

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Investigational Site Number 208003

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Investigational Site Number 208004

City

Ålborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Investigational Site Number 246002

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Investigational Site Number 246001

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Investigational Site Number 246003

City

Turku

ZIP/Postal Code

FIN-20520

Country

Finland

Facility Name

Investigational Site Number 250010

City

Besancon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Investigational Site Number 250002

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Investigational Site Number 250006

City

Caen Cedex 05

ZIP/Postal Code

14076

Country

France

Facility Name

Investigational Site Number 250005

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

Investigational Site Number 250003

City

Paris Cedex 05

ZIP/Postal Code

75231

Country

France

Facility Name

Investigational Site Number 250004

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Investigational Site Number 250001

City

Paris Cedex 15

ZIP/Postal Code

75908

Country

France

Facility Name

Investigational Site Number 250007

City

Poitiers Cedex

ZIP/Postal Code

86021

Country

France

Facility Name

Investigational Site Number 250008

City

Suresnes

ZIP/Postal Code

92151

Country

France

Facility Name

Investigational Site Number 250009

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Investigational Site Number 276003

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Investigational Site Number 276005

City

Berlin

ZIP/Postal Code

14197

Country

Germany

Facility Name

Investigational Site Number 276001

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Investigational Site Number 276004

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Investigational Site Number 276002

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 376004

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Investigational Site Number 376003

City

Petah-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Investigational Site Number 376002

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Investigational Site Number 380001

City

Arezzo

ZIP/Postal Code

06156

Country

Italy

Facility Name

Investigational Site Number 380004

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Investigational Site Number 380003

City

Orbassano

ZIP/Postal Code

10043

Country

Italy

Facility Name

Investigational Site Number 380005

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Investigational Site Number 380002

City

Trento

ZIP/Postal Code

38100

Country

Italy

Facility Name

Investigational Site Number 392001

City

Bunkyo-Ku

Country

Japan

Facility Name

Investigational Site Number 392003

City

Chiba-Shi

Country

Japan

Facility Name

Investigational Site Number 392006

City

Kashiwa-Shi

Country

Japan

Facility Name

Investigational Site Number 392005

City

Koto-Ku

Country

Japan

Facility Name

Investigational Site Number 392002

City

Osaka Sayama-Shi

Country

Japan

Facility Name

Investigational Site Number 392004

City

Osaka-Shi

Country

Japan

Facility Name

Investigational Site Number 484007

City

Acapulco

ZIP/Postal Code

39670

Country

Mexico

Facility Name

Investigational Site Number 484008

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Investigational Site Number 484003

City

D.f.

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Investigational Site Number 484004

City

Guadalajara

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Investigational Site Number 484009

City

Merida

ZIP/Postal Code

97134

Country

Mexico

Facility Name

Investigational Site Number 484005

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Investigational Site Number 484002

City

San Luis Potosi

Country

Mexico

Facility Name

Investigational Site Number 484006

City

Zapopan

ZIP/Postal Code

45040

Country

Mexico

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 604005

City

Lima

ZIP/Postal Code

LIMA 01

Country

Peru

Facility Name

Investigational Site Number 604002

City

Lima

ZIP/Postal Code

LIMA 34

Country

Peru

Facility Name

Investigational Site Number 616002

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Investigational Site Number 616001

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Investigational Site Number 616003

City

Koscierzyna

ZIP/Postal Code

83-400

Country

Poland

Facility Name

Investigational Site Number 616005

City

Lodz

ZIP/Postal Code

93-509

Country

Poland

Facility Name

Investigational Site Number 616004

City

Poznan

ZIP/Postal Code

61-485

Country

Poland

Facility Name

Investigational Site Number 620003

City

Coimbra

ZIP/Postal Code

3049

Country

Portugal

Facility Name

Investigational Site Number 620005

City

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

Investigational Site Number 620004

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Investigational Site Number 620001

City

Porto

ZIP/Postal Code

4200

Country

Portugal

Facility Name

Investigational Site Number 620002

City

Porto

ZIP/Postal Code

4200

Country

Portugal

Facility Name

Investigational Site Number 642004

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Investigational Site Number 642008

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

Investigational Site Number 642005

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Investigational Site Number 642002

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 642007

City

Hunedoara

ZIP/Postal Code

331057

Country

Romania

Facility Name

Investigational Site Number 643004

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Investigational Site Number 643008

City

Moscow

ZIP/Postal Code

129128

Country

Russian Federation

Facility Name

Investigational Site Number 643003

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Investigational Site Number 643002

City

Pyatigorsk

ZIP/Postal Code

357502

Country

Russian Federation

Facility Name

Investigational Site Number 643007

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Investigational Site Number 643005

City

St-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Investigational Site Number 643001

City

Tomsk

ZIP/Postal Code

634028

Country

Russian Federation

Facility Name

Investigational Site Number 643006

City

Yaroslavl

ZIP/Postal Code

150054

Country

Russian Federation

Facility Name

Investigational Site Number 724001

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Investigational Site Number 724007

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Investigational Site Number 724002

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Investigational Site Number 724003

City

Hospitalet De Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Investigational Site Number 724005

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Investigational Site Number 724004

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Investigational Site Number 724006

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Investigational Site Number 752003

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Investigational Site Number 752002

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Investigational Site Number 752001

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Investigational Site Number 158004

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Investigational Site Number 158002

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

Investigational Site Number 158001

City

Taipei

Country

Taiwan

Facility Name

Investigational Site Number 158003

City

Tao-Yuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Investigational Site Number 792002

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Investigational Site Number 792001

City

Istanbul

ZIP/Postal Code

34303

Country

Turkey

Facility Name

Investigational Site Number 804009

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Investigational Site Number 804004

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Investigational Site Number 804010

City

Donetsk

ZIP/Postal Code

83092

Country

Ukraine

Facility Name

Investigational Site Number 804006

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Investigational Site Number 804003

City

Kharkov

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

Investigational Site Number 804002

City

Kyiv

ZIP/Postal Code

01133

Country

Ukraine

Facility Name

Investigational Site Number 804001

City

Kyiv

ZIP/Postal Code

1601

Country

Ukraine

Facility Name

Investigational Site Number 804007

City

Lutsk

ZIP/Postal Code

43018

Country

Ukraine

Facility Name

Investigational Site Number 804005

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Investigational Site Number 804008

City

Zaporizhzhya

ZIP/Postal Code

69040

Country

Ukraine

12. IPD Sharing Statement

Citations:

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

28753384

Citation

Oudard S, Fizazi K, Sengelov L, Daugaard G, Saad F, Hansen S, Hjalm-Eriksson M, Jassem J, Thiery-Vuillemin A, Caffo O, Castellano D, Mainwaring PN, Bernard J, Shen L, Chadjaa M, Sartor O. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA. J Clin Oncol. 2017 Oct 1;35(28):3189-3197. doi: 10.1200/JCO.2016.72.1068. Epub 2017 Jul 28.

Results Reference

derived

PubMed Identifier

24722180

Citation

de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

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 Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

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Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer (FIRSTANA)

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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