Localized Prostate AdenocarcinomaNCT07276438
Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Cancer, MANTICORE Trial
A study testing Biospecimen Collection, Computed Tomography and CT-guided Stereotactic Body Radiation Therapy in people with Localized Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and CT-guided Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Dec 2032
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18
- Histologically confirmed, clinically localized adenocarcinoma of the prostate
- Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping
- Advanced imaging studies (i.e. prostate-specific membrane antigen [PSMA] positron emission tomography [PET]/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first
- No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET/CT scan below the bifurcation of the renal arteries are amenable)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- No indication for urgent or emergent radiation
- Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
Who cannot join
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator
- Prior cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate
- Prior pelvic radiotherapy
- History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data
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
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Care Felix, 310-825-9771, cfelix@mednet.ucla.edu
CHRISTY PALODICHUK, +1 310-794-2971, cpalodichuk@mednet.ucla.edu
About this study
Official title: MRI- or CT-Guidance and Online Adaptation With Stereotactic Radiotherapy for Prostate Cancer (MANTICORE)
This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Image-guided SBRT is a standard treatment for localized prostate cancer. This treatment uses imaging of the cancer within the body to define and localize the area to be treated with the radiation. Imaging can be obtained using either computed tomography (CT), magnetic resonance imaging (MRI), or a combination of the two. Typically, with SBRT, a radiation plan is developed based on the CT or MRI images obtained before treatment begins and adjustments are not made to the plan during treatment. However, anatomy can be different from day-to-day which may cause radiation to be delivered to the normal surrounding structures and possibly more side effects. During image-guided SBRT with online adaptation, the initial radiation plan is designed similarly; however, when the patient presents for radiation, the attending radiation oncologist, a dosimetrist, and a medical physicist "re-optimize" the radiation plan using the current anatomy of the day, meaning the changes in bladder and prostate size/shape are taken into account. The initial plan and the re-optimized plan are then compared, and the plan that has the optimal balance between delivering a tumor killing dose of radiation and minimizing radiation dose to normal surrounding structures is delivered. Image-guidance and online adaptation with SBRT may lower side effects and be a safer way to treat localized prostate adenocarcinoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether daily, real-time adaptive SBRT to the prostate improves acute patient-reported genitourinary (GU) toxicity when compared with conventional, non-adaptive SBRT to the prostate for localized prostate cancer.
SECONDARY OBJECTIVES:
- To determine whether there are differences in the acute, patient-reported other toxicity following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
II. To determine whether there are chronic differences in patient-reported quality of life (QOL) outcomes following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
III. To determine whether there are differences in the acute and late physician-scored GU and gastrointestinal (GI) toxicity following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
IV. To determine whether there are differences in the 5-year biochemical recurrence-free survival (BCRFS) following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
CORRELATIVE OBJECTIVE:
- To correlate patient-reported and physician-scored toxicity with a commercially available genetic biomarker (PROSTOX trademark, MiraDx, Los Angeles, CA).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or once daily (QD) for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity.
Additionally, all patients undergo MRI and CT during screening and blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at months 1, 3, 6, 9, 12, 24, 36, 48, and 60.
- Conditions
- Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, CT-guided Stereotactic Body Radiation Therapy, Inter-fraction Adaptation of Treatment Plan, Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
CT-guided Stereotactic Body Radiation TherapyRadiation
Also called Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRT
Undergo CT-guided SBRT
Inter-fraction Adaptation of Treatment PlanOther
Also called Inter-fraction adaptation
Undergo daily plan adaptation
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
MRI-guided Stereotactic Body Radiation TherapyRadiation
Also called Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRT
Undergo MRI-guided SBRT
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (non-adaptive SBRT) | Active comparator | Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: CT-guided Stereotactic Body Radiation Therapy; Procedure: Magnetic Resonance Imaging; Radiation: MRI-guided Stereotactic Body Radiation Therapy; Other: Survey Administration |
| Arm 2 (adaptive SBRT) | Experimental | Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: CT-guided Stereotactic Body Radiation Therapy; Other: Inter-fraction Adaptation of Treatment Plan; Procedure: Magnetic Resonance Imaging; Radiation: MRI-guided Stereotactic Body Radiation Therapy; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26)
A clinically relevant decrement in the EPIC-26 urinary irritative/obstructive domain is defined as greater than 14 points. Will compare the proportion of patients with a clinically relevant in genitourinary EPIC-26 urinary irritative/obstructive subdomain within 90 days of study therapy via a simple binomial test for differences in proportions. A more granular analysis will be based on the cumulative incidence method will be used to summarize risk of clinically relevant decline and Fine-Gray test will be used to compare cumulative incidences between the two arms. The analysis population includes all randomized subjects based on intent-to-treat principle. Point estimates as well as the associated 95% confidence intervals will be reported. Will also be evaluated using a multivariable analysis adjusted for variables including a simultaneous integrated boost, use of nodal radiotherapy, and use of hydrogel spacers.
