NCT03541850Active, not recruitingPhase 2
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy
Source: ClinicalTrials.gov · Last updated 6 Nov 2025
Brief summary (registry, in English)
This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- First submitted
- 9 Apr 2018
- Start date
- 29 Jan 2019
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT03541850
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 92
- From 29 Jan 2019 to the primary completion date, 1 Nov 2026
- 2 sites 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
- Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate
- Prior pelvic radiotherapy
Other illness
- Patients with pathologically-confirmed N1 prostate cancer
- History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
Other
- Patients with any evidence of distant metastases
- Patients with neuroendocrine or small cell carcinoma of the prostate
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| USC Norris Comprehensive Cancer Center and Hospital Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.