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New treatment option for Prostate Cancer
Official title Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
ClinicalTrials.gov ID: NCT05873192
What this study is testing
What is ADT?
ADT is an investigational medicine, being studied as a potential treatment for prostate cancer.
Also referred to as Hormone Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patients with adenocarcinoma of the prostate that in the opinion of the urologist could be resected after response to systemic therapy. Ductal...
- Patients must be regarded as acceptable surgical risk and confirm their intention to undergo radical prostatectomy at the end of the pre-surgical...
- 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.
You likely can't join if
- 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...
- Gastrointestinal abnormalities such as inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures...
- 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...
See the full eligibility criteria
Who can join
- 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...
- Patients must agree to tissue collection for correlative studies at the specified timepoints. At the study entry, any previously collected diagnostic tumor biopsy blocks from primary and/or metastatic tissues must be...
- Patients must have adequate bone marrow function defined as hemoglobin ³10 g/dL, an absolute peripheral neutrophil count (ANC) of ≥1,500/mm3 and platelet count of ≥100,000/mm3; no features suggestive of MDS/AML on...
- Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry.
- Patients or their partners must be surgically sterile or must agree to use one highly method or two effective methods of contraception while receiving study treatments and for at least 4 months thereafter. The...
- Patients must sign the current IRB approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution, and willing and able to comply...
- All patients must have a surgical and medical oncology consult prior to signing informed consent.
What rules you out
- 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...
- 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...
- 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.
- Patients with any infectious process that, in the opinion of the investigator, could worsen or its outcome be affected as a result of the investigational therapy.
- Patients with active or symptomatic viral hepatitis or chronic liver disease.
- Patients with active pneumonitis or extensive bilateral lung disease of non-malignant etiology.
- Patients with seizures or known condition that may pre-dispose to seizures (e.g., prior stroke or transient ischemic attack within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or...
- Patients with symptomatic congestive heart failure, unstable angina or myocardial infarction, coronary/peripheral artery bypass graft or repair, clinically significant ventricular arrhythmias, deep vein thrombosis or...
- Persistently uncontrolled diabetes mellitus or HIV infection.
- Inadequately controlled hypertension (defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>95 mmHg) despite antihypertensive medication, or prior history of hypertensive encephalopathy.
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- Anticipation of need for major surgical procedure during the course of the study other than as outlined by the protocol.
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to randomization.
- Overt psychosis, mental disability, otherwise incompetent to give informed consent, or history of non-compliance.
- Planned participation in any other experimental drug study.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.