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

NCT07769372 | Not Yet Recruiting DMC FDA Device

• 3 other identifiers: 260009NCI-2026-05689P30CA033572
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

• Change in prostate symptoms

  Baseline to 12 months post-treatment

• Change in sexual health

  Baseline to 12 months post-treatment

• Rate of biochemical recurrence

  Up to 5 years

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 Procedure; Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging; Radiation: MRI-guided Stereotactic Body Radiation Therapy; Other: Questionnaire Administration

Interventions

Biopsy Procedure PROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (MR-guided SBRT)

Computed Tomography PROCEDURE

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

Treatment (MR-guided SBRT)

Electronic Health Record Review OTHER

Ancillary studies

Treatment (MR-guided SBRT)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (MR-guided SBRT)

MRI-guided Stereotactic Body Radiation Therapy RADIATION

Undergo MR-guided SBRT

Also known as: Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRT

Treatment (MR-guided SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (MR-guided SBRT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

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 (Estimated): January 1, 2027
• Primary Completion (Estimated): March 9, 2029
• Study Completion (Estimated): March 9, 2029
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

US (1)