Measured: From start of stereotactic body radiation therapy (SBRT) to 90 days following SBRT
Secondary outcomes (9)
Acute change in EPIC-26 scores
Will be represented by changes from baseline in the urinary incontinence, bowel, sexual function, and hormone/vitality domains. Changes will be analyzed with respect to whether they represent clinically relevant differences, defined as greater than 18, 12, and 24 points for urinary incontinence, bowel, and sexual domains, respectively. Analysis will be performed using a restricted maximum likelihood (REML)-based mixed models repeated measures (MMRM) approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom. The analysis of acute changes in the bowel domain of the EPIC-26 instrument will be stratified for use of hydrogel spacers or not.
Measured: From start of SBRT to 90 days following SBRT
Acute change in International Prostate Symptom Score (IPSS)
The numerical change from baseline, as well as the raw score at any given timepoint, will be extracted and reported descriptively; an absolute change of ≥ 15 points on IPSS will be considered a clinically relevant change. Analysis will be performed using a REML-based MMRM approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.
Measured: From start of SBRT to 90 days following SBRT
Acute change in Sexual Health Inventory for Men (SHIM) scores
The numerical change from baseline, as well as the raw score at any given timepoint, will be extracted and reported descriptively; an absolute change of ≥ 10 points on the SHIM will be considered a clinically relevant change. Analysis will be performed using a REML-based MMRM approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.
Measured: From start of SBRT to 90 days following SBRT
Chronic change in EPIC-26 scores
Will be represented by changes from baseline in the urinary incontinence, bowel, sexual function, and hormone/vitality domains. Changes will be analyzed with respect to whether they represent clinically relevant differences, defined as greater than 18, 12, and 24 points for urinary incontinence, bowel, and sexual domains, respectively. Analysis will be performed using a REML-based MMRM approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom. The analysis of chronic changes in the bowel domain of the EPIC-26 instrument will be stratified for use of hydrogel spacers or not.
Measured: From start of SBRT to 60 months following SBRT
Chronic change in IPSS
The numerical change from baseline, as well as the raw score at any given timepoint, will be extracted and reported descriptively; an absolute change of ≥ 15 points on IPSS will be considered a clinically relevant change. Analysis will be performed using a REML-based MMRM approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.
Measured: From start of SBRT to 60 months following SBRT
Chronic change in SHIM scores
The numerical change from baseline, as well as the raw score at any given timepoint, will be extracted and reported descriptively; an absolute change of ≥ 10 points on the SHIM will be considered a clinically relevant change. Analysis will be performed using a REML-based MMRM approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.
Measured: From start of SBRT to 60 months following SBRT
Incidence of physician-scored acute grade ≥ 2 genitourinary (GU) and gastrointestinal (GI) toxicities
As assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 scale. The analysis of both acute and late GI toxicity will be stratified for use of hydrogel spacers or not and by use of nodal radiotherapy or not, if event rate permits this analysis.
Measured: From start of SBRT to 90 days following SBRT
Incidence of physician-score late grade ≥ 2 GU and GI toxicities
As assessed using CTCAE v 5.0 scale. The analysis of both acute and late GI toxicity will be stratified for use of hydrogel spacers or not and by use of nodal radiotherapy or not, if event rate permits this analysis.
Measured: From start of SBRT to 60 months following SBRT
Biochemical recurrence-free survival
Will be estimated by the Kaplan-Meier method as well as descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum), with biochemical recurrence defined as serum prostate-specific antigen (PSA) levels that are 2 ng/mL higher than the nadir PSA achieved after SBRT. Figures showing the Kaplan-Meier estimates will also be presented. Death of any cause will be treated as a competing risk.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate AdenocarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Viewray Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amar W. Kishan, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276438
- Sponsor's protocol ID
- 24-000781
- Other IDs
- NCI-2025-07701, 24-000781, P30CA016042, R37CA292795
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI- or CT-Guidance and Online Adaptation With Stereotactic Radiotherapy for Prostate Cancer (MANTICORE)
- ClinicalTrials.gov ID
- NCT07276438
- Acronym / sponsor ID
- 24-000781
- Conditions
- Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Viewray Inc., National Cancer Institute (NCI)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 11 Dec 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.
This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Image-guided SBRT is a standard treatment for localized prostate cancer. This treatment uses imaging of the cancer within the body to define and localize the area to be treated with the radiation. Imaging can be obtained using either computed tomography (CT), magnetic resonance imaging (MRI), or a combination of the two. Typically, with SBRT, a radiation plan is developed based on the CT or MRI images obtained before treatment begins and adjustments are not made to the plan during treatment. However, anatomy can be different from day-to-day which may cause radiation to be delivered to the normal surrounding structures and possibly more side effects. During image-guided SBRT with online adaptation, the initial radiation plan is designed similarly; however, when the patient presents for radiation, the attending radiation oncologist, a dosimetrist, and a medical physicist "re-optimize" the radiation plan using the current anatomy of the day, meaning the changes in bladder and prostate size/shape are taken into account. The initial plan and the re-optimized plan are then compared, and the plan that has the optimal balance between delivering a tumor killing dose of radiation and minimizing radiation dose to normal surrounding structures is delivered. Image-guidance and online adaptation with SBRT may lower side effects and be a safer way to treat localized prostate adenocarcinoma.
