Docetaxel vs Cabazitaxel for Prostate Cancer
(CABPOSTAAT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare two treatments, docetaxel and cabazitaxel, for men with metastatic castration-resistant prostate cancer (mCRPC). Researchers seek to determine if cabazitaxel, a chemotherapy drug, can extend the time patients live without cancer progression. Participants should have prostate cancer that has spread and worsened despite previous treatments such as docetaxel or abiraterone. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
You must stop taking abiraterone acetate or enzalutamide at least 2 weeks before starting the study treatment. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that docetaxel is usually well-tolerated, but some risks exist. One study found that 34% of patients taking docetaxel were hospitalized, mostly due to febrile neutropenia, a condition where fever occurs with low levels of a specific white blood cell. Despite these risks, docetaxel has improved survival rates in patients with prostate cancer.
Cabazitaxel serves as another treatment option, often used after docetaxel. Although specific safety details aren't available from the sources, its approval for similar uses suggests general safety. However, as this is a phase 2 study, the trial aims to learn more about patients' tolerance to cabazitaxel.
Both treatments show promise but carry some risks. Patients should discuss with their healthcare team to determine the best option for them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for prostate cancer because both cabazitaxel and docetaxel offer unique benefits. While docetaxel is a well-established chemotherapy drug traditionally used for prostate cancer, cabazitaxel is gaining attention for its ability to overcome resistance seen in some patients who no longer respond to docetaxel. Cabazitaxel operates by disrupting cancer cell division in a slightly different way, potentially offering a fresh option for patients who have exhausted other treatments. Both drugs are paired with prednisone, which helps manage symptoms and enhance the effectiveness of the chemotherapy. This dual approach aims to improve outcomes for patients facing advanced stages of prostate cancer.
What evidence suggests that this trial's treatments could be effective for metastatic castration-resistant prostate cancer?
This trial will compare the effectiveness of cabazitaxel and docetaxel for treating advanced prostate cancer. Studies have shown that cabazitaxel, a type of chemotherapy, effectively treats advanced prostate cancer that no longer responds to hormone therapy. It has been proven to extend patients' lives and slow disease progression. Research indicates that cabazitaxel offers better survival outcomes than some treatments targeting hormone pathways. Meanwhile, docetaxel, another chemotherapy drug tested in this trial, has helped men with advanced prostate cancer live longer and specifically reduced deaths from prostate cancer. Both treatments have demonstrated benefits in managing advanced prostate cancer.678910
Who Is on the Research Team?
fred Saad, MD
Principal Investigator
CHUM
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either cabazitaxel plus prednisone or docetaxel plus prednisone until disease progression, unacceptable toxicity, or refusal of further treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Cabazitaxel
- Docetaxel
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
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
Cabazitaxel is already approved in European Union, United States, Canada, Japan for the following indications:
- Hormone refractory metastatic prostate cancer
- Metastatic castration-resistant prostate cancer
- Hormone-refractory metastatic prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Genzyme, a Sanofi Company
Industry Sponsor
David Meeker
Genzyme, a Sanofi Company
Chief Executive Officer since 2011
MD from the University of Vermont Medical School, Advanced Management Program at Harvard Business School
Jean-Paul Kress
Genzyme, a Sanofi Company
Chief Medical Officer since 2015
MD from Faculte Necker-Enfants Malades, Paris
Citations
The Efficacy of Cabazitaxel in Treating Prostate Cancer
Cabazitaxel, a second-generation taxane chemotherapy agent, has demonstrated efficacy in treating metastatic castration-resistant prostate cancer (mCRPC)
Survival outcomes based on line of therapy and treatment ...
Conclusions: Despite proven OS benefit, the overall utilization of cabazitaxel is low in real-world pts in the US. The number of pts with mCRPC ...
Current Evidence on Cabazitaxel for Prostate Cancer ...
A deeper understanding of PC biology, along with a comprehensive collection of real-world data, will be crucial to refining treatment strategies ...
Real-World Cabazitaxel Use and Outcomes in Metastatic ...
Cabazitaxel has demonstrated superior third line PFS and OS compared to androgen receptor pathway inhibitors (ARPIs) in patients who progress within 12 months ...
JEVTANA ® (cabazitaxel) injection: CARD Trial
Kaplan-Meier curve: Median OS of 13.6 months with JEVTANA + prednisone, n. At the cutoff date, 153 deaths were noted, with 70 deaths (54.3 ...
Real-world uptake, safety profile and outcomes of ...
Results: Of the 270 eligible patients, 103 received docetaxel (38.1%). 35 patients (34%) were hospitalised and there were 17 episodes of febrile neutropenia ( ...
Mortality Risk for Docetaxel-Treated, High-Grade Prostate ...
Thirty-one patients died, and of these deaths, 22 were due to prostate cancer. Performance status was 0 for 139 patients (95.9%) and 1 for 6 ...
Assessing the clinical outcomes of immunotherapy and ...
Assessing the clinical outcomes of immunotherapy and docetaxel combinations in metastatic castration-resistant prostate cancer: a meta-analysis.
Long-Term Outcomes of a Phase I Trial of Weekly ...
This regimen produced a 10-year overall survival of 68% with a 10-year metastasis-free survival of 58%. Grade >2 toxicity was minimal.
The Randomized Phase III NRG Oncology RTOG 0521 Trial
CT with docetaxel improved OS from 89% to 93% at 4 years, with improved disease-free survival and reduction in the rate of distant metastasis.
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