Combo Chemotherapy for Prostate Cancer

Recruiting at 7 trial locations

Overseen By Emmanuel Antonarakis, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Masonic Cancer Center, University of Minnesota

Must be taking: ADT

Must not be taking: Chemotherapy, PARPi, Immunotherapy

Disqualifiers: Active second malignancy, Severe psychiatric illness, 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

22 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Emmanuel Antonarakis, MD

Principal Investigator

Masonic Cancer Center, University of Minnesota

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Treatment

Participants receive a combination of ADT, carboplatin, and cabazitaxel for 6 cycles

18 weeks

Abiraterone Treatment

Participants start abiraterone with ADT after completing chemotherapy

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone
• Cabazitaxel
• Carboplatin
• Prednisone

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.

How Is the Trial Designed?

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

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?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+