New radiation approach aims to safely target returning prostate cancer
NCT ID NCT01923506
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This early-stage study tests a high-precision radiation treatment called stereotactic body radiation therapy (SBRT) for men whose prostate cancer has returned after surgery. The main goal is to find the safest dose by monitoring side effects in 26 participants. The treatment delivers focused X-rays directly to the tumor area to reduce damage to healthy tissue.
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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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26 people
The number who actually took part.
- Started
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Nov 2013
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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19 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * History of diagnosis of prostate cancer after undergoing prostatectomy * No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic * Eastern Cooperative Oncology Group (ECOG) performance scale 0-2 * Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable * Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry * PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion * All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patients should not have any uncontrolled illness including ongoing or active infection * Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy * Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years * Study-specific exclusions: * History of prior radiation to the pelvis * History of uncontrolled inflammatory bowel disease * Unable to comply with radiation therapy procedures * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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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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City of Hope Medical Center
Duarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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