NCT07077239 · Jonsson Comprehensive Cancer Center
Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity
(MASAMUNE)
What this study is about
Single-treatment group$1, forward-looking 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.
View original scientific description
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.
Primary outcome measures
Genitourinary Domain Score
Time frame: 5 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations