Stage I Prostate Cancer AJCC v8NCT07769372
Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Prostate Cancer
A study testing Biopsy Procedure, Computed Tomography and Electronic Health Record Review in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial studies the side effects and how well magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8
- What is being tested?
- Biopsy Procedure, Computed Tomography and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 9 Mar 2029
- 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
- Documented informed consent of the participant and/or Legally Authorized Representative
- Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- National Comprehensive Cancer Network (NCCN) low-risk or intermediate-risk prostate cancer, defined as:
- Low-risk: Prostate-specific antigen (PSA) < 10 ng/mL AND grade group 1 (Gleason score 3+3) AND clinical stage T1-T2a
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- Intermediate-risk (one or more of the following intermediate risk factors [IRFs]): PSA 10-20 ng/mL, grade group 2 or 3 (Gleason 3+4 or 4+3), or clinical stage T2b-T2c
- Favorable intermediate-risk (all of the following): 1 IRF, grade group 1 or 2, < 50% cores positive
- Unfavorable intermediate-risk (one or more of the following): 2 or 3 IRFs, grade group 3, ≥ 50% cores positive
- Biopsies from a single region of interest (ROI) are counted as a single sample
- Diagnostic multiparametric MRI (mpMRI) of the prostate (within 6 months prior to enrollment) with MRI-visible dominant lesion defined as Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 3
- Prostate biopsy, including targeted and systematic biopsy. All PI-RADS ≥ 3 lesions must be sampled by MRI-targeted biopsy. Biopsy results must confirm concordance between the MRI-visible lesion and histologically confirmed prostate adenocarcinoma. Patients with any positive biopsy core (any grade group) from a region not attributable to the MRI-defined PI-RADS ≥ 3 lesion(s) are excluded
- Unilateral disease, defined as: the MRI-visible dominant lesion(s) and all biopsy-confirmed prostate cancer confined to one prostatic lobe. Multiple lesions are permitted provided they can be encompassed within a single focal treatment planning volume
- Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Who cannot join
- Chemotherapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy
- Current or planned androgen deprivation therapy (ADT), including leutenizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, antiandrogens, or prior bilateral orchiectomy. Prior 5-alpha reductase inhibitor use is permitted if discontinued ≥ 90 days prior to baseline PSA assessment or if the corrected PSA value (measured PSA × 2) meets protocol risk group eligibility criteria (≤ 20 ng/mL)
- Prior focal therapy for prostate cancer, including but not limited to high intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation (IRE), laser ablation, or photodynamic therapy
- Prior pelvic radiation therapy
- Prior prostate procedures for BPH (including but not limited to transurethral resection of the prostate [TURP], UroLift, Aquablation, Rezūm, prostate artery embolization) that, in the opinion of the treating radiation oncologist, have significantly altered prostatic anatomy such that focal SBRT treatment planning would be compromised or leads to increased risk of treatment-related toxicity
- For patients with severe baseline lower urinary tract symptoms (International Prognostic Scoring System [IPSS] ≥ 20), the treating radiation oncologist should confirm that the patient's baseline urinary function and location/volume of target does not, in their clinical judgment, represent an unacceptable risk for treatment-related urinary morbidity
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- Clinically significant uncontrolled illness. Patients that are known to be HIV-infected that are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Patient has baseline grade ≥ 3 gastrointestinal (GI) or genitourinary (GU) toxicity
- History of prior rectal surgery (e.g., low anterior resection, abdominoperineal resection) or other pelvic surgery that, in the opinion of the treating radiation oncologist, would significantly alter normal pelvic anatomy and compromise safe treatment delivery
- Active inflammatory bowel disease (ulcerative colitis or Crohn's disease) involving the rectum or sigmoid colon
- Contraindication to magnetic resonance imaging, including but not limited to:
- Implanted metallic devices not certified as MRI-conditional (e.g., non-MRI-conditional cardiac pacemakers, defibrillators, neurostimulators, cochlear implants, metallic foreign bodies)
- Severe claustrophobia not manageable with anxiolytic medication and/or supportive measures
- Inability to tolerate supine positioning for the duration of MR-guided treatment delivery (approximately 30-45 minutes per fraction)
- Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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
City of Hope at Irvine Lennar
Irvine, California, 92618
Julius Weng, julweng@coh.org
Julius Weng
About this study
Official title: A Pilot Study of Focal Magnetic Resonance (MR)-Guided Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
This clinical trial studies the side effects and how well magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. MR-guided SBRT uses magnetic resonance imaging (MRI) to define and localize the area to be treated, which may help provide more accurate delivery of SBRT and lower side effects. MR-guided SBRT may be safe, tolerable, and/or effective in treating patients with prostate cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the safety of performing focal MR-guided SBRT.
