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MANTICORE Trial: Image-Guided Radiation for Localized Prostate Cancer

This study, called the MANTICORE Trial, is looking at a type of radiation treatment called stereotactic body radiation therapy (SBRT) for men with prostate cancer that hasn't spread. SBRT uses imaging like CT scans and MRI to precisely target the cancer. Typically, the radiation plan is set before treatment and not changed. This trial is comparing the usual SBRT to a new approach where the radiation plan is adjusted daily based on new images. Researchers want to see if this daily adjustment, called "online adaptation," reduces side effects related to urination. You may be eligible if you are 18 or older and have localized prostate adenocarcinoma. The study aims to enroll 186 participants.

Study design
This interventional study plans to enroll 186 participants who will be randomly assigned to one of two treatment groups.
What's involved
You would undergo blood sample collection, CT scans, MRI scans, and receive CT-guided SBRT with or without daily plan adaptation.
Compensation
Not stated in the trial record.
Follow-up
The primary side effects related to urination will be measured from the start of SBRT to 90 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276438

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

Recruiting
NAAges 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~186 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyCT-guided Stereotactic Body Radiation TherapyInter-fraction Adaptation of Treatment PlanMagnetic Resonance ImagingMRI-guided Stereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26)
Measured over From start of stereotactic body radiation therapy (SBRT) to 90 days following SBRT

Conditions

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

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Amar W. Kishan, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Carol W. Felix
[email protected]
310-825-9771
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26)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.