Talazoparib + Enzalutamide for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAmado Zurita-Saavedra, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.

Eligibility Criteria

Men with prostate cancer that has spread to lymph nodes can join this trial if they're in good enough health for surgery, have not had certain other treatments or conditions, and agree to use contraception. They must also be willing to provide tissue samples and follow the study's procedures.

Inclusion Criteria

I am considered fit for surgery and plan to have a radical prostatectomy after pre-surgery treatment.

I've had hormone therapy for up to 6 weeks and can provide a tumor sample from before starting it.

My prostate cancer is considered removable after treatment, including ductal adenocarcinoma.

+11 more

Exclusion Criteria

My cancer is confirmed to be small cell or sarcomatoid through a biopsy.

My cancer has spread to my bones or other areas beyond the original site.

Planned participation in any other experimental drug study.

+17 more

Participant Groups

The trial is testing how well talazoparib works when added to standard hormone therapy (ADT) and enzalutamide before surgery in men with prostate cancer. It aims to see if this combination helps reduce the cancer more effectively.

1Treatment groups

Experimental Treatment

Group I: ADT plus Enzalutamide plus TalazoparibExperimental Treatment5 Interventions

Participant will recive ADT plus Enzalutamide for a total of 8 weeks. After about 8 weeks of ADT and Enzalutamide treatment, participant will begin taking Talazoparib

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

🇺🇸 Approved in United States as Xtandi for: