Metastatic Prostate CancerPhase 2CABPOSTAATNCT03764540
Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide
A Phase 2 study testing Cabazitaxel plus prednisone and Docetaxel plus prednisone in people with Metastatic Prostate Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Prostate cancer (PCa) is the most frequently diagnosed cancer in Canadian men. While the majority of PCa is slow growing and responds well to first line treatment, a proportion of cases (10%) progress to metastatic form resulting in more than 4 000 deaths annually in Canada and 250 000 worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Cabazitaxel plus prednisone and Docetaxel plus prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 31 Dec 2024
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of histologically or cytologically confirmed prostate adenocarcinoma.
- Metastatic disease.
- Progressive disease (PD) while receiving AR targeted therapy with abiraterone acetate or enzalutamide by at least one of the following:
- Progression in measurable disease (RECIST 1.1 criteria). Patient with measurable disease must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm when measured by computed tomography (CT) [CT scan thickness no greater than 5 mm] or magnetic resonance imaging (MRI). Lymph nodes should be ≥ 15 mm in short axis. As defined by PCWG2, if lymph node metastasis is the only evidence of metastasis, it must be ≥ 20 mm in diameter when measured by spiral CT or MRI. Previously irradiated lesions, primary prostate lesion and bone lesions will be considered non-measurable disease, and/or
- Appearance of 2 or more new bone lesions. They must be confirmed by other imaging modalities (CT; MRI) if ambiguous results (PCWG2), and/or
- Rising PSA defined (PCWG2) as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart. The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA measure is required to be taken and be greater than the 2nd measure. The third (or the fourth) confirmatory PSA should be taken within 4 weeks prior to randomization.
Show all 10Show fewer
- A PSA value of at least 2 ng/mL is required at study entry.
- Effective castration (serum testosterone levels ≤0.5 ng/mL).
- Prior AR targeted therapy (abiraterone acetate or enzalutamide) must be stopped at least 2 weeks before study treatment.
- Signed written informed consent.
Who cannot join
- Related to methodology:
- Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago. Prior treatment with sipuleucel T immunotherapy is allowed at the condition patient did not received prior chemotherapy. No further anti-cancer therapy after the previous AR targeted therapy and before inclusion.
- Less than 28 days elapsed from prior treatment with radiotherapy or surgery to the time of randomization.
- Prior isotope therapy, whole bony pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
- 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] v4.0) at the time of randomization.
- Less than 18 years (or country's legal age of majority if the legal age is >18 years).
Show all 31Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status >1.
- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
- Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which treatment has been completed ≥5 years ago and from which the patient has been disease-free for ≥5 years.
- Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
- 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.
- Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
- Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
- Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose. The definition of "effective method of contraception" will be based on the investigator's judgment.
- Related to study treatment
- Known allergies, hypersensitivity or intolerance to prednisone. History of hypersensitivity to docetaxel or polysorbate 80.
- Known history of mineralocorticoid excess or deficiency.
- Unable to swallow a whole tablet or capsule
- Inadequate organ and bone marrow function as evidenced by:
- Hemoglobin <10.0 g/dL
- Absolute neutrophil count <1.5 x 109/L
- Platelet count <100 x 109/L
- AST/SGOT and/or ALT/SGPT >1.5 x ULN;
- Total bilirubin >1.0 x ULN
- Potassium <3.5 mmol/L
- Serum albumin <3.0 g/dL
- Child-Pugh Class B and C
- Serum Creatinine ≤ 1.5 x ULN,
- Contraindications to the use of corticosteroid treatment.
- Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v.4.0).
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac left ventricular ejection fraction (LVEF) measurement of <50% at baseline.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
About this study
Official title: Randomized Phase II Study of Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide Progression
Prostate cancer (PCa) is the most frequently diagnosed cancer in Canadian men. While the majority of PCa is slow growing and responds well to first line treatment, a proportion of cases (10%) progress to metastatic form resulting in more than 4 000 deaths annually in Canada and 250 000 worldwide. Currently, first line treatment for PCa includes surgery, radiation and androgen deprivation therapy (ADT). A rapid evolution in the understanding of disease biology, combined with approvals of new therapies including immunotherapy, novel chemotherapy, hormonal agents and a bone calcium matrix-targeted radionuclide, along with further drugs in development, have made treatment decisions for metastatic castration-resistant prostate cancer (mCRPC) increasingly complex and challenging.
This is a Phase II Study of Cabazitaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). The current study is designed to determine if cabazitaxel will improve progression free survival (PFS) or overall survival (OS).
Read more
This study will enroll patients with mCRPC, who have been previously treated and progressed under docetaxel or abiraterone regimen.
Patients must meet the study eligibility criteria and must be competent to give informed consent.
