The Accuracy of Modified TTMB in the Spatial Distribution of Prostate Cancer

NCT ID: NCT03418207

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-12-31

Brief Summary

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Investigators plan to use modified TTMB technology to puncture prostate of participants suspected prostate cancer, especially those with the first negative biopsy , but having a rising PSA.Then, Investigators will simulate the spatial distribution of prostate cancer in patients with positive biopsy before radical prostatectomy by way of the TPS software system . And after the radical prostatectomy ,Investigators will simulate the spatial distribution with the help of large tissue slice technique to compare with preoperative simulation ,which to verify the two simulations are consistent.

Detailed Description

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Investigators mainly plan to determine the accuracy of the modified TTMB technology in combination with the TPS system on the location of the tumor space distribution by comparing the two simulation, which is significant for the accurate focal thearpy.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TTMB for patients

give trans-perineal template-guided mapping biopsy for participants suspected prostate cancer

Group Type OTHER

trans-perineal template-guided mapping biopsy

Intervention Type PROCEDURE

new super saturation of prostate biopsy technique

Interventions

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trans-perineal template-guided mapping biopsy

new super saturation of prostate biopsy technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1.Male patients;

2.18 yrs and older, and 90 yrs and younger;

3.Rectal examination reveal prostate nodules;

4.B ultrasound, CT or MRI find abnormal images;

5.PSA\>4ng/ml, abnormal f/t ratio and PSAD

Exclusion Criteria

1. Abnormal coagulation function;
2. Severe urinary tract infection;
3. Serious cardiovascular and cerebrovascular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Subei People's Hospital of Jiangsu Province

OTHER

Sponsor Role lead

Responsible Party

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Xuefei Ding,MD

Chief physician of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuefei Ding, MD

Role: PRINCIPAL_INVESTIGATOR

Subei People's Hospital of Jiangsu Province

Locations

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Subei People's Hospital of Jiangsu province

Yangzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuefei Ding, MD

Role: CONTACT

18051061234

Facility Contacts

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Xuefei Ding, MD

Role: primary

18051061234

References

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Tran M, Thompson J, Bohm M, Pulbrook M, Moses D, Shnier R, Brenner P, Delprado W, Haynes AM, Savdie R, Stricker PD. Combination of multiparametric MRI and transperineal template-guided mapping biopsy of the prostate to identify candidates for hemi-ablative focal therapy. BJU Int. 2016 Jan;117(1):48-54. doi: 10.1111/bju.13090. Epub 2015 May 11.

Reference Type BACKGROUND
PMID: 25682968 (View on PubMed)

Other Identifiers

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SubeiPHJP

Identifier Type: -

Identifier Source: org_study_id

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