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Prostate CancerPhase 3PROSELICANCT01308580

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

A Phase 3 study testing Cabazitaxel (XRP6258) and Prednisone (or Prednisolone) in people with Prostate Cancer, run by Sanofi at 172 sites in 22 countries.

Completed

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

Official record
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Trial summary

Primary Objective: To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen. 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) and Prednisone (or Prednisolone)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
172 sitesin 22 countries
Study dates
Apr 2011to Aug 2015
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. 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

172 sites in 22 countries.

172 sites in 22 countries

United States21 sites

  • Investigational Site Number 840020

    Akron, Ohio, 44302

  • Investigational Site Number 840008

    Anaheim, California, 92801

  • Investigational Site Number 840014

    Baltimore, Maryland, 21231

  • Investigational Site Number 840025

    Chattanooga, Tennessee, 37421

  • Investigational Site Number 840012

    Corpus Christi, Texas, 78405

  • Investigational Site Number 840015

    East Orange, New Jersey, 07018

  • Investigational Site Number 840004

    Hot Springs, Arkansas, 71913

  • Investigational Site Number 840011

    Jackson, Mississippi, 39202

  • Investigational Site Number 840023

    Jacksonville, Florida, 32256

  • Investigational Site Number 840010

    La Jolla, California, 92093

  • Investigational Site Number 840013

    Lakeland, Florida, 33805

  • Investigational Site Number 840016

    Lincoln, Nebraska, 68506

  • Investigational Site Number 840002

    Muscle Shoals, Alabama, 35661

  • Investigational Site Number 840007

    New Orleans, Louisiana, 70112

  • Investigational Site Number 840006

    Pawtucket, Rhode Island, 02860

  • Investigational Site Number 840003

    Port Saint Lucie, Florida, 34952

  • Investigational Site Number 840024

    Raleigh, North Carolina, 27607

  • Investigational Site Number 840005

    Rockville, Maryland, 20850

  • Investigational Site Number 840017

    Saint Louis Park, Minnesota, 55416

  • Investigational Site Number 840001

    San Bernardino, California, 92404

  • Investigational Site Number 840021

    Stamford, Connecticut, 06902

Other trials in United States

Australia15 sites

  • Investigational Site Number 036014

    Adelaide, 5000

  • Investigational Site Number 036013

    Bankstown, 2200

  • Investigational Site Number 036010

    Box Hill, 3128

  • Investigational Site Number 036012

    Camperdown, 2050

  • Investigational Site Number 036008

    Coffs Harbour, 2450

  • Investigational Site Number 036001

    Concord, 2137

  • Investigational Site Number 036015

    Elizabeth Vale, 5112

  • Investigational Site Number 036009

    Fitzroy, 3065

  • Investigational Site Number 036007

    Garran, 2605

  • Investigational Site Number 036005

    Heidelberg West, 3081

  • Investigational Site Number 036002

    Malvern, 3144

  • Investigational Site Number 036006

    South Brisbane, 4101

  • Investigational Site Number 036016

    Subiaco, 6008

  • Investigational Site Number 036003

    Wahroonga, 2076

  • Investigational Site Number 036004

    Wodonga, 3690

Other trials in Australia

Belgium14 sites

  • Investigational Site Number 056007

    Antwerp, B-2020

  • Investigational Site Number 056001

    Brussels, 1000

  • Investigational Site Number 056008

    Brussels, 1090

  • Investigational Site Number 056002

    Brussels, 1200

  • Investigational Site Number 056009

    Charleroi, B-6000

  • Investigational Site Number 056003

    Ghent, 9000

  • Investigational Site Number 056012

    Godinne, B-5530

  • Investigational Site Number 056016

    Haine-Saint-Paul, 7100

  • Investigational Site Number 056005

    Hasselt, B-3500

  • Investigational Site Number 056010

    Libramont, 6800

  • Investigational Site Number 056013

    Liège, 4000

  • Investigational Site Number 056011

    Ottignies, 1340

  • Investigational Site Number 056004

    Roeselare, 8800

  • Investigational Site Number 056006

