Trials Sponsors Conditions Drugs Pricing

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

Outcome Measures

Primary Outcomes (1)

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).
Up to 90 days post-treatment

Secondary Outcomes (10)

Incidence of all grades and grade ≥ 2 toxicities at least possibly related to study therapy
Up to 90 days post-treatment
Change in urinary, bowel, and sexual function
Baseline to 12 months post-treatment

Study Arms (1)

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.

Procedure: Biopsy ProcedureProcedure: Computed TomographyOther: Electronic Health Record ReviewProcedure: Magnetic Resonance ImagingRadiation: MRI-guided Stereotactic Body Radiation TherapyOther: Questionnaire Administration

Interventions

Biopsy ProcedureProcedure

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (MR-guided SBRT)

Computed TomographyProcedure

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Eligibility Criteria

Age18 Years+

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsMale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Documented informed consent of the participant and/or Legally Authorized Representative

Sponsors & Collaborators

City of Hope Medical Center
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (1)

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Julius WengCONTACTjulweng@coh.org

Julius WengPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BiopsyMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis

Study Officials

Julius Weng
City of Hope Medical Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 17, 2026

Study Start

January 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

March 9, 2029

Estimated

You may not qualify if:

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
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
+2 more criteria

Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Prostate Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Treatment (MR-guided SBRT)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Treatment (MR-guided SBRT)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations