UMIN-ICDS Clinical Trial

Public title

A study comparing MRI before prostate cancer surgery with pathological findings after surgery

Acronym

MRI Before Prostate Cancer Surgery Study

Scientific Title

Comparison of IMPULSED diffusion MRI-derived parameters obtained using MAGNETOM Cima.X with histopathological findings of prostate cancer

Scientific Title:Acronym

IMPULSED Prostatectomy Study

Region

Japan

Condition

Prostate cancer

Classification by specialty

Urology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate associations between microstructural parameters derived from time-dependent diffusion MRI acquired before radical prostatectomy using the IMPULSED model and histopathological findings in radical prostatectomy specimens, and to explore their utility for detecting clinically significant prostate cancer and assessing its aggressiveness.

Basic objectives2

Others

Basic objectives -Others

Associations between MRI-derived microstructural parameters and histopathological aggressiveness of prostate cancer

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Associations between IMPULSED-derived microstructural parameters and histopathological aggressiveness. Research MRI acquired before radical prostatectomy is matched to routine postoperative histopathological findings in prostatectomy specimens on a lesion-by-lesion basis using specimen sectioning maps and anatomical landmarks. Associations with ISUP Grade Group, Gleason score, and the presence of clinically significant prostate cancer in matched lesions are evaluated. Lesions that cannot be matched are excluded from the corresponding lesion-level analysis, and the reasons are recorded. Selection and analytical handling of multiple lesions follow predefined analysis procedures.

Key secondary outcomes

Associations of IMPULSED-derived microstructural parameters with: (1) conventional MRI findings, including PI-RADS category, ADC, diffusion-weighted and T2-weighted imaging findings, and lesion size on MRI; (2) clinical information, including PSA, PSA density, prostate volume, clinical stage, and biopsy pathology; and (3) findings from other imaging examinations, including primary lesion location, degree of uptake, and findings of lymph node and distant metastases (exploratory). (4) Image quality and analytical stability: image quality, distortion, signal loss, motion and artifacts, reasons for analysis difficulties, and site-specific analysis success rates (exploratory). Research MRI is performed before radical prostatectomy, and information obtained in routine care is used.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

After written informed consent, participants are enrolled before research MRI. Research prostate MRI and time-dependent diffusion MRI are performed using MAGNETOM Cima.X according to a common acquisition protocol before radical prostatectomy, as close to surgery as possible. One research MRI examination is performed per participant. Total research MRI acquisition time is approximately 10 minutes, without research-related contrast administration. Imaging is generally performed during hospitalization for surgery or on a routine clinical visit, without a research-only visit. If imaging cannot be performed on these occasions, research MRI is not performed. Treatment is not altered, and no additional blood sampling or tissue collection is performed for research purposes.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

(1) Men aged 20 years or older. (2) Histologically diagnosed prostate cancer with planned radical prostatectomy. (3) Written informed consent to participate in this study.

Key exclusion criteria

(1) Written informed consent cannot be obtained. (2) MRI is contraindicated or considered inappropriate. (3) Preoperative treatment for prostate cancer has been administered, or is scheduled to be administered, before research MRI. (4) Participation is considered inappropriate by the principal investigator or a study investigator.

Target sample size

50

Name of lead principal investigator

1st name	Kota
Middle name
Last name	Yokoyama

Organization

Graduate School of Medical and Dental Sciences, Institute of Science Tokyo

Division name

Department of Diagnostic Radiology and Nuclear Medicine

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

03-5803-5311

Email

ykymdrnm@tmd.ac.jp

Name of contact person

1st name	Yusuke
Middle name
Last name	Kawasaki

Organization

Graduate School of Medical and Dental Sciences, Institute of Science Tokyo

Division name

Department of Diagnostic Radiology and Nuclear Medicine

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

03-5803-5311

Homepage URL

Email

kwskdrnm@tmd.ac.jp

Institute

Institute of Science Tokyo

Institute

Department

Personal name

Organization

Institute of Science Tokyo

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Siemens Healthcare K.K. (software and technical support only; no financial support)

Organization

Medical Research Ethics Committee of Institute of Science Tokyo

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

Tel

03-5803-4547

Email

rinri.adm@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京科学大学病院（東京都）、帝京大学医学部附属病院（東京都）

Date of disclosure of the study information

2026

Year

10

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

No plan to share individual participant data outside the research group.

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

27

Day

Date of IRB

Anticipated trial start date

2026

Year

12

Month

01

Day

Last follow-up date

2030

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

30

Day

Last modified on

2026

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072642