AzTrials
AzTrials

Prostate CancerPhase 3FIRSTANANCT01308567

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

A Phase 3 study testing Cabazitaxel (XRP6258), Docetaxel (XRP6976) and Prednisone in people with Prostate Cancer, run by Sanofi at 167 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Cabazitaxel (XRP6258), Docetaxel (XRP6976) and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,168 participants
Where
167 sitesin 25 countries
Study dates
5 May 2011to May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

167 sites in 25 countries.

167 sites in 25 countries

United States32 sites

  • Investigational Site Number 840026

    Akron, Ohio, 44302

  • Investigational Site Number 840033

    Albuquerque, New Mexico, 87109

  • Investigational Site Number 840009

    Anaheim, California, 92801

  • Investigational Site Number 840014

    Bakersfield, California, 93309

  • Investigational Site Number 840013

    Boca Raton, Florida, 33486

  • Investigational Site Number 840238

    Boston, Massachusetts, 02114

  • Investigational Site Number 840138

    Boston, Massachusetts, 02115

  • Investigational Site Number 840038

    Brookline, Massachusetts, 02115

  • Investigational Site Number 840028

    Chattanooga, Tennessee, 37421

  • Investigational Site Number 840023

    Cleveland, Ohio, 44106

  • Investigational Site Number 840015

    Decatur, Illinois, 62526

  • Investigational Site Number 840019

    Denver, Colorado, 80262

  • Investigational Site Number 840005

    Detroit, Michigan, 48202

  • Investigational Site Number 840032

    Dunmore, Pennsylvania, 18512

  • Investigational Site Number 840017

    East Orange, New Jersey, 07018

  • Investigational Site Number 840035

    Jacksonville, Florida, 32256

  • Investigational Site Number 840016

    Kansas City, Missouri, 64128

  • Investigational Site Number 840020

    Lincoln, Nebraska, 68506

  • Investigational Site Number 840004

    Muscle Shoals, Alabama, 35661

  • Investigational Site Number 840037

    Myrtle Beach, South Carolina, 29572

  • Investigational Site Number 840008

    New Orleans, Louisiana, 70112

  • Investigational Site Number 840010

    Paducah, Kentucky, 42002

  • Investigational Site Number 840007

    Pawtucket, Rhode Island, 02860

  • Investigational Site Number 840001

    Port Saint Lucie, Florida, 34952

  • Investigational Site Number 840036

    Raleigh, North Carolina, 27607

  • Investigational Site Number 840006

    Rockville, Maryland, 20850

  • Investigational Site Number 840030

    Sacramento, California, 95816

  • Investigational Site Number 840021

    Saint Louis Park, Minnesota, 55416

  • Investigational Site Number 840003

    San Bernardino, California, 92404

  • Investigational Site Number 840012

    San Francisco, California, 94143

  • Investigational Site Number 840011

    Washington, North Carolina, 27889

  • Investigational Site Number 840018

    Wichita, Kansas, 67214

Other trials in United States

Australia12 sites

  • Investigational Site Number 036016

    Bankstown, 2200

  • Investigational Site Number 036008

    Camperdown, 2050

  • Investigational Site Number 036015

    Coffs Harbour, 2450

  • Investigational Site Number 036001

    Concord, 2137

  • Investigational Site Number 036017

    Fitzroy, 3065

  • Investigational Site Number 036003

    Herston, 4029

  • Investigational Site Number 036010

    Hornsby, 2077

  • Investigational Site Number 036012

    Kurralta Park, 5037

  • Investigational Site Number 036002

    Parkville, 3050

  • Investigational Site Number 036009

    South Brisbane, 4101

  • Investigational Site Number 036011

    Subiaco, 6008

  • Investigational Site Number 036013

    Wodonga, 3690

Other trials in Australia

France10 sites

  • Investigational Site Number 250010

    Besançon, 25030

  • Investigational Site Number 250002

    Bordeaux, 33076

  • Investigational Site Number 250006

    Caen, 14076

  • Investigational Site Number 250005

    Lyon, 69373

  • Investigational Site Number 250003

    Paris, 75231

  • Investigational Site Number 250004

    Paris, 75475

  • Investigational Site Number 250001

    Paris, 75908

  • Investigational Site Number 250007

    Poitiers, 86021

  • Investigational Site Number 250008

    Suresnes, 92151

  • Investigational Site Number 250009

    Villejuif, 94805

Other trials in France

Ukraine10 sites

  • Investigational Site Number 804009

    Cherkasy, 18009

  • Investigational Site Number 804004

    Dnipropetrovsk, 49102

  • Investigational Site Number 804010

    Donetsk, 83092

  • Investigational Site Number 804006

    Ivano-Frankivsk, 76018

  • Investigational Site Number 804003

    Kharkiv, 61037

  • Investigational Site Number 804002

    Kyiv, 01133

  • Investigational Site Number 804001

    Kyiv, 1601

  • Investigational Site Number 804007

    Lutsk, 43018

  • Investigational Site Number 804005

    Uzhhorod, 88000

  • Investigational Site Number 804008

