NCT03253744CompletedPhase 1

Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Source: ClinicalTrials.gov · Last updated 8 Oct 2025

Brief summary (registry, in English)

Background: Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT). Objective: To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation. Eligibility: Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease. Design: Participants will be screened with blood tests, physical exam, and medical history. They may also have: Magnetic resonance imaging (MRI) scan of the prostate. Positron emission tomography (PET)/computed tomography (CT) scan. Participants will get an injection of 2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) for the PET scan. They will lie very still on their back on the scanner table. Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation. About 2 weeks later, participants will have a radiation treatment planning CT scan. Participants will answer questions about their urine function, bowel function, erectile function, and mood. Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks. Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires. Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated. Participants will continue to have routine visits until two years after treatment is completed....

Status (registry): Completed
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 17 (actual)
First submitted: 17 Aug 2017
Start date: 5 Jul 2018
Primary completion date: 3 May 2023
Lead sponsor: National Cancer Institute (NCI)
Diseases: Prostate cancer
NCT number: NCT03253744

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 17
From 5 Jul 2018 to the primary completion date, 3 May 2023
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Patients who are receiving any other investigational agents.
PSA greater than or equal to 20 ng/dL if no prior 2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) scan obtained (If PSA \> 20 and 18F-DCFPyL obtained within 3 months prior to enrollment shows no evidence of metastatic disease, subjects may be included in the study)
Biochemical recurrence within one year of completion of radiotherapy
Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
Prior prostatectomy
Patients with positive Human Immunodeficiency Virus (HIV) status and currently requiring treatment with agents known to sensitize to irradiation, such as protease inhibitors.

Other illness

Inflammatory bowel disease
Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion)
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Other medical conditions deemed by the Principal Investigator (or associates) to make the subject unsafe or ineligible for protocol procedures

Lab values

Serum creatinine \> 2 times the upper limit of normal
Total bilirubin \> 2 times the upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin \> 3.0.
Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 3 times the upper limit of normal

Other

Active Lupus or Active scleroderma
Subjects with severe claustrophobia that is unresponsive to oral anxiolytics
Subjects weighing \> 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry

Criteria the registry did not label

INCLUSION CRITERIA:
Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (external beam radiation therapy (EBRT) or brachytherapy).
Prostate-specific antigen (PSA) failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least 2 nanograms (ng) per deciliter (dL) above post-radiotherapy nadir)
Age greater than or equal to 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
Ability of subject to understand and the willingness to sign a written informed consent document.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.