Is NCT05616650 recruiting in Bethesda, MD?

Yes, NCT05616650 is currently recruiting participants at its Bethesda, MD location. This prostatic neoplasms clinical trial is actively enrolling qualified participants.

How do I join the prostatic neoplasms clinical trial in Bethesda?

To join this clinical trial in Bethesda, 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 Bethesda 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.

Prostatic Neoplasms Clinical Trial in Bethesda, MD

About This Prostatic Neoplasms Study in Bethesda

Background: The current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments. Objective: To see how people with untreated localized prostate cancer will respond to focal therapy with SBRT. Eligibility: People aged 18 years and older with untreated localized prostate cancer (prostate cancer which has not spread outside of the prostate gland). Design: * Participants will undergo screening including blood tests, an MRI, a PSMA PET/CT (18F-DCFPyL), and a biopsy. * Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and/or around the tumor to help target the radiation treatment. * Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards. * Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET/CT) and blood (PSA) tests. * After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation is required).

Unifocal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET/CT imaging which is correlated with a positive targeted biopsy.

Age \>=18 years.

ECOG performance status \<=2 (Karnofsky \>60%).

Men must agree to use highly effective contraception with their partner (barrier method of birth control; abstinence) for the duration of study participation and up to 120 days after the last radiation treatment.

Ability of individual to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Participants with NCCN high-risk prostate cancer features (Gleason score \>=8, \>cT2c, or PSA \>= 20 ng/mL).

Participants with prostate biopsies which show \>= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion (systematic biopsies which map to a radiographically detected lesion are not an exclusion criterion).

Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.

Participants who are receiving any other investigational agents.

Participants found to have pelvic or distant metastases on pre-treatment staging studies.

Participants with an AUA-SI/IPSS score \> 18.

Participants who have previously received curative treatment for a prior or the current diagnosis of prostate cancer.

Active urinary tract infection assessed by urinalysis.

Human immunodeficiency virus (HIV)-infected individuals who are not on effective anti-retroviral therapy. Participants on anti-retroviral therapy with undetectable viral load within the 6 months prior to registration are eligible for this trial.

Participants with hepatitis B virus (HBV) infection who have not been treated and cured.

Participants with chronic HBV at screening must have an undetectable HBV viral load on suppressive therapy.

Participants with hepatitis C virus (HCV) infection who have not been treated and cured.

Participants with HCV infection who are currently on treatment, are eligible if they have an undetectable HCV viral load at screening.

Anatomic relationship between the tumor and adjacent normal tissues judged to be unfeasible for the planned treatment by the PI.

Participants with connective tissue diseases.

Participants with radiation hypersensitivity syndromes.

Ongoing active inflammatory bowel disease within the radiation field.

Participants with prior medical comorbidity or surgical history involving the low pelvis which is expected to confer a high risk of toxicity to the experimental radiation regimen.

Ineligibility or unwillingness to undergo a contrast-enhanced MRI due to inadequate renal function (eGFR \< 30), severe claustrophobia, a weight above tolerance of the scanner (\> 350 lbs.), a body size unable to fit into the scanner, or implanted devices incompatible with an MRI (implanted cardiac devices, surgical hardware, retained shrapnel, cerebral aneurysm clips, or other incompatible objects.

Unwillingness to undergo an 18F-DCFPyL PET/CT or known allergy to the 18F-DCFPyL tracer.

Contraindication or inability to undergo fiducial marker implantation.

History of prior radiotherapy overlapping with the intended radiation field.

Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements.

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 Bethesda?

Yes, this clinical trial (NCT05616650) has an active research site in Bethesda, MD 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.

Prostatic Neoplasms Treatment Options in Bethesda, MD

If you're searching for prostatic neoplasms treatment options in Bethesda, MD, this clinical trial (NCT05616650) 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 Bethesda research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced prostatic neoplasms 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 prostatic neoplasms clinical trials near you to find additional studies recruiting in your area.

Prostatic Neoplasms Clinical Trial in Bethesda, MD

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