Read the detailed description
This is a prospective, multicenter, national, randomized, open label study, comparing the efficacy of cabazitaxel at 25 mg/m² plus prednisone (Arm A) over docetaxel at 75mg/m2 plus prednisone (Arm B) after enzalutamide at 160 mg once daily or abiraterone acetate at 1000 mg once daily plus prednisone in chemotherapy-naïve patients with mCRPC who have progressed on abiraterone acetate or enzalutamide.
Each patient will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment.
All eligible patients will be randomly assigned to either arm A or B in a 1:1 proportion.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Cabazitaxel plus prednisone, Docetaxel plus 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 plus prednisoneDrug
Also called Experimental
Cabazitaxel 25 mg/m² intravenously on day 1 of each cycle, plus prednisone 10 mg orally given daily.
A cycle is defined as a 3-weeks period for a maximum of 10 cycles.
Docetaxel plus prednisoneDrug
Also called Active Comparator
Docetaxel 75 mg/m² intravenously on day 1 of each cycle, plus prednisone 10 mg orally given daily.
A cycle is defined as a 3-weeks period for a maximum of 10 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel plus prednisone | Experimental | Cabazitaxel: Single-dose vial, containing a total of 60 mg of cabazitaxel expressed as anhydrous and solvent-free basis, per 1.5 mL of solution. Cabazitaxel will be administered by IV route Prednisone will be administered orally, 5 mg twice daily (10 mg per day total dose).
Prednisone will be administered by oral route Receives: Drug: Cabazitaxel plus prednisone |
| Docetaxel plus prednisone | Active comparator | Docetaxel is formulated in polysorbate 80 and commercially available as 80 mg/2.0 mL single-dose vials with accompanying diluent (13% ethanol in water for injection) for IV use.
Prednisone will be administered orally, 5 mg twice daily (10 mg per day total dose).
Prednisone will be administered by oral route Receives: Drug: Docetaxel plus prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response rate at 6 and 12 months
Change from baseline PSA level of at least 50%, PSA partial response is defined as a ≥ 50% decline in PSA from cycle 1 day 1 (baseline) PSA value. This PSA change must be confirmed as sustained by a second PSA value obtained ≥ 3 weeks later.
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Radiological progression-free survival (rPFS)
Time interval between the date of randomization and the date of the first documentation of any of the following event. Radiological tumor progression by RECIST 1.1 and PCWG2,
Measured: through study completion, an average of 1 year
Overall Survival
Time interval from the date of randomization to the date of death due to any cause
Measured: through study completion, an average of 1 year
Time to PSA progression (TTPP)
Time interval between the date of randomization and the date of first documented PSA progression.
Measured: through study completion, an average of 1 year
Tumor response
Measurable by RECIST 1.1
Measured: through study completion, an average of 1 year
Duration of tumor response
Time between the first evaluation at which the tumor response criteria are met and the first documentation of tumor progression.
Measured: hrough study completion, an average of 1 year
Pain response: BPI-SF pain intensity item scores
Decrease by <30% from baseline in the average of BPI-SF pain intensity item scores (items 3, 4, 5, and 6) observed at 2 consecutive evaluations ≥3 weeks apart without increase in analgesic usage score.
Measured: through study completion, an average of 1 year
Time to Pain progression
Time interval between the date of randomization and the date of the first documented pain progression
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Apr 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: The cabazitaxel was recently approved by the regulatory authorities for mCRPCa
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- fred Saad, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764540
- Sponsor's protocol ID
- MP-02-2018-7545
- Acronym
- CABPOSTAAT
- Status last verified
- Jan 2025
- First submitted
- 3 Dec 2018
- Last updated
- 13 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide Progression
- ClinicalTrials.gov ID
- NCT03764540
- Acronym / sponsor ID
- CABPOSTAAT / MP-02-2018-7545
- Conditions
- Metastatic Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The cabazitaxel was recently approved by the regulatory authorities for mCRPCa
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer (PCa) is the most frequently diagnosed cancer in Canadian men. While the majority of PCa is slow growing and responds well to first line treatment, a proportion of cases (10%) progress to metastatic form resulting in more than 4 000 deaths annually in Canada and 250 000 worldwide. Currently, first line treatment for PCa includes surgery, radiation and androgen deprivation therapy (ADT). A rapid evolution in the understanding of disease biology, combined with approvals of new therapies including immunotherapy, novel chemotherapy, hormonal agents and a bone calcium matrix-targeted radionuclide, along with further drugs in development, have made treatment decisions for metastatic castration-resistant prostate cancer (mCRPC) increasingly complex and challenging.
This is a Phase II Study of Cabazitaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). The current study is designed to determine if cabazitaxel will improve progression free survival (PFS) or overall survival (OS).
