Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Cancer, MANTICORE Trial

NCT07276438 | Recruiting DMC FDA Device

• 4 other identifiers: 24-000781NCI-2025-07701P30CA016042R37CA292795
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Localized Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of stereotactic body radiation therapy (SBRT) to 90 days following SBRT

Secondary Outcomes (9)

• Acute change in EPIC-26 scores

  From start of SBRT to 90 days following SBRT

• Acute change in International Prostate Symptom Score (IPSS)

  From start of SBRT to 90 days following SBRT

• Acute change in Sexual Health Inventory for Men (SHIM) scores

  From start of SBRT to 90 days following SBRT

• Chronic change in EPIC-26 scores

  From start of SBRT to 60 months following SBRT

• Chronic change in IPSS

  From start of SBRT to 60 months following SBRT

Study Arms (2)

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.

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.

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

Interventions

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

Arm 1 (non-adaptive SBRT); Arm 2 (adaptive SBRT)

CT-guided Stereotactic Body Radiation Therapy RADIATION

Undergo CT-guided SBRT

Also known as: Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRT

Arm 1 (non-adaptive SBRT); Arm 2 (adaptive SBRT)

Inter-fraction Adaptation of Treatment Plan OTHER

Undergo daily plan adaptation

Also known as: Inter-fraction adaptation

Arm 2 (adaptive 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

Arm 1 (non-adaptive SBRT); Arm 2 (adaptive SBRT)

MRI-guided Stereotactic Body Radiation Therapy RADIATION

Undergo MRI-guided SBRT

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

Arm 1 (non-adaptive SBRT); Arm 2 (adaptive SBRT)

Survey Administration OTHER

Ancillary studies

Arm 1 (non-adaptive SBRT); Arm 2 (adaptive SBRT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm 1 (non-adaptive SBRT); Arm 2 (adaptive SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Viewray Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; 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)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Amar W. Kishan, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol W. Felix

CONTACT

310-825-9771; cfelix@mednet.ucla.edu

Christy Palodichuck

CONTACT

+1 310-794-2971; cpalodichuk@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This block size will be blinded to the radiation oncology research team when enrolling a patient. The arm allocation will be masked until after the screening/baseline data are entered and filled out in Research Electronic Data Capture (REDCap) (no anticipation of the group assignment will be possible).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 11, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)