57 Participants Needed

Docetaxel vs Cabazitaxel for Prostate Cancer

(CABPOSTAAT Trial)

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 tests if cabazitaxel plus prednisone can help patients with advanced prostate cancer that hasn't responded to other treatments. Cabazitaxel stops cancer cells from growing, and prednisone helps manage side effects. Cabazitaxel was approved by the US FDA after a previous study showed improved survival in patients who had previously been treated with another medication.

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

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