Targeted radiation after prostate surgery shows promise in cancer control
NCT ID NCT03541850
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a special type of radiation called stereotactic body radiotherapy (SBRT) can help prevent prostate cancer from coming back after surgery. About 92 men who had their prostate removed and have signs of remaining cancer will receive SBRT. The goal is to see if this treatment can keep PSA levels low and manage side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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92 people
The number who actually took part.
- Started
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Jan 2019
- Expected to finish
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Nov 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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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: * History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent * Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL * Computed tomography (CT) scan and MRI of the pelvis within 120 days prior to enrollment (note: \[a\] if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed \[b\] for patients with PSA \< 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan) * Bone scan within 120 days prior to enrollment; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis, and advanced imaging (e.g., 18NaF positron emission tomography \[PET\]/CT) is strongly recommended * Karnofsky performance score (KPS) \>= 70 * Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: * Patients with any evidence of distant metastases * Patients with pathologically-confirmed N1 prostate cancer * Patients with neuroendocrine or small cell carcinoma of the prostate * Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate * Prior pelvic radiotherapy * History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
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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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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
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USC Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New hope for hard-to-treat prostate cancer: adding immunotherapy to current drug