Clinical trial · Observational
Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (CRPC) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Guided Stereotactic Body Radiotherapy
- description
- Patient who has elected to receive SBRT following prostatectomy: eligibility determination based on PSA, pathology, and/or Decipher score
Primary outcomes (1)
- measure
- Genitourinary Domain Score
- timeFrame
- 5 years
- description
- To determine the rate of 2x MCID changes in any genitourinary domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes.
Secondary outcomes (10)
- measure
- Gastrointestinal Domain Score
- timeFrame
- 5 years
- description
- To determine the rate of 2x MCID changes in any gastrointestinal domain score of the patient-reported EPIC-26 QOL tool at any point between baseline and 24 months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for non-adaptive post-prostatectomy SBRT regimens.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available