Houston, TXNCT06085664Now EnrollingIRB Ready

Prostate Cancer Clinical Trial in Houston, TX

Access cutting-edge prostate cancer treatment through this clinical trial at a research site in Houston. Study-provided care at no cost to qualified participants.

Sponsored by M.D. Anderson Cancer Center

Quick Self-Assessment

See if you qualify for this Houston location

Preparing your pre-screening questions…

Expert Care in Houston

Access prostate cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related prostate cancer treatment provided free

Apply for This Houston Location

Check if you qualify for this prostate cancer clinical trial in Houston, TX

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Houston

    Convenient for TX residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Houston site if eligible
  4. 4Begin participation

About This Prostate Cancer Study in Houston

To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Men ≥ 18 years of age
Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas or mixed histologies are not eligible
Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1
No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to enrollment
Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection
No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate \[TURP\]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy
Hemoglobin ≥ 11 g/dL
Absolute neutrophil count ≥ 1.5 x 10\^9/L
Platelet count ≥ 100 x 10\^9/L
Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate \> 50 mL/min/1.73 m\^2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria
Total bilirubin ≤ 1.5 x ULN
NOTES: Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as past medical history
Aspartate aminotransferase (AST) ≤ 2.5 x ULN
Alanine aminotransferase (ALT) ≤ 2.5 x ULN
Alkaline phosphatase (ALP) ≤ 2.5 x ULN
Consent to MD Anderson laboratory protocol PA13-0291
Willing and able to comply with clinic visits and study-related procedures
Provide informed consent signed by study patient
To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug

Exclusion Criteria

Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Currently enrolled in another interventional study
Concurrent treatment with systemic corticosteroids (prednisone dose \> 10 mg per day or equivalent) or other immunosuppressive drugs \< 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted
History of or known or suspected autoimmune disease (exception\[s\]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed)
Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Patients with known HIV infection which is well-controlled (undetectable viral load by HIV ribonuclecid acid \[RNA\] polymerase chain reaction \[PCR\]) and CD4 counts greater than 350 are permitted to participate
History of clinically significant cardiovascular disease including, but not limited to:
Myocardial infarction or unstable angina ≤ 6 months prior to treatment initiation
Clinically significant cardiac arrhythmia
Deep vein thrombosis, pulmonary embolism, stroke ≤ 6 months prior to treatment initiation
Congestive heart failure (New York Heart Association class III-IV)
Pericarditis/clinically significant pericardial effusion
Myocarditis
Endocarditis
History of major implant(s) or device(s), including but not limited to:
Prosthetic heart valve(s)
Artificial joints and prosthetics placed ≤ 12 months prior to treatment initiation
Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed
Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤ 2 years prior to enrollment
Has received major surgery within 14 days of first administration of study drug
Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living \[ADLs\]) or uncontrolled seizures in the year prior to first dose of study therapy
Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (past 5 years)
Receipt of a live vaccine within 4 weeks of planned start of study medication
Prior allogeneic stem cell transplantation or recipients of organ transplants at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment
Any medical, psychological or social 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 (NCT06085664) 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 (NCT06085664) 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.

More Prostate Cancer Trials in Houston, TX

See all prostate cancer clinical trials recruiting in Houston — not just this study.

Browse Prostate Cancer Trials in Houston

Browse More Trials by Condition

Ready to Join in Houston?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Houston, TX