Second-Chance radiation: new hope for recurrent prostate cancer?
NCT ID NCT03253744
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a highly targeted type of radiation (SBRT) in 17 men whose prostate cancer returned after prior radiation. The goal was to find the highest safe dose and see how well the body tolerated it. Participants received five focused treatments over two weeks, and researchers monitored side effects and cancer response for two years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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17 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Jan 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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. EXCLUSION CRITERIA: * 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 * Inflammatory bowel disease * Active Lupus or Active scleroderma * Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion) * Prior prostatectomy * Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results. * Subjects with severe claustrophobia that is unresponsive to oral anxiolytics * Other medical conditions deemed by the Principal Investigator (or associates) to make the subject unsafe or ineligible for protocol procedures * Subjects weighing \> 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry * 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 * Patients with positive Human Immunodeficiency Virus (HIV) status and currently requiring treatment with agents known to sensitize to irradiation, such as protease inhibitors.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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