What this study is
Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.
Study details
- 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)
- Sponsor
- Jonsson Comprehensive Cancer Center
- Conditions
- Prostate Cancer (CRPC)
- Enrolling
- 200 people
- Starts
- 2025-07-17
- Est. completion
- 2036-08-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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. ~. KPS ≥ 70 and/or ECOG <2.
- Ability to understand, and willingness to sign, the written informed consent
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California at Los Angeles
Los Angeles, California, United States
- CHRISTY PALODICHUK · Contact310-794-2971cpalodichuk@mednet.ucla.edu
- Luca Valle, MD · Principal investigator
Recruiting
Study team
Sponsor
Jonsson Comprehensive Cancer Center
Study ID 25-0627
Principal investigator
Luca Valle, MD
University of California at Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.