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 range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Patients must be regarded as acceptable surgical risk and confirm their intention to undergo radical prostatectomy at the end of the pre-surgical therapy.
. ECOG performance status 2 or better.
. All patients must have tumor staging and meet at least one of the following criteria:
. Either lymph node biopsy or lymph node dissection demonstrating lymph node metastasis by prostate cancer.
. 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\*.
. The 2018 AJCC staging system will be followed.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 with biopsy-proven small cell or sarcomatoid histology.
. Patients with clinical or radiological evidence of bone or other extranodal metastasis.
. Patients who have had prior chemotherapy, experimental agents for prostate cancer, or patients receiving \>4 weeks of prior ADT will be excluded.
. 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.
. 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.
. History or current diagnosis of MDS/AML, and/or history of any malignancy \[other than the one treated in this study\] which has a ≥ 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).
. Known hypersensitivity to recombinant proteins, or any excipient contained in the drug formulation for talazoparib and/or enzalutamide.
. Congenital long QT syndrome or Electrocardiogram (ECG) at screening with QT interval corrected using Fridericia's formula (QTcF) \> 500 milliseconds.