Prostate Cancer (CRPC)MASAMUNENCT07077239
Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity
An observational study of Prostate Cancer (CRPC), run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (CRPC)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to 1 Aug 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pN0 or pN1 prostate cancer undergoing postoperative radiotherapy targeting the prostate bed +/- pelvic lymph nodes
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California at Los Angeles
Los Angeles, California, 90095
CHRISTY PALODICHUK, 310-794-2971, cpalodichuk@mednet.ucla.edu
Luca Valle, MD
About this study
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)
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.
Read the 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.
- Conditions
- Prostate Cancer (CRPC)
- Keywords
- prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Guided Stereotactic Body Radiotherapy | Patient who has elected to receive SBRT following prostatectomy: eligibility determination based on PSA, pathology, and/or Decipher score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genitourinary Domain Score
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.
Measured: 5 years
Secondary outcomes (10)
Gastrointestinal Domain Score
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.
Measured: 5 years
Sexual Domain Score
To determine the rate of 2x MCID changes in any sexual 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, with a comparison to historical control data for non-adaptive post-prostatectomy SBRT regimens.
Measured: 5 years
Change in IPSS Score
To quantify changes in IPSS score at 3 month intervals within the first 12 months of treatment, then at 6 month intervals thereafter until 5 years.
Measured: 5 years
Long-Term Patient Reported GU Symptoms
To quantify long-term patient-reported GU symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years.
Measured: 5 years
Long-Term Patient-Reported GI Symptoms
To quantify long-term patient-reported GI symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years.
Measured: 5 years
GU and GI Adverse Events
To quantify rates and severity of acute physician scored GU and GI adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) scale.
Measured: 5 years
Five-year Cumulative Incidence of GU and GI Adverse Events
To quantify the five-year cumulative incidence of physician scored GU and GI adverse events using the CTCAE v5.0 scale.
Measured: 5 years
Progression-Free Survival
quantify five-year progression-free survival.
Measured: 5 years
Biochemical Recurrence
To quantify 5-year cumulative incidence of biochemical recurrence.
Measured: 5 Years
Distant Metastasis-Free Survival
To quantify 5-year distant metastasis-free survival.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start17 Jul 2025
- Primary completion1 Aug 2035 (estimated)
- Study completion1 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (CRPC)Studies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Valle, MD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077239
- Sponsor's protocol ID
- 25-0627
- Other IDs
- NCI-2025-05089
- Acronym
- MASAMUNE
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07077239
- Acronym / sponsor ID
- MASAMUNE / 25-0627
- Conditions
- Prostate Cancer (CRPC)
- Keywords
- prostatectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 1 Aug 2035 (estimated)
- Study completion
- 1 Aug 2036 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Stereotactic Body Radiotherapy | – | –Patient who has elected to receive SBRT following prostatectomy: eligibility determination based on PSA, pathology, and/or Decipher score |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pN0 or pN1 prostate cancer undergoing postoperative radiotherapy targeting the prostate bed +/- pelvic lymph nodes
Key inclusion criteria (11 listed)
- History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent.
- Presence of any ONE of the following:
- 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.
Key exclusion criteria (4 listed)
- 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.
- History of Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer (CRPC)
RecruitingPhase 2
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer
RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
RecruitingObservational study
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
RecruitingPhase 1
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Advanced Prostate Cancer, Metastatic Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Valle, MD principal investigator
University of California at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (CRPC), run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHRISTY PALODICHUK (+1 310-794-2971, cpalodichuk@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genitourinary Domain Score (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.