Metastatic Castration-Resistant Prostate Cancer Treatment Study

Clinical Trial Title

A phase 3, randomized, double-blind, placebo-controlled study of talazoparib with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC).

National Clinical Trial Number:

NCT03395197

Clinical Trial Protocol Description:

This study will explore the safety and efficacy (how well it works) of an investigational drug, talazoparib, when added to enzalutamide, in patients with mCRPC.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features. If the patient does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and to support biomarker analysis.
  • Consent to a saliva sample collection for retrospective sequencing of the same DDR genes tested on tumor tissue, or a subset thereof, and to serve as a germline control in identifying tumor mutations.
  • Have been surgically or medically castrated, with serum testosterone 50 ng/dL (1.73 nmol/L) at screening. Or ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist for patients who have not undergone bilateral orchiectomy must be initiated at least 4 weeks before Day 1 (Part 1) or randomization (Part 2) and must continue throughout the study.
  • Have metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan. Scans obtained as part of standard of care in the 6 weeks (42 days) prior to Day 1 (Part 1) or randomization (Part 2) can be used if they meet study requirements. Measurable soft tissue disease is not required. (Adenopathy below the aortic bifurcation alone does not qualify.)

You will be excluded from the study if any of the following criteria apply to you:

  • Have had any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state.
  • Only evidence of metastasis is adenopathy below the aortic bifurcation.
  • Have had prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer.
  • Have had prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy within 6 months (from the last dose).

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Timothy Kuzel, MD

Contact Information

Rush Cancer Center Clinical Trials Office