57 Participants Needed

Docetaxel vs Cabazitaxel for Prostate Cancer

(CABPOSTAAT Trial)

Recruiting at 1 trial location
AN
Overseen ByAmal Nadiri, PhD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.

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.12345

Why 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.

Who Is on the Research Team?

fS

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

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.
See 7 more

Exclusion Criteria

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.
- AST/SGOT and/or ALT/SGPT >1.5 x ULN;
See 28 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cabazitaxel plus prednisone or docetaxel plus prednisone until disease progression, unacceptable toxicity, or refusal of further treatment

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cabazitaxel plus prednisoneExperimental Treatment1 Intervention
Group II: Docetaxel plus prednisoneActive Control1 Intervention

Cabazitaxel is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Jevtana for:
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Approved in United States as Jevtana for:
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Approved in Canada as Jevtana for:
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Approved in Japan as Jevtana for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Genzyme, a Sanofi Company

Industry Sponsor

Trials
528
Recruited
186,000+
David Meeker profile image

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 profile image

Jean-Paul Kress

Genzyme, a Sanofi Company

Chief Medical Officer since 2015

MD from Faculte Necker-Enfants Malades, Paris

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/28940952/
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 TrialCT 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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