Actively Recruiting
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
Led by City of Hope Medical Center · Updated on 2026-01-28
70
Participants Needed
1
Research Sites
328 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of talazoparib with androgen deprivation therapy and abiraterone in treating castration sensitive prostate cancer patients. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Androgen can cause the growth of prostate tumor cells. Degarelix, leuprolide acetate, bicalutamide, goserelin acetate, and abiraterone lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Giving talazoparib with androgen deprivation therapy and abiraterone may improve cancer control for patients with castration sensitive prostate cancer.
CONDITIONS
Official Title
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with adenocarcinoma of the prostate confirmed by biopsy or cytology
- Have metastatic prostate cancer involving soft tissue and/or bone before starting androgen therapy
- Underwent baseline imaging within 42 days before or 14 days after starting LHRH therapy
- Started LHRH therapy no more than 60 days before registering for the study
- Karnofsky performance status between 60 and 100
- Agree to use effective contraception or abstain from intercourse during and for 4 months after treatment if of reproductive potential
- Bilirubin levels less than or equal to 2 times the upper limit of normal (ULN)
- Liver enzymes (AST and ALT) less than or equal to 2.5 times ULN, or up to 5 times ULN if liver metastases are present
- Creatinine clearance of at least 30 mL/min
- Leukocytes count of at least 3,000/mcL
- Absolute neutrophil count (ANC) of at least 1,500/mcL
- Hemoglobin level of 9 g/dL or higher
- Platelet count of at least 100,000/mcL
- Able to understand and willing to sign informed consent
- Prior androgen deprivation therapy (ADT) allowed if it lasted no more than 36 months and ended at least 6 months ago with serum testosterone above 150 ng/mL
- May have received palliative radiotherapy for bone or visceral metastasis if fully recovered
- May have had surgery with at least 14 days recovery from side effects
- May receive bone targeting agents that do not affect PSA levels (e.g., denosumab or bisphosphonate)
You will not qualify if you...
- Have received or plan to receive ketoconazole, aminoglutethimide, or enzalutamide; megestrol for hot flashes is allowed
- Have received prior cytotoxic chemotherapy for metastatic prostate cancer, except possibly curative chemotherapy completed at least 2 years ago
- Have known brain metastases or neurological symptoms suggesting brain metastases
- Have New York Heart Association class III or IV heart failure
- Had thromboembolic events, unstable angina, myocardial infarction, or serious uncontrolled arrhythmia within 6 months
- Have uncontrolled high blood pressure despite medication
- Have HIV infection, active chronic hepatitis B or C, or any serious unrelated medical or psychiatric illness
- Have primary or secondary adrenal insufficiency
- Have allergies to study drug compounds
- Receiving other investigational agents or concurrent biological, chemotherapy, or radiation therapy
- Have gastrointestinal disease or procedures interfering with drug absorption or swallowing
- Have other prior malignancies except adequately treated skin cancer, stage I or II cancer in remission, or disease-free cancer for 5 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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