Detailed description
PRIMARY OBJECTIVE:
- To determine whether daily, real-time adaptive SBRT to the prostate improves acute patient-reported genitourinary (GU) toxicity when compared with conventional, non-adaptive SBRT to the prostate for localized prostate cancer.
SECONDARY OBJECTIVES:
- To determine whether there are differences in the acute, patient-reported other toxicity following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
II. To determine whether there are chronic differences in patient-reported quality of life (QOL) outcomes following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
III. To determine whether there are differences in the acute and late physician-scored GU and gastrointestinal (GI) toxicity following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
IV. To determine whether there are differences in the 5-year biochemical recurrence-free survival (BCRFS) following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
CORRELATIVE OBJECTIVE:
- To correlate patient-reported and physician-scored toxicity with a commercially available genetic biomarker (PROSTOX trademark, MiraDx, Los Angeles, CA).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or once daily (QD) for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity.
Additionally, all patients undergo MRI and CT during screening and blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at months 1, 3, 6, 9, 12, 24, 36, 48, and 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (non-adaptive SBRT) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Radiation: CT-guided Stereotactic Body Radiation Therapy, Procedure: Magnetic Resonance Imaging, Radiation: MRI-guided Stereotactic Body Radiation Therapy, Other: Survey AdministrationPatients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial. |
| Arm 2 (adaptive SBRT) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Radiation: CT-guided Stereotactic Body Radiation Therapy, Other: Inter-fraction Adaptation of Treatment Plan, Procedure: Magnetic Resonance Imaging, Radiation: MRI-guided Stereotactic Body Radiation Therapy, Other: Survey AdministrationPatients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18
- Histologically confirmed, clinically localized adenocarcinoma of the prostate
- Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping
- No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET/CT scan below the bifurcation of the renal arteries are amenable)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (6 listed)
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator
- Prior cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate
- Prior pelvic radiotherapy
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm 1 (non-adaptive SBRT), Arm 2 (adaptive SBRT) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm 1 (non-adaptive SBRT), Arm 2 (adaptive SBRT) |
| CT-guided Stereotactic Body Radiation TherapyAlso: Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRTUndergo CT-guided SBRT | Radiation | Arm 1 (non-adaptive SBRT), Arm 2 (adaptive SBRT) |
| Inter-fraction Adaptation of Treatment PlanAlso: Inter-fraction adaptationUndergo daily plan adaptation | Other | Arm 2 (adaptive SBRT) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Arm 1 (non-adaptive SBRT), Arm 2 (adaptive SBRT) |
| MRI-guided Stereotactic Body Radiation TherapyAlso: Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRTUndergo MRI-guided SBRT | Radiation | Arm 1 (non-adaptive SBRT), Arm 2 (adaptive SBRT) |
| Survey AdministrationAncillary studies | Other | Arm 1 (non-adaptive SBRT), Arm 2 (adaptive SBRT) |
Primary outcome
Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26)
Time frame: From start of stereotactic body radiation therapy (SBRT) to 90 days following SBRT
A clinically relevant decrement in the EPIC-26 urinary irritative/obstructive domain is defined as greater than 14 points. Will compare the proportion of patients with a clinically relevant in genitourinary EPIC-26 urinary irritative/obstructive subdomain within 90 days of study therapy via a simple binomial test for differences in proportions. A more granular analysis will be based on the cumulative incidence method will be used to summarize risk of clinically relevant decline and Fine-Gray test will be used to compare cumulative incidences between the two arms. The analysis population includes all randomized subjects based on intent-to-treat principle. Point estimates as well as the associated 95% confidence intervals will be reported. Will also be evaluated using a multivariable analysis adjusted for variables including a simultaneous integrated boost, use of nodal radiotherapy, and use of hydrogel spacers.
9 secondary outcomes
Acute change in EPIC-26 scores
Time frame: From start of SBRT to 90 days following SBRT
Acute change in International Prostate Symptom Score (IPSS)
Time frame: From start of SBRT to 90 days following SBRT
Acute change in Sexual Health Inventory for Men (SHIM) scores
Time frame: From start of SBRT to 90 days following SBRT
Chronic change in EPIC-26 scores
Time frame: From start of SBRT to 60 months following SBRT
Chronic change in IPSS
Time frame: From start of SBRT to 60 months following SBRT
Chronic change in SHIM scores
Time frame: From start of SBRT to 60 months following SBRT
Incidence of physician-scored acute grade ≥ 2 genitourinary (GU) and gastrointestinal (GI) toxicities
Time frame: From start of SBRT to 90 days following SBRT
Incidence of physician-score late grade ≥ 2 GU and GI toxicities
Time frame: From start of SBRT to 60 months following SBRT
Biochemical recurrence-free survival
Time frame: Up to 60 months
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 5 Feb 2026.
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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.
Amar W. Kishan, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Computed Tomography and CT-guided Stereotactic Body Radiation Therapy in people with Localized Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, 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 8 inclusion and 6 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 5 Feb 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 Carol W. Felix (310-825-9771, cfelix@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26) (time frame: From start of stereotactic body radiation therapy (SBRT) to 90 days following SBRT). 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 5 Feb 2026.