Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (CRPC). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Detailed description
This project is a single-arm, prospective 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. There is no pre-specified target enrollment for patients undergoing standard non-adaptive SBRT. The target enrollment of patients undergoing adaptive treatment is 200 patients. The rate of accrual is expected to be in the range of 40 patients per year.
Primary outcome measures
- Genitourinary Domain Score [Time frame: 5 years]
Secondary outcome measures (10)
- Gastrointestinal Domain Score [Time frame: 5 years]
- Sexual Domain Score [Time frame: 5 years]
- Change in IPSS Score [Time frame: 5 years]
- Long-Term Patient Reported GU Symptoms [Time frame: 5 years]
- Long-Term Patient-Reported GI Symptoms [Time frame: 5 years]
- GU and GI Adverse Events [Time frame: 5 years]
- Five-year Cumulative Incidence of GU and GI Adverse Events [Time frame: 5 years]
- Progression-Free Survival [Time frame: 5 years]
- Biochemical Recurrence [Time frame: 5 Years]
- Distant Metastasis-Free Survival [Time frame: 5 years]
Eligibility 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:
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California at Los Angeles — Los Angeles
Identifiers
NCT: NCT07077239 · 25-0627 · NCI-2025-05089