Actively Recruiting
Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with adenocarcinoma of the prostate considered resectable after systemic therapy, including ductal adenocarcinoma.
- Acceptable surgical risk and intent to undergo radical prostatectomy after pre-surgical therapy.
- ECOG performance status of 2 or better.
- Tumor staging showing lymph node metastasis by biopsy or dissection, or non-bulky regional/distant lymphadenopathy on imaging with biopsy confirmation if needed.
- Prior hormonal therapy up to 6 weeks allowed if biopsy before ADT is available; first-generation antiandrogens discontinued before randomization.
- Agreement to tissue collection for correlative studies and provision of previous diagnostic biopsy blocks.
- Adequate bone marrow, liver, and kidney function as specified.
- Medications lowering seizure threshold discontinued or substituted at least 4 weeks before study entry.
- Patients or partners surgically sterile or agree to use effective contraception during treatment and 4 months after.
- Signed informed consent and willingness to comply with study procedures.
- Surgical and medical oncology consult completed before consent.
You will not qualify if you...
- Patients with biopsy-proven small cell or sarcomatoid prostate cancer.
- Evidence of bone or other extranodal metastasis.
- Prior chemotherapy, experimental prostate cancer agents, or more than 4 weeks of prior ADT.
- Treatment with estrogens, cyproterone acetate, or high-dose glucocorticoids within 4 weeks before treatment start.
- Gastrointestinal conditions preventing oral medication or causing malabsorption.
- History or current diagnosis of MDS/AML or other malignancy with high recurrence risk within 24 months (except certain treated cancers).
- Known allergy to talazoparib, enzalutamide, or their components.
- Congenital long QT syndrome or ECG QTcF > 500 ms at screening.
- Active infections or conditions that could worsen with study treatment.
- Active viral hepatitis or chronic liver disease.
- Active pneumonitis or extensive non-malignant lung disease.
- Seizures or conditions predisposing to seizures.
- Significant heart conditions or recent thrombotic events within 6 months.
- Uncontrolled diabetes or HIV infection.
- Poorly controlled hypertension despite medication.
- Bleeding disorders without therapeutic anticoagulation.
- Planned major surgery during the study outside the protocol.
- Recent history of abdominal fistula or gastrointestinal perforation.
- Mental incapacity or history of non-compliance.
- Planned participation in other experimental drug studies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Amado Zurita-Saavedra, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here