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Prostate Cancer MetastaticPhase 3CABASTYNCT02961257

Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel

A Phase 3 study testing cabazitaxel, Prednisone and Granulocyte colony-stimulating factor (G-CSF) in people with Prostate Cancer Metastatic, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 31 sites in 2 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

The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a… Read more about this study

Who is it for?
Ages 65 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
cabazitaxel, Prednisone and Granulocyte colony-stimulating factor (G-CSF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
31 sitesin 2 countries
Study dates
5 May 2017to 2 Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

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 65 years and older
  • Men only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient aged ≥ 65 years with mCRPC previously treated with docetaxel
  • Medical or surgical castration with castrate level of testosterone (< 50 ng/dl) based on the EAU definition of castrate level of testosterone
  • Progressive disease according to PCWG2
  • Histologically proven prostate carcinoma
  • Health status allowing use of chemotherapy: G8 > 14; or G8 score ≤ 14 with geriatric assessment concluding to reversible impairment allowing use of chemotherapy
  • ECOG-PS 0, 1 or 2(ECOG-PS 2 should be related to prostate cancer)
Show all 15Show fewer
  • Adequate hematologic, liver and renal functions:
  • Neutrophil count ≥1.5 109/L
  • Haemoglobin ≥10 g/ dL
  • Platelet count ≥100.109/L
  • Total bilirubin ≤ 1 the upper limit of normal (ULN)
  • Transaminases ≤ 1.5 ULN
  • Serum creatinine ≤ 2.0 ULN
  • Ongoing LHRH therapy at study entry
  • Signed informed consent

Who cannot join

  • History of severe hypersensitivity reaction (≥grade 3) to docetaxel
  • History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix E)
  • PS >2 not related to prostate cancer disease
  • G8 ≤ 14 with geriatric assessment contra-indicating standard cabazitaxel regimen
Show all 9Show fewer
  • Concomitant vaccination with yellow fever vaccine
  • Patient who cannot be regularly followed or cannot answer to quality of life questionnaires because of psychological, social, familial or geographic reasons
  • Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

France23 sites

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Hôpital Saint André, CHU de Bordeaux

    Bordeaux, 33075

  • Clinique Pasteur-CFRO

    Brest, 29229

  • Centre Maurice Tubiana

    Caen, 14000

  • Polyclinique Saint-Côme

    Compiègne, 60204

  • CHU Henri-Mondor

    Créteil, 94000

  • Clinique Victor Hugo

    Le Mans, 72000

  • Centre Oscar Lambret Lille

    Lille, 59000

  • Hôpital Belle-Isle

    Metz, 57045

  • GHIRM

    Montfermeil, 93370

  • Institut de Cancérologie du Gard - CHU

    Nîmes, 30029

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Hôpital Universitaire Tenon

    Paris, 75020

  • Hôpital Cochin

    Paris, 75679

  • CHU de Poitiers

    Poitiers, 86021

  • CHU de Rouen

    Rouen, 76000

  • Clinique Armoricaine de Radiologie

    Saint-Brieuc, 22015

  • HIA Bégin 69 avenue de Paris

    Saint-Mandé, 94160

  • Centre Hospitalier de Sens

    Sens, 89100

  • Hôpitaux universitaires de Strasbourg

    Strasbourg, 67000

  • Hôpital FOCH

    Suresnes, 92151

  • Centre de cancérologie Les Dentellières

    Valenciennes, 59300

Other trials in France

Germany8 sites

  • Urologisch-onkologische Schwerpunktpraxis

    Bernburg, 06406

  • Uniklinik Köln, Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie

    Cologne, 50937

  • Urologie und Kinderurologie Marienkrankenhaus Bergisch

    Gladbach, 51465

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Universitäts-klinik für Urologie und Kinderurologie

    Magdeburg, 39104

  • Urologische Praxis am Hasselbachplatz

    Magdeburg, 39104

  • Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie,

    Münster, 48149

  • Studienpraxis Urologie

    Nürtingen, 72622

Other trials in Germany

About this study

Official title: Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 65years) With mCRPC Previously Treated With a Docetaxel-containing Regimen

The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

Read the detailed description

Randomized, open-label, phase 3 trial in mCRPC patients aged ≥ 65 years.

Number of subjects:

Total:170 to 200 (85 to 100 per arm)

Treatment:

  • Arm A : cabazitaxel 25 mg/m² on Day 1 of a 3-week cycle plus daily prednisone or
  • Arm B: cabazitaxel 16 mg/m² on Day 1 and Day 15 of a 4-week cycle plus daily prednisone.
  • Treatment will be continued for a maximum of 10 cycles unless there is documented disease progression or unacceptable toxicity.
  • Standard cabazitaxel premedication will be used
  • Prophylactic G-CSF (GRANOCYTE) will be injected from Day 3 to Day 7 after every administration cycle of cabazitaxel· All new hormonal treatment, including ODM-201, prior to study entry is allowed.
  • Patients who received Radium-223 are eligible for this study
  • Treatment with LHRH should not be discontinued.

