Is NCT04947254 recruiting in Houston, TX?

Yes, NCT04947254 is currently recruiting participants at its Houston, TX location. This prostate carcinoma clinical trial is actively enrolling qualified participants.

How do I join the prostate carcinoma 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 Carcinoma Clinical Trial in Houston, TX

About This Prostate Carcinoma Study in Houston

This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Completion of informed consent prior to any study specific procedures. Consent may be done remotely.

Patients must agree to tissue collection for correlative studies at the specified timepoints

Male aged 18 years and above

Histologically or cytologically confirmed prostate carcinoma

Localized or regional high-risk disease as defined by at least one of the following features: Prostate specific antigen (PSA) \> 20 ng/mL, T3a or higher, grade group 4-5 (i.e. Gleason score ≥ 8) as per National Comprehensive Cancer Network (NCCN) Prostate Cancer Version 2.2020 for high risk or very high risk prostate cancer, and/or regional lymph nodes positive for prostate cancer

Planned for definitive treatment of local regional prostate cancer using XRT and androgen ablation

Willing to undergo ongoing medical castration to maintain testosterone levels of ≤ 50 ng/dL (≤ 2.0 nM) throughout systemic treatment or have undergone bilateral orchiectomy

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below:

Hemoglobin ≥ 10.0 g/dL

Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L

White blood cells (WBC) \> 3 x 10\^9/L

No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear

Platelet count ≥ 100 x 10\^9/L

Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease). (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.)

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x institutional upper limit of normal

Calculated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 mL/min

Serum Albumin ≥ 3.0

Serum potassium ≥ 3.5 mmol/L

Able to swallow study drugs whole as a tablet/capsule

Patients who have partners of childbearing potential (e.g. female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use two methods of birth control including adequate barrier protection during the study and for 4 months after last dose of niraparib, abiraterone acetate, and/or apalutamide administration. In addition men should not donate sperm during this period. Please note that the efficacy of hormonal contraception may be decreased if administered with niraparib, abiraterone acetate, and/or apalutamide

Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry

Exclusion Criteria

Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment. Any prior PARP inhibitor therapy

Patients who have prostate cancer with distant metastatic disease

Patients who have had prior major surgery (prostatectomy) or radiotherapy for the treatment of prostate cancer

Any unresolved toxicity (Common Terminology Criteria for Adverse Events \[CTCAE\] grade ≥ 2) from previous anti-cancer therapies

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 carcinomas)

Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the principal investigator \[PI\]; the PI will serve as the final arbiter regarding eligibility)

Active or symptomatic viral hepatitis or chronic liver disease

Active pneumonitis or extensive bilateral lung disease of non-malignant etiology

Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples include, but are not limited to superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (HRCT) scan, uncontrolled seizures, history of allogeneic organ transplant, history of primary immunodeficiency or any psychiatric disorder that prohibits obtaining informed consent

Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of study medication

Patients with a known hypersensitivity to niraparib, apalutamide, and/or abiraterone acetate

Prisoners or subjects who are involuntarily incarcerated

Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness

Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy)

Severe or unstable angina, myocardial infarction (within 6 months prior to enrollment), symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), uncontrolled hypertension, or clinically significant ventricular arrhythmias within 6 months prior to randomization

Current evidence of any of the following:

Gastrointestinal disorder affecting absorption

Active uncontrolled infection (e.g., human immunodeficiency virus \[HIV\] or viral hepatitis)

Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily

Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency

Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate

Baseline moderate and severe hepatic impairment (Child-Pugh class B \& C)

Any condition that in the opinion of the investigator, would preclude participation in this 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 (NCT04947254) 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 Carcinoma Treatment Options in Houston, TX

If you're searching for prostate carcinoma treatment options in Houston, TX, this clinical trial (NCT04947254) 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 carcinoma 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 carcinoma clinical trials near you to find additional studies recruiting in your area.

Prostate Carcinoma Clinical Trial in Houston, TX

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