SECONDARY OBJECTIVES:
- To assess the tolerability of focal MR-guided SBRT. II. To characterize changes in urinary, bowel and sexual function in patients receiving focal MR-guided SBRT.
III. To characterize changes in prostate symptoms in patients receiving focal MR-guided SBRT.
IV. To characterize changes in sexual health in patients receiving focal MR-guided SBRT.
- To estimate the rate of biochemical recurrence after receiving focal MR-guided SBRT.
VI. To estimate the rate of in-field prostate recurrence after receiving focal MR-guided SBRT.
VII. To estimate the rate of out-of-field prostate recurrence after receiving focal MR-guided SBRT.
VIII. To estimate the rate of salvage therapy after receiving focal MR-guided SBRT.
IX. To estimate the time to local radiographic progression after receiving focal MR-guided SBRT.
- To estimate the time to distant radiographic progression after receiving focal MR-guided SBRT.
EXPLORATORY OBJECTIVES:
- To characterize changes in imaging features from pre-treatment to post-treatment, assessed using multiparametric prostate MRI (including T2 weighted imaging, apparent diffusion coefficient (ADC) values, and dynamic contrast-enhanced (DCE) perfusion metrics, as well as radiomic features, and prostate-specific membrane antigen positron emission tomography (PSMA PET) imaging, if available.
II. To characterize the intraprostatic tumor microenvironment and clonal dynamics following focal SBRT using surveillance biopsy tissue obtained at 2 years post-treatment, with comparison of cores sampled within versus outside the radiation field.
OUTLINE:
Patients undergo five treatment fractions of MR-guided SBRT over 30-45 minutes each up to three times a week (TIW) over approximately 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and biopsy throughout the study as well as computed tomography (CT) on study.
After completion of study treatment, patients are followed up at 90 days, 12 months, and then every 6 months for 4 years.
- Conditions
- Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- Being tested
- Biopsy Procedure, Computed Tomography, Electronic Health Record Review, Magnetic Resonance Imaging, MRI-guided Stereotactic Body Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Electronic Health Record ReviewOther
Ancillary studies
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 MR-guided SBRT
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (MR-guided SBRT) | Experimental | Patients undergo five treatment fractions of MR-guided SBRT over 30-45 minutes each up to TIW over approximately 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and biopsy throughout the study as well as CT on study. Receives: Procedure: Biopsy Procedure; Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging; Radiation: MRI-guided Stereotactic Body Radiation Therapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥ 3 treatment-related toxicity
Safety defined as patients completing focal magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) without grade ≥ 3 treatment-related toxicity (per Common Terminology Criteria for Adverse Events [CTCAE] version [v] 6.0) occurring within 90 days post treatment. Will be estimated along with its associated 95% Clopper Pearson exact binomial confidence interval (CI).
Measured: Up to 90 days post-treatment
Secondary outcomes (10)
Incidence of all grades and grade ≥ 2 toxicities at least possibly related to study therapy
Tolerability of focal MR-Guided SBRT, defined as rate of all-grades and grade ≥ 2 toxicities at least possibly related to study therapy as measured by CTCAE v6.0. Will be summarized descriptively. Toxicities will be further categorized by timing (acute: ≤ 90 days post SBRT; late: 91 days to 1 year post SBRT) and by organ system, specifically genitourinary and gastrointestinal.
Measured: Up to 90 days post-treatment
Change in urinary, bowel, and sexual function
Measured using the Expanded Prostate Cancer Index Composite-26 questionnaire. Will be summarized descriptively at each scheduled assessment time point among participants with available data.
Measured: Baseline to 12 months post-treatment
Change in prostate symptoms
Measured using the International Prostate Symptom Score questionnaire. Will be summarized descriptively at each scheduled assessment time point among participants with available data.
Measured: Baseline to 12 months post-treatment
Change in sexual health
Measured using the Sexual Health Inventory for Men. Will be summarized descriptively at each scheduled assessment time point among participants with available data.