Exploratory assessments:

CT-Scan (abdominal/pelvic/chest) or whole body MRI and Bone scan: at screening, every 3 months and EOT.

FACT-P questionnaire:at C1D1,each subsequent visit and EOT

Exploratory substudy Blood samples will be collected in France (4 or 6 sites) and the Netherlands (2 sites). Biomarker analysis will be conducted at the Urology and The Tumor Immunology Laboratory at Radboud UMC in NL.

Biomarker schedule Arm A (25mg/m2): Baseline - Week 6 - Week 12 - at progression Arm B (16mg/m2): Baseline - Week 6 - Week 12 - at progression Optional sample points are at C1D8.

Number of subjects: 50

Statistical analysis:

A sample size of 77 to 90 evaluable patients per arm will achieve 80% power to detect a 20% difference in G3 neutropenia incidence between the 2 arms. The incidence in group cabazitaxel 25 mg/m2 q3w is assumed to be 32% and 12% on bi-weekly cabazitaxel arm. The test used is a two-sided Fisher's exact test at 0.05 significance level. Assuming 10% non-evaluable patients, 85 to 100 patients should be included in each arm for a total of 170 to 200.

Patients will be stratified according to G8 score (< 14 vs. ≥ 14), and age (< 70 vs. ≥ 70) before randomization.

Exploratory sub-study The trial is powered on a clinical endpoint, namely to detect a 20% difference in G3 nThe trial is powered on a clinical endpoint, namely to detect a 20% difference in G3 neutropenia incidence between arms (32% in arm A vs 12% arm B; power 80% with two-sided alpha of 5%, correcting for 10% non-evaluable patients (=17 patients).

From the 153 to 180 evaluable patients, we have 76 to 90 patients in each arm, of which we expect 40-60 evaluable patients for translational studies (calculations performed on 25 per arm).

In arm A, we expect 8 patients (32% of patients) with G3 neutropenia, and 17 patients that do not. In arm B, we expect 3 patients (12% of patients) with G3 neutropenia, and 22 patients that do not. For the MDSC analyses, we therefore will be comparing 11 patients with G3 neutropenia to 39 patients.

For all continuous variables, including all immune subpopulations present in blood, mean (sd) will be presented if the distribution seems to be symmetric and in case of a skewed distribution the median and IQR. For categorical data, number and percentage will be presented. For comparison of continuous data linear regression analyses or correlation (Spearman or Pearson) will used. For comparison of continuous data with categorical data logistic regression analysis will be used. For comparison of two sets of categorical data the chi-square test of Fisher's exact test will be utilized. For the radiological PFS analyses the estimates of the hazard ratio and corresponding 95% confidence interval will be tested using a Cox Proportional hazard model. For the overall survival, a stratified log-rank test will be used to compare between groups.

Being tested
cabazitaxel, Prednisone, Granulocyte colony-stimulating factor (G-CSF)

What participants receive

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

  • cabazitaxelDrug

    Also called Jevtana, XRP6258

    • Arm A : cabazitaxel 25 mg/m² on Day 1 of a 3-week cycle plus daily prednisone or
    • Arm B: cabazitaxel 16 mg/m² on Day 1 and Day 15 of a 4-week cycle plus daily prednisone.
    • Treatment will be continued for a maximum of 10 cycles unless there is documented disease progression or unacceptable toxicity.
    • Standard cabazitaxel premedication will be used

  • PrednisoneDrug

    Arm A:plus prednisone 10 mg orally given daily for a maximum of 10 cycles Arm B: plus prednisone 10 mg orally given per day up to 10 cycles

  • Granulocyte colony-stimulating factor (G-CSF)Drug

    Also called Granocyte

    Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) will be injected from Day 3 to Day 7 after every administration of cabazitaxel

Study groups in NCT02961257
Study groupRoleWhat they receive
Arm AExperimentalCabazitaxel 25 mg/m² intravenously over 1 hour on Day 1of a 3-week cycle, plus prednisone (or prednisolone) 10 mg orally given daily for a maximum of 10 cycles (ie 30 weeks of treatment). Prophylactic Granulocyte colony-stimulating factor G-CSF (Granocyte) will be injected from Day 3 to Day 7 after every administration of cabazitaxel.
Receives: Drug: cabazitaxel; Drug: Prednisone; Drug: Granulocyte colony-stimulating factor (G-CSF)
Arm BExperimentalCabazitaxel 16 mg/m2 on Day 1 and Day 15 of a 4-week cycle plus prednisone (or prednisolone) 10 mg per day up to 10 cycles (ie 40 weeks of treatment). Prophylactic Granulocyte colony-stimulating factor G-CSF (Granocyte) will be injected from Day 3 to Day 7 after every administration of cabazitaxel.
Receives: Drug: cabazitaxel; Drug: Prednisone; Drug: Granulocyte colony-stimulating factor (G-CSF)

