Combo Chemotherapy for Prostate Cancer

Recruiting at7 trial locations

Overseen by Emmanuel Antonarakis, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Masonic Cancer Center, University of Minnesota

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression-free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.

Research Team

Emmanuel Antonarakis, MD

Principal Investigator

Masonic Cancer Center, University of Minnesota

Eligibility Criteria

Men over 18 with advanced prostate cancer that has spread, and who have started hormone therapy within the last 3 months. They must be in good physical condition (able to perform daily activities without assistance), have not had chemotherapy or certain other treatments for prostate cancer, and agree to use contraception.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.

I have been on hormone therapy for prostate cancer for 3 months or less.

Exclusion Criteria

PSA <2.0 ng/mL at diagnosis.

I haven't had prostate cancer treatment in the last 28 days or 5 half-lives, except for anti-androgens.

I have taken abiraterone or enzalutamide for less than 2 weeks.

Treatment Details

Interventions

• Abiraterone (Hormone Therapy)
• Cabazitaxel (Anti-tumor antibiotic)
• Carboplatin (Alkylating agents)
• Prednisone (Hormone Therapy)

Trial Overview The trial is testing a combination of chemotherapy drugs (carboplatin and cabazitaxel) followed by abiraterone in men with metastatic prostate cancer sensitive to hormone therapy. The goal is to see if this treatment can stop the disease from progressing after one year.

Participant Groups

Group I: Carboplatin, Cabazitaxel and Abiraterone Experimental Treatment 4 Interventions

Cabazitaxel is already approved in Canada, Japan for the following indications:

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?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

Dr. Melissa A. Geller

Masonic Cancer Center, University of Minnesota

Chief Medical Officer since 2022

MD from University of Minnesota

Dr. Jeffrey Miller

Masonic Cancer Center, University of Minnesota

Chief Executive Officer

MD from University of Minnesota