RecruitingPhase 2NCT05616650

Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor

A Phase II Trial of Focal Ultrahypofractionated Stereotactic Radiation Therapy for the Treatment of Unifocal Prostate Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

42 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a highly targeted radiation technique called SBRT (stereotactic body radiation therapy) can effectively treat a single, localized prostate cancer tumor while sparing the rest of the prostate — an approach known as focal therapy. **You may be eligible if...** - You are 18 or older with low or intermediate risk prostate cancer confirmed by biopsy - Your cancer appears as a single tumor on both MRI and a PSMA PET/CT scan, confirmed by a targeted biopsy - Your general health score is 0–2 and you do not have severe urinary symptoms **You may NOT be eligible if...** - Your cancer is high risk (Gleason score 8 or above, or PSA of 20 or higher) - There is cancer in areas of the prostate outside the visible tumor - You have cancer that has spread to the pelvis or elsewhere - You have previously had curative treatment for prostate cancer - You are also receiving hormone therapy or chemotherapy - Your urinary symptom score is high Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-DCFPyL

Each participant will receive a single IV dose of 18F-DCFPyL by bolus injection. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi; dose variations will be in accordance with the Nuclear Regulatory Commission (NRC) standard dose variation (i.e., 20%) permitted for diagnostic clinical studies.

RADIATIONStereotactic Body Radiation Therapy

Intensity modulated radiotherapy will be delivered to a dose of 26Gy in two fractions with the second fraction performed within 8 days of the first session.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05616650


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