Measured: Baseline to 12 months post-treatment
Rate of biochemical recurrence
Defined as the proportion of patients experiencing an increase in prostate-specific antigen ≥ 2ng/mL above post-SBRT nadir. Will be summarized descriptively in the efficacy population, using proportions with corresponding CIs, consistent with the methods used for the primary endpoint.
Measured: Up to 5 years
Rate of prostate in-field recurrence
Defined as the proportion of patients experiencing persistent or recurrent biopsy proven cancer in the treatment field. Will be summarized descriptively in the efficacy population, using proportions with corresponding CIs, consistent with the methods used for the primary endpoint.
Measured: Up to 5 years
Rate of prostate out-of-field recurrence
Defined as the proportion of patients experiencing persistent or recurrent biopsy proven cancer in the prostate out-of-field. Will be summarized descriptively in the efficacy population, using proportions with corresponding CIs, consistent with the methods used for the primary endpoint.
Measured: Up to 5 years
Rate of salvage therapy
Defined as the proportion of patients receiving salvage therapy (prostatectomy, additional radiation therapy, androgen deprivation therapy) after SBRT. Will be summarized descriptively in the efficacy population, using proportions with corresponding CIs, consistent with the methods used for the primary endpoint.
Measured: Up to 5 years
Time to local radiographic progression
Will be estimated using Kaplan-Meier methods, along with their corresponding 95% CIs using log log transformation with Greenwood's estimator of variance. Death without prior progression will be treated as a competing risk, and cumulative incidence functions will be estimated accordingly.
Measured: From initiation of SBRT to the first local radiographic progression in treatment field and remaining prostate, assessed up to 5 years
Time to distant radiographic progression
Will be estimated using Kaplan-Meier methods, along with their corresponding 95% CIs using log log transformation with Greenwood's estimator of variance. Death without prior progression will be treated as a competing risk, and cumulative incidence functions will be estimated accordingly.
Measured: From initiation of SBRT to the first distant/metastatic radiographic progression, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion9 Mar 2029 (estimated)
- Study completion9 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Prostate Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julius Weng, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769372
- Sponsor's protocol ID
- 260009
- Other IDs
- NCI-2026-05689, 260009, P30CA033572
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Focal Magnetic Resonance (MR)-Guided Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
- ClinicalTrials.gov ID
- NCT07769372
- Acronym / sponsor ID
- 260009
- Conditions
- Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 9 Mar 2029 (estimated)
- Study completion
- 9 Mar 2029 (estimated)
- First posted
- 17 Aug 2026 (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 and how well magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. MR-guided SBRT uses magnetic resonance imaging (MRI) to define and localize the area to be treated, which may help provide more accurate delivery of SBRT and lower side effects. MR-guided SBRT may be safe, tolerable, and/or effective in treating patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVE:
- To determine the safety of performing focal MR-guided SBRT.
SECONDARY OBJECTIVES:
- To assess the tolerability of focal MR-guided SBRT. II. To characterize changes in urinary, bowel and sexual function in patients receiving focal MR-guided SBRT.
III. To characterize changes in prostate symptoms in patients receiving focal MR-guided SBRT.
IV. To characterize changes in sexual health in patients receiving focal MR-guided SBRT.
- To estimate the rate of biochemical recurrence after receiving focal MR-guided SBRT.
VI. To estimate the rate of in-field prostate recurrence after receiving focal MR-guided SBRT.
VII. To estimate the rate of out-of-field prostate recurrence after receiving focal MR-guided SBRT.
VIII. To estimate the rate of salvage therapy after receiving focal MR-guided SBRT.
IX. To estimate the time to local radiographic progression after receiving focal MR-guided SBRT.
- To estimate the time to distant radiographic progression after receiving focal MR-guided SBRT.
EXPLORATORY OBJECTIVES:
- To characterize changes in imaging features from pre-treatment to post-treatment, assessed using multiparametric prostate MRI (including T2 weighted imaging, apparent diffusion coefficient (ADC) values, and dynamic contrast-enhanced (DCE) perfusion metrics, as well as radiomic features, and prostate-specific membrane antigen positron emission tomography (PSMA PET) imaging, if available.
