Post-prostatectomy SBRT with MRI/CT adaptive guidance to reduce urinary and bowel side effects
Official title: MAgnetic Resonance Imaging or Computed Tomography Guided Stereotactic Body Radiotherapy With Online Adaptive Technology for Minimizing Toxicity During Salvage or AdjUvaNt Radiotherapy for ProstatE Cancer (MASAMUNE)
Run by Jonsson Comprehensive Cancer Center · NCT07077239 · Data updated 2026-11-12
This registry will try MRI- or CT-guided stereotactic body radiotherapy (SBRT), sometimes using on-table adaptive planning, for men after prostatectomy who have adverse pathology or a rising PSA.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | July 17, 2025 |
| Main results expected | August 1, 2035 |
| Study ends | August 1, 2036 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07077239 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men who have had radical prostatectomy and now have adverse pathologic features, rising PSA, an intermediate/high Decipher score, or nodal involvement and who can undergo pelvic imaging and attend UCLA for treatment.
✕Probably not a fit
Men with widespread metastatic disease, those unable to access SBRT at the study site, or those with very low-risk post-operative findings are unlikely to receive benefit from this registry approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm, prospective registry follows men treated with MRI- or CT-guided SBRT to the prostate bed with or without pelvic lymph node coverage, with adaptive treatments offered at clinician discretion. The study tracks patient-reported urinary and gastrointestinal quality of life up to 24 months after treatment. The target enrollment for patients receiving adaptive treatment is 200, with an expected accrual rate of about 40 patients per year, while there is no preset target for non-adaptive SBRT patients. Pelvic CT and MRI within 120 days are required for enrollment, though MRI exemptions are permitted for contraindications.
Why it matters
Potential benefit: If successful, this approach could reduce urinary and bowel side effects after postoperative radiotherapy while maintaining cancer control.
How similar studies have gone: Early reports of MRI-guided and adaptive SBRT in prostate and pelvic settings have shown promising reductions in toxicity, but prospective postoperative registry data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: 1. 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) 2. Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL 3. Intermediate- or high-risk Decipher genomic classifier score 4. 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. \~. KPS ≥ 70 and/or 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
Where it's running
-
University of California at Los Angeles
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Luca Valle, MD — University of California at Los Angeles
- Study coordinator: Christy Palodichuk
- Email: cpalodichuk@mednet.ucla.edu
- Phone: +1 310-794-2971
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Tinengotinib with a novel endocrine therapy for metastatic castration-resistant prostate cancer
This study tests whether tinengotinib plus an ARPI (darolutamide or enzalutamide) is safe and helps people whose metastatic castration-resistant prostate cancer has progressed on prior ARPI therapy.
-
Treatment for advanced prostate cancer using Pluvicto
This study is testing if a new treatment called Pluvicto can help men with advanced prostate cancer that has spread to their bones feel better and improve their quality of life.
-
Investigating the bioequivalence of triprerelin acetate injections for prostate cancer
This study is testing if two different versions of a prostate cancer injection work the same way for men with the disease who haven't had similar treatments before.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.