    Zaporizhzhya, 69040

Other trials in Ukraine

Mexico8 sites

  • Investigational Site Number 484007

    Acapulco, 39670

  • Investigational Site Number 484008

    Aguascalientes, 20230

  • Investigational Site Number 484003

    D.F., 14080

  • Investigational Site Number 484004

    Guadalajara, 44280

  • Investigational Site Number 484009

    Mérida, 97134

  • Investigational Site Number 484005

    Querétaro, 76000

  • Investigational Site Number 484002

    San Luis Potosí City

  • Investigational Site Number 484006

    Zapopan, 45040

Other trials in Mexico

Russia8 sites

  • Investigational Site Number 643008

    Moscow, 129128

  • Investigational Site Number 643003

    Omsk, 644013

  • Investigational Site Number 643002

    Pyatigorsk, 357502

  • Investigational Site Number 643007

    Ryazan, 390011

  • Investigational Site Number 643005

    Saint Petersburg, 197758

  • Investigational Site Number 643001

    Tomsk, 634028

  • Investigational Site Number 643006

    Yaroslavl, 150054

  • Investigational Site Number 643004

    Yekaterinburg, 620102

Other trials in Russia

Brazil7 sites

  • Investigational Site Number 076006

    Passo Fundo, 99010-260

  • Investigational Site Number 076001

    Porto Alegre, 90035-001

  • Investigational Site Number 076002

    Porto Alegre, 90610-000

  • Investigational Site Number 076004

    Rio de Janeiro, 20230-130

  • Investigational Site Number 076009

    São José do Rio Preto, 15090-000

  • Investigational Site Number 076005

    São Paulo, 01246-000

  • Investigational Site Number 076003

    Uberlândia, 38408 150

Other trials in Brazil

Spain7 sites

  • Investigational Site Number 724001

    Barcelona, 08003

  • Investigational Site Number 724007

    Barcelona, 08025

  • Investigational Site Number 724002

    Barcelona, 08036

  • Investigational Site Number 724003

    L'Hospitalet de Llobregat, 08907

  • Investigational Site Number 724005

    Madrid, 28007

  • Investigational Site Number 724004

    Madrid, 28041

  • Investigational Site Number 724006

    Santiago de Compostela, 15706

Other trials in Spain

Canada6 sites

  • Investigational Site Number 124002

    London, N6A 4L6

  • Investigational Site Number 124007

    Mississauga, L5M 2N1

  • Investigational Site Number 124005

    Moncton, E1C 6Z8

  • Investigational Site Number 124003

    Montreal, H2L 4M1

  • Investigational Site Number 124004

    Québec, G1R 2J6

  • Investigational Site Number 124006

    Toronto, M4N 3M5

Other trials in Canada

Germany6 sites

  • Investigational Site Number 276003

    Aachen, 52074

  • Investigational Site Number 276005

    Berlin, 14197

  • Investigational Site Number 276001

    Düsseldorf, 40225

  • Investigational Site Number 276004

    Erlangen, 91054

  • Investigational Site Number 276002

    Homburg, 66421

  • Investigational Site Number 276006

    München, 81675

Other trials in Germany

Japan6 sites

  • Investigational Site Number 392001

    Bunkyō City

  • Investigational Site Number 392003

    Chiba

  • Investigational Site Number 392006

    Kashiwa-Shi

  • Investigational Site Number 392005

    Kōtoku

  • Investigational Site Number 392004

    Osaka

  • Investigational Site Number 392002

    Osaka Sayama-Shi

Other trials in Japan

Romania6 sites

  • Investigational Site Number 642004

    Baia Mare, 430031

  • Investigational Site Number 642005

    Bucharest, 022328

  • Investigational Site Number 642008

    Bucharest, 022328

  • Investigational Site Number 642002

    Cluj-Napoca, 400015

  • Investigational Site Number 642003

    Cluj-Napoca, 400015

  • Investigational Site Number 642007

    Hunedoara, 331057

Other trials in Romania

Italy5 sites

  • Investigational Site Number 380001

    Arezzo, 06156

  • Investigational Site Number 380004

    Bari, 70124

  • Investigational Site Number 380003

    Orbassano, 10043

  • Investigational Site Number 380005

    Roma, 00144

  • Investigational Site Number 380002

    Trento, 38100

Other trials in Italy

Poland5 sites

  • Investigational Site Number 616002

    Bydgoszcz, 85-796

  • Investigational Site Number 616001

    Gdansk, 80-952

  • Investigational Site Number 616003

    Kościerzyna, 83-400

  • Investigational Site Number 616005

    Lodz, 93-509

  • Investigational Site Number 616004

    Poznan, 61-485

Other trials in Poland

Portugal5 sites

  • Investigational Site Number 620003

    Coimbra, 3049

  • Investigational Site Number 620005

    Lisbon, 1099-023

  • Investigational Site Number 620004

    Lisbon, 1649-035

  • Investigational Site Number 620001

    Porto, 4200

  • Investigational Site Number 620002

    Porto, 4200

Other trials in Portugal

China4 sites

  • Investigational Site Number 156005

    Beijing, 100034

  • Investigational Site Number 156002

    Shanghai, 200032

  • Investigational Site Number 156003

    Shanghai, 200040

  • Investigational Site Number 156004

    Shanghai, 200040

