Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062423) titled 'A Study of Advanced Diffusion MRI for Improving the Diagnosis of Prostate Cancer' on July 31.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Prostate cancer or suspected prostate cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate the associations of IMPULSED-derived microstructural parameters obtained from time-dependent diffusion MRI using a high-performance 3-T MRI system with pathological tumor grade, conventional MRI findings, and clinical characteristics in prostate cancer, and to explore the utility of IMPULSED analysis for detecting clinically significant prostate cancer and assessing tumor aggressiveness. Basic objectives2 - Others

Intervention: Interventions/Control_1 - All participants will undergo non-contrast time-dependent diffusion MRI using the high-performance 3-T MRI system MAGNETOM Cima.X.

For participants undergoing clinically indicated prostate MRI, approximately 5 minutes of time-dependent diffusion MRI will be added immediately after the standard prostate MRI during the same examination session.

For participants who have already undergone clinically indicated prostate MRI at another institution or elsewhere and for whom repeat clinical prostate MRI at the study institution is considered unnecessary, non-contrast MRI consisting of basic prostate images required for research analysis and time-dependent diffusion MRI will be performed for approximately 10 minutes, principally during hospitalization.

No contrast agent, other investigational medication, blood sampling, or tissue sampling will be performed solely for this study.

If a participant undergoes clinically indicated prostate MRI more than once during the study period for treatment response assessment or follow-up, approximately 5 minutes of time-dependent diffusion MRI may be added at each clinically indicated MRI examination. Research MRI will not be repeated solely for the purpose of acquiring time-dependent diffusion MRI.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male Key inclusion criteria - 1. Male participants aged 20 years or older 2. Participants with suspected prostate cancer or those considered to require prostate MRI for the diagnosis of prostate cancer, treatment planning, treatment response assessment, or follow-up 3. Participants who meet either of the following conditions: Those scheduled to undergo clinically indicated prostate MRI at the study institution and able to undergo additional time-dependent diffusion MRI during the standard MRI examination Those who have already undergone clinically indicated prostate MRI, whose images are available for clinical use at the study institution, and for whom repeat clinical prostate MRI is considered unnecessary by the treating physician, but who are able to undergo research MRI during hospitalization 4. Participants who provide written informed consent to participate in the study Key exclusion criteria - 1. Participants who do not provide written informed consent 2. Participants younger than 20 years 3. Participants for whom MRI is contraindicated or considered inappropriate 4. Participants whose imaging data are considered unsuitable for analysis because of motion, metal-related artifacts, severe image distortion, interrupted image acquisition, or other causes 5. Participants considered unsuitable for participation by the principal investigator or a study investigator Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 23 Day Anticipated trial start date - 2026 Year 08 Month 17 Day Last follow-up date - 2031 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071434

Disclaimer: Curated by HT Syndication.