Is NCT05873192 recruiting in Houston, TX?

Yes, NCT05873192 is currently recruiting participants at its Houston, TX location. This prostate cancer clinical trial is actively enrolling qualified participants.

How do I join the prostate cancer clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Prostate Cancer Clinical Trial in Houston, TX

Who Can Participate

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.

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 provided.

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 peripheral blood smear; adequate hepatic function defined with a total bilirubin of ≤1.5 x upper limit of normal (ULN) (≤3 × ULN in subjects with Gilbert's disease), and AST/ALT ≤2.5 x ULN; adequate renal function defined as creatinine \<1.5 x ULN or creatinine clearance ≥30 mL/min (measured or calculated with the Cockcroft-Gault Equation).

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 definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate.

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 with scheduled visits, treatment plans, laboratory tests, and other study procedures.

All patients must have a surgical and medical oncology consult prior to signing informed consent.

Exclusion Criteria

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.

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 other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).

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 pulmonary embolism in the 6 months prior to randomization.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT05873192) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Prostate Cancer Treatment Options in Houston, TX

If you're searching for prostate cancer treatment options in Houston, TX, this clinical trial (NCT05873192) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced prostate cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all prostate cancer clinical trials near you to find additional studies recruiting in your area.

Prostate Cancer Clinical Trial in Houston, TX

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About This Prostate Cancer Study in Houston