What is being measured

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

  1. Number of grade ≥ 3 neutropenia and/or neutropenic complications

    To evaluate the incidence of grade ≥ 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

    with two schedules of -+cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men with mCRPC previously treated with a docetaxel-containing regimen

    Measured: Up to 11 months

Secondary outcomes (15)

  1. Dose reductions

    Up to 11 months

    Measured: through study completion, an average of 40 weeks

  2. Radiological progression-free survival (rPFS)

    CT-Scan (abdominal/pelvic/chest) or whole body MRI and Bone scan

    Measured: Up to 11 months

  3. Time to PSA progression

    Assessed at C1D1, at every each subsequent visit and EOT

    Measured: Up to 11 months

  4. Time to first symptomatic Skeletal-Related Event (SRE) and incidence of SREs

    Assessed at C1D1, at every each subsequent visit and EOT

    Measured: Up to 11 months

  5. Time to opioid treatment (if relevant)

    Measured: Up to 11 months

  6. Prostate-specific antigen (PSA) response rate

    Assessed at C1D1, at every each subsequent visit and EOT

    Measured: Up to 11 months

  7. Quality of Life (FACT-P)

    Assessed at C1D1, at every each subsequent visit and EOT

    Measured: Up to 11 months

  8. Objective response rate (ORR) in measurable lesions (RECIST criteria 1.1 - only on metastasis

    CT-Scan (abdominal/pelvic/chest) or whole body MRI

    Measured: Up to 11 months

  9. Overall Survival (OS)

    Measured: up to 11 months

  10. Factors influencing survival

    Factors influencing survival (duration of response to first ADT, serum testosterone, cumulative dose of cabazitaxel, neutrophils/lymphocytes ratio, Gleason score, G8, grade ≥3 neutropenia)

    Measured: Up to 11 months

  11. Time to onset of grade ≥3 neutropenia

    Hematology every week until EOT

    Measured: Up to 11 months

  12. Grade ≥3 neutropenia duration ( from date of onset of grade ≥ 3 until grade ≤ 2)

    Hematology every week until EOT

    Measured: Up to 11 months

  13. Time to onset of grade ≥3 neutropenia by cycle

    Analysis of grade ≥3 neutropenia and/or neutropenia by cycle

    Measured: Up to 11 months

  14. Adverse events

    Measured: Up to 11 months

  15. Dose delay

    Measured: Up to 11 months

Timeline

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

  1. First posted10 Nov 2016 (estimated)
  2. Study start5 May 2017
  3. Primary completion2 Dec 2021
  4. Study completion2 Dec 2021

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
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02961257
Sponsor's protocol ID
CABASTY
Acronym
CABASTY
Status last verified
May 2019
First submitted
22 Aug 2016
Last updated
12 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Oudard S, Ratta R, Voog E, Barthelemy P, Thiery-Vuillemin A, Bennamoun M, Hasbini A, Aldabbagh K, Saldana C, Sevin E, Amela E, Von Amsberg G, Houede N, Besson D, Feyerabend S, Boegemann M, Pfister D, Schostak M, Huillard O, Di Fiore F, Quivy A, Lange C, Phan L, Belhouari H, Tran Y, Kotti S, Helissey C. Biweekly vs Triweekly Cabazitaxel in Older Patients With Metastatic Castration-Resistant Prostate Cancer: The CABASTY Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Dec 1;9(12):1629-1638. doi: 10.1001/jamaoncol.2023.4255.

    PubMed 37883073

  • Pobel C, Auclin E, Procureur A, Clement-Zhao A, Simonaggio A, Delanoy N, Vano YA, Thibault C, Oudard S. Cabazitaxel schedules in metastatic castration-resistant prostate cancer: a review. Future Oncol. 2021 Jan;17(1):91-102. doi: 10.2217/fon-2020-0672. Epub 2020 Dec 2.

    PubMed 33463373

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cabazitaxel, Prednisone and Granulocyte colony-stimulating factor (G-CSF) in people with Prostate Cancer Metastatic, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 31 sites in 2 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 15 inclusion and 9 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 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France, Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of grade ≥ 3 neutropenia and/or neutropenic complications (time frame: Up to 11 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 NCT02961257, which also lists 3 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 12 May 2022.

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