II. To characterize the intraprostatic tumor microenvironment and clonal dynamics following focal SBRT using surveillance biopsy tissue obtained at 2 years post-treatment, with comparison of cores sampled within versus outside the radiation field.
OUTLINE:
Patients undergo five treatment fractions of MR-guided SBRT over 30-45 minutes each up to three times a week (TIW) over approximately 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and biopsy throughout the study as well as computed tomography (CT) on study.
After completion of study treatment, patients are followed up at 90 days, 12 months, and then every 6 months for 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (MR-guided SBRT) | Experimental | Procedure: Biopsy Procedure, Procedure: Computed Tomography, Other: Electronic Health Record Review, Procedure: Magnetic Resonance Imaging, Radiation: MRI-guided Stereotactic Body Radiation Therapy, Other: Questionnaire AdministrationPatients undergo five treatment fractions of MR-guided SBRT over 30-45 minutes each up to TIW over approximately 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and biopsy throughout the study as well as CT on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Documented informed consent of the participant and/or Legally Authorized Representative
- Age: ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- National Comprehensive Cancer Network (NCCN) low-risk or intermediate-risk prostate cancer, defined as:
- Diagnostic multiparametric MRI (mpMRI) of the prostate (within 6 months prior to enrollment) with MRI-visible dominant lesion defined as Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 3
Key exclusion criteria (17 listed)
- Chemotherapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy
- Current or planned androgen deprivation therapy (ADT), including leutenizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, antiandrogens, or prior bilateral orchiectomy. Prior 5-alpha reductase inhibitor use is permitted if discontinued ≥ 90 days prior to baseline PSA assessment or if the corrected PSA value (measured PSA × 2) meets protocol risk group eligibility criteria (≤ 20 ng/mL)
- Prior focal therapy for prostate cancer, including but not limited to high intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation (IRE), laser ablation, or photodynamic therapy
- Prior pelvic radiation therapy
- Prior prostate procedures for BPH (including but not limited to transurethral resection of the prostate [TURP], UroLift, Aquablation, Rezūm, prostate artery embolization) that, in the opinion of the treating radiation oncologist, have significantly altered prostatic anatomy such that focal SBRT treatment planning would be compromised or leads to increased risk of treatment-related toxicity
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 |
|---|---|---|
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Treatment (MR-guided SBRT) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (MR-guided SBRT) |
| Electronic Health Record ReviewAncillary studies | Other | Treatment (MR-guided SBRT) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (MR-guided SBRT) |
| MRI-guided Stereotactic Body Radiation TherapyAlso: Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRTUndergo MR-guided SBRT | Radiation | Treatment (MR-guided SBRT) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (MR-guided SBRT) |
Primary outcome
Incidence of grade ≥ 3 treatment-related toxicity
Time frame: Up to 90 days post-treatment
Safety defined as patients completing focal magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) without grade ≥ 3 treatment-related toxicity (per Common Terminology Criteria for Adverse Events [CTCAE] version [v] 6.0) occurring within 90 days post treatment. Will be estimated along with its associated 95% Clopper Pearson exact binomial confidence interval (CI).
10 secondary outcomes
Incidence of all grades and grade ≥ 2 toxicities at least possibly related to study therapy
Time frame: Up to 90 days post-treatment
Change in urinary, bowel, and sexual function
Time frame: Baseline to 12 months post-treatment
Change in prostate symptoms
Time frame: Baseline to 12 months post-treatment
Change in sexual health
Time frame: Baseline to 12 months post-treatment
Rate of biochemical recurrence
Time frame: Up to 5 years
Rate of prostate in-field recurrence
Time frame: Up to 5 years
Rate of prostate out-of-field recurrence
Time frame: Up to 5 years
Rate of salvage therapy
Time frame: Up to 5 years
Time to local radiographic progression
Time frame: From initiation of SBRT to the first local radiographic progression in treatment field and remaining prostate, assessed up to 5 years
Time to distant radiographic progression
Time frame: From initiation of SBRT to the first distant/metastatic radiographic progression, assessed up to 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 17 Aug 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.
Julius Weng principal investigator
City of Hope Medical 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 Biopsy Procedure, Computed Tomography and Electronic Health Record Review in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by City of Hope Medical 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 15 inclusion and 17 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: opening soon, as of the sponsor's last update on 17 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥ 3 treatment-related toxicity (time frame: Up to 90 days post-treatment). 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 17 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.