    Turnhout, B-2300

Other trials in Belgium

Brazil12 sites

  • Investigational Site Number 076016

    Fortaleza

  • Investigational Site Number 076012

    Ijuí, 98700 000

  • Investigational Site Number 076015

    Mogi das Cruzes, 08730-500

  • Investigational Site Number 076014

    Porto Alegre, 90110-270

  • Investigational Site Number 076010

    Rio de Janeiro, 22793-080

  • Investigational Site Number 076007

    Salvador, 41256-900

  • Investigational Site Number 076003

    São José do Rio Preto, 15090-000

  • Investigational Site Number 076009

    São Paulo, 01221-020

  • Investigational Site Number 076001

    São Paulo, 01308050

  • Investigational Site Number 076013

    São Paulo, 01321-001

  • Investigational Site Number 076008

    São Paulo, 01509-900

  • Investigational Site Number 076002

    São Paulo, 03102-002

Other trials in Brazil

France11 sites

  • Investigational Site Number 250005

    Avignon, 84918

  • Investigational Site Number 250008

    Hyères, 83400

  • Investigational Site Number 250001

    La Roche-sur-Yon, 85925

  • Investigational Site Number 250002

    Nantes, 44202

  • Investigational Site Number 250004

    Nîmes, 30029

  • Investigational Site Number 250010

    Paris, 75014

  • Investigational Site Number 250009

    Reims, 51056

  • Investigational Site Number 250007

    Reims, 51100

  • Investigational Site Number 250006

    Saint-Brieuc, 22015

  • Investigational Site Number 250003

    Toulouse, 31052

  • Investigational Site Number 250011

    Toulouse, 31076

Other trials in France

Germany11 sites

  • Investigational Site Number 276003

    Aachen, 52074

  • Investigational Site Number 276007

    Dresden, 01307

  • Investigational Site Number 276004

    Düsseldorf, 40225

  • Investigational Site Number 276001

    Erlangen, 91054

  • Investigational Site Number 276011

    Hamburg, 20246

  • Investigational Site Number 276005

    Hamburg, 22399

  • Investigational Site Number 276010

    Homburg, 66421

  • Investigational Site Number 276006

    München, 81675

  • Investigational Site Number 276012

    Nürtingen, 72622

  • Investigational Site Number 276008

    Tübingen, 72076

  • Investigational Site Number 276002

    Wuppertal, 42103

Other trials in Germany

Romania11 sites

  • Investigational Site Number 642005

    Alba Iulia, 510077

  • Investigational Site Number 642006

    Baia Mare, 430031

  • Investigational Site Number 642009

    Bucharest, 010976

  • Investigational Site Number 642008

    Bucharest, 022328

  • Investigational Site Number 642001

    Cluj-Napoca, 400015

  • Investigational Site Number 642003

    Cluj-Napoca, 400015

  • Investigational Site Number 642004

    Cluj-Napoca, 400015

  • Investigational Site Number 642002

    Cluj-Napoca, 400058

  • Investigational Site Number 642012

    Focşani, 620034

  • Investigational Site Number 642007

    Hunedoara, 331057

  • Investigational Site Number 642013

    Onești, 601048

Other trials in Romania

Russia9 sites

  • Investigational Site Number 643007

    Moscow, 105425

  • Investigational Site Number 643005

    Moscow, 115478

  • Investigational Site Number 643004

    Moscow, 117997

  • Investigational Site Number 643006

    Moscow, 125284

  • Investigational Site Number 643008

    Obninsk, 249036

  • Investigational Site Number 643001

    Saint Petersburg, 197022

  • Investigational Site Number 643010

    Saint Petersburg, 197758

  • Investigational Site Number 643003

    Tula, 300053

  • Investigational Site Number 643009

    Yekaterinburg, 620036

Other trials in Russia

Spain8 sites

  • Investigational Site Number 724003

    Badalona, 08916

  • Investigational Site Number 724001

    Barcelona, 08035

  • Investigational Site Number 724002

    Madrid, 28033

  • Investigational Site Number 724008

    Madrid, 28050

  • Investigational Site Number 724006

    Málaga, 29010

  • Investigational Site Number 724005

    Palma de Mallorca, 07010

  • Investigational Site Number 724004

    Sabadell, 08208

  • Investigational Site Number 724007

    Seville, 41071

Other trials in Spain

Peru7 sites

  • Investigational Site Number 604003

    Arequipa, 5154

  • Investigational Site Number 604006

    Lima, 027

