Is NCT06066437 recruiting in Houston, TX?

Yes, NCT06066437 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

About This Prostate Cancer Study in Houston

To learn if the proposed dose of 177Lu rhPSMA-10.1 is safe. Phase 2 will open if the Phase 1 dose is found to be safe. To learn about the safety and effects of 177Lu rhPSMA-10.1 alone and with androgen deprivation therapy (ADT) on patients with high-risk, localized prostate cancer before they have surgery to remove the disease.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Men ≥18 years of age

Histologically documented prostatic adenocarcinoma with an NCCN risk group of high-risk or very high-risk. NCCN High Risk and Very High-Risk criteria shown below. (Network, N.C.C. (2021). Prostate Cancer (Version 02.2021). High Risk:

Has no very-high-risk features and has exactly one high-risk feature:

Grade Group 4 or Grade Group 5

PSA \>20 ng/mL Very high:

Has at least one of the following:

Primary Gleason pattern 5

2 or 3 high-risk features

\>4 cores with Grade Group 4 or 5

Prostate biopsy within 90 days prior to randomization is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible

ECOG performance status (PS) grade 1

No evidence of metastatic disease or clinically positive lymph nodes as documented by technetium99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to randomization

Minimum prostate tumor volume of 1.5 cm3 or greater as measured on prostate MRI within 60 days prior to randomization

Distant metastatic disease or clinically positive lymph nodes not identified by conventional imaging including by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans but identified PSMA PET is allowed based on provider discretion

PSMA expression within the primary tumor with a minimum SUVmax of the primary tumor of at least 8

Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for and plan to undergo radical prostatectomy and 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

Adequate bone marrow function documented by:

Hemoglobin ≥11 g/dL

Absolute neutrophil count ≥1.5 x 109/L

Platelet count ≥150 x 109/L

Adequate renal function defined as creatinine \<1.5 x ULN or estimated glomerular filtration rate \>60 mL/min/1.73 m2 using BSA with CKD-EPI

Adequate hepatic function documented by:

Total bilirubin ≤1.5 x ULN

AST ≤2.5 x ULN

ALT ≤2.5 x ULN

Alkaline Phosphatase (ALP) ≤2.5 x ULN 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

Consents to providing whole blood samples for correlative PSMA evaluation of circulating tumor cells and extra cellular vesicles

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 6 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-α reductase inhibitors allowed), or 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.

Known evidence of an active infection requiring systemic therapy such as uncontrolled human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Uncomplicated urinary tract infection (UTI) does not qualify as an excluding infection.

Patients with HIV must be on an effective anti-retroviral regimen atleast four weeks prior to enrollment, HIV viral load less than 400 copies/mL and CD4+ T cell counts greater than 350 cell/uL.

Patients with HIV must agree to adhere to anti-retroviral therapy for the entirety of their participation in the protocol unless dictated by treatment toxicities.

Patients on Tenofovir will be excluded as there is a known risk of proximal renal tubule dysfunction leading to renal toxicity. Given that PSMA is expressed on the proximal tubule there is a theoretical risk of overlapping toxicity.

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)

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 90 days of first administration of study drug

Prior allogeneic stem cell transplantation or recipients of organ transplants or autologous stem cell transplantation at any time MD Anderson Protocol Number: 2022-0500 2022-0500 Version Date 8/29/2023 26

Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study

Previously received external beam irradiation to the pelvis or to a field that includes more than 30% of the bone marrow or kidneys

Previous treatment with any of the following: PSMA-targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation

Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical trial

Patient has a functionally or anatomically solitary kidney.

Patients with Hydronephrosis and a Mag3 Lasix Renogram that demonstrates objective urinary obstruction.

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 (NCT06066437) 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 (NCT06066437) 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 phase 1/2 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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