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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
trans-perineal template-guided mapping biopsy
Sponsored by
Subei People's Hospital of Jiangsu Province
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring TPS system, trans-perineal template-guided mapping biopsy, prostate cancer, spatial distribution, large tissue slice

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Subei People's Hospital of Jiangsu provinceRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TTMB for patients

Arm Description

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

Outcomes

Primary Outcome Measures

the spatial distribution based on the biopsy tissue
to simulate the spatial distribution of cancer based on the biopsy tissue contained cancer with the help of TPS system

Secondary Outcome Measures

the spatial distribution based on the large tissue slice technique
to simulate the spatial distribution based on the large tissue slice technique after radical prostatectomy

Full Information

First Posted
January 23, 2018
Last Updated
March 27, 2018
Sponsor
Subei People's Hospital of Jiangsu Province
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1. Study Identification

Unique Protocol Identification Number
NCT03418207
Brief Title
The Accuracy of Modified TTMB in the Spatial Distribution of Prostate Cancer
Official Title
The Study on the Spatial Distribution of Prostate Cancer by Modified Trans-perineal Template-guided Mapping Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Subei People's Hospital of Jiangsu Province

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
TPS system, trans-perineal template-guided mapping biopsy, prostate cancer, spatial distribution, large tissue slice

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TTMB for patients
Arm Type
Other
Arm Description
give trans-perineal template-guided mapping biopsy for participants suspected prostate cancer
Intervention Type
Procedure
Intervention Name(s)
trans-perineal template-guided mapping biopsy
Intervention Description
new super saturation of prostate biopsy technique
Primary Outcome Measure Information:
Title
the spatial distribution based on the biopsy tissue
Description
to simulate the spatial distribution of cancer based on the biopsy tissue contained cancer with the help of TPS system
Time Frame
2 years
Secondary Outcome Measure Information:
Title
the spatial distribution based on the large tissue slice technique
Description
to simulate the spatial distribution based on the large tissue slice technique after radical prostatectomy
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Abnormal coagulation function; Severe urinary tract infection; Serious cardiovascular and cerebrovascular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefei Ding, MD
Phone
18051061234
Email
xuefeid@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuefei Ding, MD
Organizational Affiliation
Subei People's Hospital of Jiangsu Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefei Ding, MD
Phone
18051061234
Email
xuefeid@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25682968
Citation
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.
Results Reference
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The Accuracy of Modified TTMB in the Spatial Distribution of Prostate Cancer

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