Precision radiation may tame rising PSA after prostate surgery
NCT ID NCT04915508
First seen Jul 17, 2026 ยท Last updated Jul 17, 2026
Summary
This phase II trial tests a highly precise, short-course radiation therapy (SBRT) combined with hormone therapy for men whose PSA levels rise after prostate cancer surgery. The goal is to control the cancer while reducing side effects by delivering higher radiation doses in fewer sessions. The study measures quality of life and symptom changes in participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic Body Radiation Therapy (SBRT) and hormone therapy
- What this could lead to
- If successful, this approach could offer a shorter, more precise radiation course with fewer side effects for men with rising PSA after prostatectomy.
- What could go wrong
- This is a mid-stage trial, so the approach may not prove effective or safe for all patients. Side effects from radiation and hormone therapy are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
165 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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Dec 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 any ONE of the following: * Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease) * Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL * Intermediate- or high-risk Decipher genomic classifier score * Identification of prostate cancer in \>= 1 lymph node at the time of prostatectomy (pN+ disease) * CT scan and MRI of the pelvis within 120 days prior to enrollment \[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \< 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\] * Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \> 1.0 ng/mL * Age \>= 18 * Karnofsky performance status (KPS) \>= 70 and/or Eastern Cooperative Oncology Group (ECOG) =\< 2 * Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: * Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator * Patients with neuroendocrine or small cell carcinoma 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
-
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered immune cells take down advanced prostate cancer?
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can MRI-Guided radiation zero in on prostate tumors with fewer side effects?
- Can 3D imaging make prostate radiation more precise and worth the cost?
- Can surgery boost control of spread prostate cancer?
- Can a better scan sharpen radiation for prostate cancer?