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Taxane
Docetaxel vs Cabazitaxel for Prostate Cancer (CABPOSTAAT Trial)
Phase 2
Waitlist Available
Led By fred Saad, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Appearance of 2 or more new bone lesions. They must be confirmed by other imaging modalities (CT; MRI) if ambiguous results (PCWG2), and/or
Progressive disease (PD) while receiving AR targeted therapy with abiraterone acetate or enzalutamide by at least one of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hrough study completion, an average of 1 year
Awards & highlights
CABPOSTAAT Trial Summary
This trial is a Phase II study of Cabazitaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). The study is designed to determine if cabazitaxel improves progression free survival (PFS) or overall survival (OS). Eligible patients must have been previously treated and progressed under docetaxel or abiraterone regimen.
Who is the study for?
Men with advanced prostate cancer that has spread and worsened despite hormone therapy with abiraterone or enzalutamide. They must have a rising PSA level, measurable disease progression, effective castration (low testosterone), and be able to consent. Excluded are those who've had certain prior treatments, uncontrolled other cancers or medical conditions, severe side effects from past cancer therapies, or inadequate organ function.Check my eligibility
What is being tested?
The trial is testing whether Cabazitaxel plus prednisone can improve survival for men with metastatic castration-resistant prostate cancer compared to Docetaxel plus prednisone after previous treatment failure. It's a Phase II study focusing on progression-free and overall survival outcomes.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the drugs used; blood disorders like low red cells, white cells or platelets; liver issues indicated by altered enzyme levels; heart problems in those with history of heart disease; gastrointestinal complications such as ulcers; and possible hormonal imbalances.
CABPOSTAAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least 2 new bone lesions confirmed by CT or MRI.
Select...
My cancer has worsened despite treatment with abiraterone or enzalutamide.
Select...
My cancer has grown or spread, and it can be measured by scans.
Select...
My prostate cancer was confirmed by a lab test.
Select...
My cancer has spread to other parts of my body.
Select...
My testosterone levels are very low, meeting the castration criteria.
CABPOSTAAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hrough study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hrough study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PSA response rate at 6 and 12 months
Secondary outcome measures
Duration of tumor response
Overall Survival
Pain response: BPI-SF pain intensity item scores
+4 moreCABPOSTAAT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cabazitaxel plus prednisoneExperimental Treatment1 Intervention
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
Group II: Docetaxel plus prednisoneActive Control1 Intervention
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
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Who is running the clinical trial?
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,415 Total Patients Enrolled
8 Trials studying Prostate Cancer
442 Patients Enrolled for Prostate Cancer
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,423 Total Patients Enrolled
5 Trials studying Prostate Cancer
2,109 Patients Enrolled for Prostate Cancer
fred Saad, MDPrincipal InvestigatorCHUM
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped taking hormone therapy for cancer at least 2 weeks ago.I have at least 2 new bone lesions confirmed by CT or MRI.My cancer has grown or spread, and it can be measured by scans.My cancer has worsened despite treatment with abiraterone or enzalutamide.I have no major side effects from cancer treatment, except for hair loss.It has been less than 28 days since my last surgery or radiation treatment.I have not had extensive radiation therapy affecting my bone marrow.This criterion is not applicable to my condition.I have had prostate cancer treatment, but not recent chemotherapy or after my last AR therapy.I am younger than 18 or below the legal age of majority in my country.I do not have a history of brain metastases or current brain/spinal cord issues.My daily activity is somewhat limited by my health.I had cancer before, but it was either skin cancer treated successfully, superficial bladder cancer, or any cancer treated over 5 years ago with no signs of disease since then.I have not been in another clinical trial or taken any experimental drugs in the last 30 days.In the last 3 months, I haven't had severe stomach issues, bowel diseases, lung clots, or uncontrolled blood clots.I have AIDS or HIV that needs treatment.I have a known history of abnormal aldosterone levels.My organs and bone marrow are not functioning properly.I cannot swallow pills whole.My liver disease is moderately to severely impaired.I cannot take corticosteroid medications due to health reasons.I do not have severe nerve pain or tingling in my hands and feet.I have had serious heart issues or a heart attack in the last year.My prostate cancer was confirmed by a lab test.My cancer has spread to other parts of my body.My testosterone levels are very low, meeting the castration criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Docetaxel plus prednisone
- Group 2: Cabazitaxel plus prednisone
Awards:
This trial has 3 awards, including:- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is patient enrollment in this research currently available?
"According to the records accessible on clinicaltrials.gov, this medical experiment is actively seeking participants. It was initially posted in April 2019 and most recently modified in August 2021."
Answered by AI
What adverse effects are associated with taking Cabazitaxel in combination with prednisone?
"Cabazitaxel plus prednisone demonstrates some evidence of safety, so it earned a score of 2 on our scale. This is because the drug has yet to be evaluated for efficacy in any formal trials."
Answered by AI
How many participants are actively involved in this research endeavor?
"Affirmative. Clinicaltrials.gov states that this medical experiment is actively enrolling participants. The trial was initially published on April 1st 2019 and last modified on August 9th 2021, presently aiming to recruit 214 individuals from a single site."
Answered by AI
What pathologies does Cabazitaxel plus prednisone provide relief for?
"Cabazitaxel in conjunction with prednisone has potential application for treating ulcerative colitis, varicella-zoster virus acute retinal necrosis, and brain conditions. Additionally, it can be used therapeutically to manage thyroiditis."
Answered by AI
Are there any other trials in the scientific literature that evaluate Cabazitaxel plus prednisone?
"At present, 647 experiments are in progress investigating the efficacy of cabazitaxel plus prednisone. Out of those trials, 212 have reached Phase 3 status. Primarily located in Duarte, California; however there is an additional 37 039 sites running these studies for this pharmaceutical combination."
Answered by AI
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