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NCT05616650 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
42
Enrollment target
1
Study location

NCT05616650 is a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05616650, a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
42 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Prostate Cancer Prostate Adenocarcinoma Prostatic Neoplasms

Interventions

  • RADIATION Stereotactic Body Radiation Therapy
  • DRUG 18F-DCFPyL

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2023-10-19
Est. Completion 2028-12-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05616650

The ClinicalTrials.gov registry entry for NCT05616650 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic Body Radiation Therapy is the first listed.

NCT05616650 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT05616650 about?

NCT05616650 is a clinical study titled "Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor". 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 p...

What is the current status of trial NCT05616650?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2023-10-19. Estimated completion is 2028-12-01.

What conditions does trial NCT05616650 study?

This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms.

What interventions are being tested in trial NCT05616650?

The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), 18F-DCFPyL (DRUG).

Who is sponsoring clinical trial NCT05616650?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05616650 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.