  • Investigational Site Number 604001

    Lima, 041

  • Investigational Site Number 604007

    Lima, LIM27

  • Investigational Site Number 604002

    Lima, Lima -41

  • Investigational Site Number 604004

    Lima, LIMA 01

  • Investigational Site Number 604005

    Lima, Lima 41

Other trials in Peru

United Kingdom7 sites

  • Investigational Site Number 826002

    Birmingham, B18 7QH

  • Investigational Site Number 826004

    Colchester, CO3 3NB

  • Investigational Site Number 826005

    Glasgow, G11 6NT

  • Investigational Site Number 826006

    Guildford, GU2 7XX

  • Investigational Site Number 826007

    Manchester, M20 4BX

  • Investigational Site Number 826003

    Newcastle upon Tyne, NE7 7DN

  • Investigational Site Number 826001

    Sutton, SM2 5PT

Other trials in United Kingdom

Hungary5 sites

  • Investigational Site Number 348001

    Budapest, 1122

  • Investigational Site Number 348005

    Budapest, 1134

  • Investigational Site Number 348004

    Budapest, 1145

  • Investigational Site Number 348006

    Miskolc, 3526

  • Investigational Site Number 348003

    Pécs, 7624

Other trials in Hungary

Netherlands5 sites

  • Investigational Site Number 528005

    Arnhem, 6815 AD

  • Investigational Site Number 528003

    Blaricum, 1261 AN

  • Investigational Site Number 528004

    Hoofddorp, 2134 TM

  • Investigational Site Number 528002

    Nijmegen, 6525 GA

  • Investigational Site Number 528001

    Zwolle, 8025 AB

Other trials in Netherlands

Poland5 sites

  • Investigational Site Number 616006

    Lubin, 59-300

  • Investigational Site Number 616002

    Olsztyn, 10-228

  • Investigational Site Number 616001

    Rybnik, 44-200

  • Investigational Site Number 616005

    Siedlce, 08-110

  • Investigational Site Number 616004

    Torun, 87-100

Other trials in Poland

South Africa5 sites

  • Investigational Site Number 710003

    Cape Town, 7570

  • Investigational Site Number 710002

    Durban, 4001

  • Investigational Site Number 710005

    Johannesburg, 2193

  • Investigational Site Number 710004

    Johannesburg, 2196

  • Investigational Site Number 710001

    Pretoria, 0001

Other trials in South Africa

South Korea5 sites

  • Investigational Site Number 410003

    Seongnam, 463-707

  • Investigational Site Number 410002

    Seoul, 110-744

  • Investigational Site Number 410004

    Seoul, 120-752

  • Investigational Site Number 410005

    Seoul, 135-710

  • Investigational Site Number 410001

    Seoul, 138-736

Other trials in South Korea

Argentina4 sites

  • Investigational Site Number 032002

    Buenos Aires, C1120AAT

  • Investigational Site Number 032001

    Rosario, 2000

  • Investigational Site Number 032003

    Salta, A4406CLA

  • Investigational Site Number 032004

    Santa Fe, 3000

Other trials in Argentina

Canada4 sites

  • Investigational Site Number 124002

    Greenfield Park, J4V 2H1

  • Investigational Site Number 124001

    Oshawa, L1G 2B9

  • Investigational Site Number 124003

    Ottawa, K1H 8L6

  • Investigational Site Number 124005

    Owen Sound, N4K 2J1

Other trials in Canada

Chile4 sites

  • Investigational Site Number 152005

    Santiago, 751-0009

  • Investigational Site Number 152004

    Santiago, 7510032

  • Investigational Site Number 152002

    Santiago, 8380456

  • Investigational Site Number 152001

    Viña del Mar, 2540364

Other trials in Chile

Taiwan3 sites

  • Investigational Site Number 158002

    Taiching, 40447

  • Investigational Site Number 158003

    Tainan, 704

  • Investigational Site Number 158001

    Taipei, 100

Other trials in Taiwan

Tunisia3 sites

  • Investigational Site Number 788004

    Sfax, 3029

  • Investigational Site Number 788003

    Sousse, 4000

  • Investigational Site Number 788002

    Tunis, 1006

Other trials in Tunisia

Turkey (Türkiye)3 sites

  • Investigational Site Number 792003

    Antalya, 07059

  • Investigational Site Number 792001

    Bornova, 35100

  • Investigational Site Number 792002

    Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

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

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.
Read more

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.
Read the 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.

