Docetaxel vs Cabazitaxel for Prostate Cancer

(CABPOSTAAT Trial)

Overseen By Amal 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

Must not be taking: Antiretrovirals, Isotope therapy

Disqualifiers: Brain metastases, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until disease progression or unacceptable toxicity

57 Participants Needed

Trial Summary

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.

Research Team

fred Saad, MD

Principal Investigator

CHUM

Eligibility Criteria

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.

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;

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Cabazitaxel plus prednisone Experimental Treatment 1 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 prednisone Active Control 1 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

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

Approved in European Union as Jevtana for:

• Hormone refractory metastatic prostate cancer

Approved in United States as Jevtana for:

• Metastatic castration-resistant prostate cancer

Approved in Canada as Jevtana for:

• Hormone-refractory metastatic prostate cancer

Approved in Japan as Jevtana for:

• Prostate cancer

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

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