Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer (NCT05873192) | Clinical Trial Compass
RecruitingPhase 2
Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
United States30 participantsStarted 2025-06-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
â. Patients with adenocarcinoma of the prostate that in the opinion of the urologist could be resected after response to systemic therapy. Ductal adenocarcinoma is permitted.
â. Patients must be regarded as acceptable surgical risk and confirm their intention to undergo radical prostatectomy at the end of the pre-surgical therapy.
â. ECOG performance status 2 or better.
â. All patients must have tumor staging and meet at least one of the following criteria:
â. Either lymph node biopsy or lymph node dissection demonstrating lymph node metastasis by prostate cancer.
â. Non-bulky (\<5 cm) regional pelvic or distant lymphadenopathy visualized on CT/MRI/PET scan. Lymph node biopsy confirmation will be required if \<2.0 cm or in atypical distribution\*.
â. The 2018 AJCC staging system will be followed.
â. Prior hormonal therapy (LHRH agonist/antagonist with or without first-generation antiandrogen) up to 6 weeks is permitted, provided any tumor biopsy specimen collected prior to initiation of ADT is made available for biomarker studies. If patient was started on first-generation antiandrogens, these would be discontinued prior to randomization.
Exclusion criteria
â. Patients with biopsy-proven small cell or sarcomatoid histology.
â. Patients with clinical or radiological evidence of bone or other extranodal metastasis.
What they're measuring
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: Through study completion; an average of 1 year.
. Patients who have had prior chemotherapy, experimental agents for prostate cancer, or patients receiving \>4 weeks of prior ADT will be excluded.
â. Treatment with estrogens, cyproterone acetate or glucocorticoids (at a dose \>10 mg/day of prednisone equivalent) in the 4 weeks prior to scheduled Day 1 of treatment.
â. Gastrointestinal abnormalities such as inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection; active gastrointestinal bleeding as evidenced by hematemesis, hematochezia, or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; malabsorption syndromes.
â. History or current diagnosis of MDS/AML, and/or history of any malignancy \[other than the one treated in this study\] which has a ⼠30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or Ta urothelial carcinoma).
â. Known hypersensitivity to recombinant proteins, or any excipient contained in the drug formulation for talazoparib and/or enzalutamide.
â. Congenital long QT syndrome or Electrocardiogram (ECG) at screening with QT interval corrected using Fridericia's formula (QTcF) \> 500 milliseconds.