This study will enroll patients with mCRPC, who have been previously treated and progressed under docetaxel or abiraterone regimen.
Patients must meet the study eligibility criteria and must be competent to give informed consent.
Detailed description
This is a prospective, multicenter, national, randomized, open label study, comparing the efficacy of cabazitaxel at 25 mg/m² plus prednisone (Arm A) over docetaxel at 75mg/m2 plus prednisone (Arm B) after enzalutamide at 160 mg once daily or abiraterone acetate at 1000 mg once daily plus prednisone in chemotherapy-naïve patients with mCRPC who have progressed on abiraterone acetate or enzalutamide.
Each patient will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment.
All eligible patients will be randomly assigned to either arm A or B in a 1:1 proportion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel plus prednisone | Experimental | Drug: Cabazitaxel plus prednisoneCabazitaxel: Single-dose vial, containing a total of 60 mg of cabazitaxel expressed as anhydrous and solvent-free basis, per 1.5 mL of solution. Cabazitaxel will be administered by IV route Prednisone will be administered orally, 5 mg twice daily (10 mg per day total dose). Prednisone will be administered by oral route |
| Docetaxel plus prednisone | Active comparator | Drug: Docetaxel plus prednisoneDocetaxel is formulated in polysorbate 80 and commercially available as 80 mg/2.0 mL single-dose vials with accompanying diluent (13% ethanol in water for injection) for IV use. Prednisone will be administered orally, 5 mg twice daily (10 mg per day total dose). Prednisone will be administered by oral route |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of histologically or cytologically confirmed prostate adenocarcinoma.
- Metastatic disease.
- Progressive disease (PD) while receiving AR targeted therapy with abiraterone acetate or enzalutamide by at least one of the following:
- Progression in measurable disease (RECIST 1.1 criteria). Patient with measurable disease must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm when measured by computed tomography (CT) [CT scan thickness no greater than 5 mm] or magnetic resonance imaging (MRI). Lymph nodes should be ≥ 15 mm in short axis. As defined by PCWG2, if lymph node metastasis is the only evidence of metastasis, it must be ≥ 20 mm in diameter when measured by spiral CT or MRI. Previously irradiated lesions, primary prostate lesion and bone lesions will be considered non-measurable disease, and/or
- Appearance of 2 or more new bone lesions. They must be confirmed by other imaging modalities (CT; MRI) if ambiguous results (PCWG2), and/or
Key exclusion criteria (31 listed)
- Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago. Prior treatment with sipuleucel T immunotherapy is allowed at the condition patient did not received prior chemotherapy. No further anti-cancer therapy after the previous AR targeted therapy and before inclusion.
- Less than 28 days elapsed from prior treatment with radiotherapy or surgery to the time of randomization.
- Prior isotope therapy, whole bony pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
- 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] v4.0) at the time of randomization.
- Less than 18 years (or country's legal age of majority if the legal age is >18 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabazitaxel plus prednisoneAlso: ExperimentalCabazitaxel 25 mg/m² intravenously on day 1 of each cycle, plus prednisone 10 mg orally given daily. A cycle is defined as a 3-weeks period for a maximum of 10 cycles. | Drug | Cabazitaxel plus prednisone |
| Docetaxel plus prednisoneAlso: Active ComparatorDocetaxel 75 mg/m² intravenously on day 1 of each cycle, plus prednisone 10 mg orally given daily. A cycle is defined as a 3-weeks period for a maximum of 10 cycles. | Drug | Docetaxel plus prednisone |
Primary outcome
PSA response rate at 6 and 12 months
Time frame: through study completion, an average of 1 year
Change from baseline PSA level of at least 50%, PSA partial response is defined as a ≥ 50% decline in PSA from cycle 1 day 1 (baseline) PSA value. This PSA change must be confirmed as sustained by a second PSA value obtained ≥ 3 weeks later.
7 secondary outcomes
Radiological progression-free survival (rPFS)
Time frame: through study completion, an average of 1 year
Overall Survival
Time frame: through study completion, an average of 1 year
Time to PSA progression (TTPP)
Time frame: through study completion, an average of 1 year
Tumor response
Time frame: through study completion, an average of 1 year
Duration of tumor response
Time frame: hrough study completion, an average of 1 year
Pain response: BPI-SF pain intensity item scores
Time frame: through study completion, an average of 1 year
Time to Pain progression
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: The cabazitaxel was recently approved by the regulatory authorities for mCRPCa). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
Related trials for Metastatic Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fred Saad, MD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel plus prednisone and Docetaxel plus prednisone in people with Metastatic Prostate Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 10 inclusion and 31 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: stopped early, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The cabazitaxel was recently approved by the regulatory authorities for mCRPCa). Results are not available in the source record.
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?
PSA response rate at 6 and 12 months (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2025.