Other trials in China

Czechia4 sites

  • Investigational Site Number 203002

    Brno, 65653

  • Investigational Site Number 203003

    Nový Jičín, 74101

  • Investigational Site Number 203001

    Olomouc, 77520

  • Investigational Site Number 203004

    Prague, 12808

Other trials in Czechia

Denmark4 sites

  • Investigational Site Number 208004

    Aalborg, 9100

  • Investigational Site Number 208002

    Herlev, 2730

  • Investigational Site Number 208001

    København Ø, 2100

  • Investigational Site Number 208003

    Odense C, 5000

Other trials in Denmark

Peru4 sites

  • Investigational Site Number 604006

    Lima, 027

  • Investigational Site Number 604001

    Lima, 041

  • Investigational Site Number 604005

    Lima, LIMA 01

  • Investigational Site Number 604002

    Lima, LIMA 34

Other trials in Peru

Taiwan4 sites

  • Investigational Site Number 158004

    Kaohsiung City, 833

  • Investigational Site Number 158002

    Taichung, 407

  • Investigational Site Number 158001

    Taipei

  • Investigational Site Number 158003

    Taoyuan, 333

Other trials in Taiwan

Belarus3 sites

  • Investigational Site Number 112001

    Minsk, 220013

  • Investigational Site Number 112002

    Minsk, 223040

  • Investigational Site Number 112004

    Vitebsk, 210603

Other trials in Belarus

Finland3 sites

  • Investigational Site Number 246002

    Helsinki, 00290

  • Investigational Site Number 246001

    Kuopio, 70210

  • Investigational Site Number 246003

    Turku, FIN-20520

Other trials in Finland

Israel3 sites

  • Investigational Site Number 376004

    Kfar Saba, 44281

  • Investigational Site Number 376003

    Petah Tikva, 49100

  • Investigational Site Number 376002

    Tel Aviv, 64239

Other trials in Israel

Sweden3 sites

  • Investigational Site Number 752003

    Malmö, 205 02

  • Investigational Site Number 752002

    Stockholm, 171 76

  • Investigational Site Number 752001

    Uppsala, 751 85

Other trials in Sweden

Turkey (Türkiye)2 sites

  • Investigational Site Number 792002

    Ankara, 06100

  • Investigational Site Number 792001

    Istanbul, 34303

Other trials in Turkey (Türkiye)

About this study

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

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.
Read more

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.
Read the 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.

Conditions
Prostate Cancer
Being tested
Cabazitaxel (XRP6258), Docetaxel (XRP6976), Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cabazitaxel (XRP6258)Drug

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

  • Docetaxel (XRP6976)Drug

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

  • PrednisoneDrug

    Pharmaceutical form: Tablet; Route of administration: Oral

Study groups in NCT01308567
Study groupRoleWhat they receive
Cabazitaxel 25 mg/m^2ExperimentalCabazitaxel 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.
Receives: Drug: Cabazitaxel (XRP6258); Drug: Prednisone
Cabazitaxel 20 mg/m^2ExperimentalCabazitaxel 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.
Receives: Drug: Cabazitaxel (XRP6258); Drug: Prednisone
Docetaxel 75 mg/m^2Active comparatorDocetaxel (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.
Receives: Drug: Docetaxel (XRP6976); Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (10)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

    Measured: 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. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2011 (estimated)
  2. Study start5 May 2011
  3. Primary completionSep 2015
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01308567
Sponsor's protocol ID
EFC11784
Other IDs
2010-022064-12, U1111-1117-8356
Acronym
FIRSTANA
Status last verified
May 2019
First submitted
3 Mar 2011
Last updated
5 Jun 2019
Data monitoring committee
Yes

Publications

  • Carrot A, Oudard S, Colomban O, Fizazi K, Maillet D, Sartor O, Freyer G, You B. Prognostic Value of the Modeled Prostate-Specific Antigen KELIM Confirmation in Metastatic Castration-Resistant Prostate Cancer Treated With Taxanes in FIRSTANA. JCO Clin Cancer Inform. 2024 Feb;8:e2300208. doi: 10.1200/CCI.23.00208.

    PubMed 38364191

  • 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.

    PubMed 33740734

  • 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.

    PubMed 29500065

  • 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.

    PubMed 28753384

  • 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.

    PubMed 24722180

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

    PubMed 23228299

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cabazitaxel (XRP6258), Docetaxel (XRP6976) and Prednisone in people with Prostate Cancer, run by Sanofi at 167 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Australia, France, Ukraine, Mexico and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308567, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in