Cabazitaxel plus prednisone for Hormone-Refractory Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hormone-Refractory Prostate CancerCabazitaxel plus prednisone - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Hormone-Refractory Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: hrough study completion, an average of 1 year

Year 1
Duration of tumor response
Year 1
Overall Survival
PSA response rate at 6 and 12 months
Pain response: BPI-SF pain intensity item scores
Radiological progression-free survival (rPFS)
Time to PSA progression (TTPP)
Time to Pain progression
Tumor response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Docetaxel plus prednisone
1 of 2
Cabazitaxel plus prednisone
1 of 2

Active Control

Experimental Treatment

214 Total Participants · 2 Treatment Groups

Primary Treatment: Cabazitaxel plus prednisone · No Placebo Group · Phase 2

Cabazitaxel plus prednisone
Drug
Experimental Group · 1 Intervention: Cabazitaxel plus prednisone · Intervention Types: Drug
Docetaxel plus prednisone
Drug
ActiveComparator Group · 1 Intervention: Docetaxel plus prednisone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: hrough study completion, an average of 1 year

Who is running the clinical trial?

Genzyme, a Sanofi CompanyIndustry Sponsor
521 Previous Clinical Trials
85,230 Total Patients Enrolled
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
326 Previous Clinical Trials
111,431 Total Patients Enrolled
fred Saad, MDPrincipal InvestigatorCHUM

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically or cytologically confirmed prostate adenocarcinoma.
You must have a PSA value of at least 2 ng/mL at study entry.
You have a low testosterone level.
You have metastatic disease.