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Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase III
18 Years and older, Male
Study Type
Protocol IDs
Study Sponsor
Pfizer Inc


The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination
with enzalutamide compared with placebo in combination with enzalutamide in participants with
DDR-deficient mCSPC.


The study will have 5 periods: prescreening, screening, double-blind treatment, safety
follow-up, and long-term follow-up.

Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly
assigned to either of 2 treatment groups as follows:

- Talazoparib in combination with enzalutamide.

- Placebo capsules identical in appearance to talazoparib capsules in combination with

Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be
open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is
0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by
the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35
mg once daily.


  1. Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea).
  2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and may also be used to support biomarker analysis.
  3. Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or FoundationOne CDx.
  4. Willing to provide tumor tissue when available (de novo or archived) for retrospective molecular profiling analysis, if not already provided as part of inclusion criterion
  5. 5. Unless prohibited by local regulations or ethics committee decision, consent to a saliva sample collection for retrospective sequencing of the same DDR genes tested on tumor tissue and blood (liquid biopsy), or a subset thereof, and to serve as a germline control in identifying tumor mutations.
  6. Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before randomization and must continue throughout the study.
  7. Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue). Participants whose disease spread is limited to regional pelvic lymph nodes are not eligible. Note: a finding of superscan at baseline is exclusionary.
  8. Prior treatment of mCSPC with docetaxel is not permitted.
  9. Treatment with estrogens, cyproterone acetate, or first-generation anti-androgens is allowed until randomization.
  10. Other prior therapy allowed for mCSPC; =3 months of ADT (chemical or surgical) with or without approved NHT in mCSPC (ie, abiraterone + prednisone, apalutamide, or enzalutamide), if required prior to randomization, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.
  11. Participant may have received palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should have been completed at least 2 weeks prior to randomization. NOTE: Radical prostatectomy or definitive radiotherapy to the primary tumor for metastatic castration-sensitive prostate cancer with curative intent is not permitted.
  12. ECOG performance status 0 or 1.
  13. Adequate organ function within 28 days before the first study treatment on Day 1, defined by the following:
  14. ANC =1500/µL, platelets =100,000/µL, or hemoglobin =9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology laboratory tests at screening).
  15. Total serum bilirubin <1.5 × ULN (<3 × ULN for participants with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
  16. AST or ALT <2.5 × ULN (<5 × ULN if liver function abnormalities are due to hepatic metastasis).
  17. Albumin >2.8 g/dL.
  18. eGFR =30 mL/min/1.73 m2 by the MDRD equation.
  19. Sexually active participants that in the opinion of the investigator are capable of ejaculating, must agree to use a condom when having sex with a partner (female or male) from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide). Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib / placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide) when having sex.
  20. Must agree not to donate sperm from the first dose of study treatment to 4 months after the last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide).
  21. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including being able to manage electronic diaries. The PRO assessments are not required to be completed if a patient does not understand the language(s) available for a specific questionnaire and/or cannot complete the specific questionnaire independently.
  22. Capable of giving signed informed consent.
  23. For France only: Participants affiliated with the social security system or beneficiaries of an equivalent system.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell

1700 Hospital South Drive
Suite 300
Austell, GA 30106


Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen

200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110


Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton

157 Clinic Avenue
Suite 101
Carrollton, GA 30117


Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville

100 Market Place Boulevard
Suite 200
Cartersville, GA 30121


Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville

6002 Professional Parkway
Suite 220
Douglasville, GA 30134


Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper

1020 J.L. White Drive
Suite 160
Jasper, GA 30143


Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta

340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060

Northwest Georgia Oncology Centers - Paulding

144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141


Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica

705 Dallas Highway
Suite 204
Villa Rica, GA 30180


Randall E. Pierce MD
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