Conditions
Prostate Cancer
Being tested
Cabazitaxel (XRP6258), Prednisone (or Prednisolone)
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

    Also called Jevtana®

    Pharmaceutical form: Concentrate and solvent for solution for infusion

    Route of administration: Intravenous

  • Prednisone (or Prednisolone)Drug

    Pharmaceutical form: Tablet

    Route of administration: Oral

Study groups in NCT01308580
Study groupRoleWhat they receive
Cabazitaxel 20 mg/m^2ExperimentalCabazitaxel 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.
Receives: Drug: Cabazitaxel (XRP6258); Drug: Prednisone (or Prednisolone)
Cabazitaxel 25 mg/m^2ExperimentalCabazitaxel 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.
Receives: Drug: Cabazitaxel (XRP6258); Drug: Prednisone (or Prednisolone)

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 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.

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

Secondary outcomes (17)

  1. 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.

    Measured: 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)

  2. 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.

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

  3. 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.

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

  4. 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.

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

  6. 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.

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

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

  8. 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.

    Measured: 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)

  9. 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.

    Measured: 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)

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

  14. 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.

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

  15. 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.

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

  16. 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.

    Measured: 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

  17. 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.

    Measured: 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

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 startApr 2011
  3. Primary completionAug 2015
  4. Study completionAug 2015

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
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01308580
Sponsor's protocol ID
EFC11785
Other IDs
2010-022163-35
Acronym
PROSELICA
Status last verified
Aug 2016
First submitted
3 Mar 2011
Last updated
17 Apr 2017
Data monitoring committee
Yes

Publications

  • Vauchier C, Thibault C, Velev M, Becker O, Guillaume Z, Ashton E, Zaibet S, Berthou H, Courtinat F, Gervais C, Rochand A, Robbrecht D, Oudard S, Auclin E. Integrated Prognostic Score in Metastatic Castration-resistant Prostate Cancer Treated with Cabazitaxel - A CABASTY Post Hoc Analysis Validated by Two International Prospective Phase 3 Trials. Eur Urol Oncol. 2026 Apr 21:S2588-9311(26)00081-7. doi: 10.1016/j.euo.2026.03.022. Online ahead of print.

    PubMed 42020286

  • 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.

    PubMed 35677318

  • 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

  • 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.

    PubMed 28809610

  • 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) and Prednisone (or Prednisolone) in people with Prostate Cancer, run by Sanofi at 172 sites in 22 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 11 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, Australia, Belgium, Brazil, France and 17 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 11 Oct 2016). 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: From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 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 NCT01308580, 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 17 Apr 2017.

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