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

March 27, 2018 updated by: Xuefei Ding,MD, Subei People's Hospital of Jiangsu Province

The Study on the Spatial Distribution of Prostate Cancer by Modified Trans-perineal Template-guided Mapping Biopsy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Subei People's Hospital of Jiangsu province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: TTMB for patients
give trans-perineal template-guided mapping biopsy for participants suspected prostate cancer
Procedure: trans-perineal template-guided mapping biopsy
new super saturation of prostate biopsy technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the spatial distribution based on the biopsy tissue
Time Frame: 2 years
to simulate the spatial distribution of cancer based on the biopsy tissue contained cancer with the help of TPS system
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the spatial distribution based on the large tissue slice technique
Time Frame: 2 years
to simulate the spatial distribution based on the large tissue slice technique after radical prostatectomy
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Subei People's Hospital of Jiangsu Province

Investigators

  • Principal Investigator: Xuefei Ding, MD, Subei People's Hospital of Jiangsu province

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (ACTUAL)

February 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SubeiPHJP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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