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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Procedure: trans-perineal template-guided mapping biopsy

• Registration Number: NCT03418207
• Lead Sponsor: Subei People's Hospital of Jiangsu Province

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.

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-25
• Study Start: 2018-02-01
• Study First Posted: 2018-02-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TTMB for patients	trans-perineal template-guided mapping biopsy	give trans-perineal template-guided mapping biopsy for participants suspected prostate cancer

Primary Outcome Measures

Name	Time	Method
the spatial distribution based on the biopsy tissue	2 years	to simulate the spatial distribution of cancer based on the biopsy tissue contained cancer with the help of TPS system

Secondary Outcome Measures

Name	Time	Method
the spatial distribution based on the large tissue slice technique	2 years	to simulate the spatial distribution based on the large tissue slice technique after radical prostatectomy

Trial Locations

Locations (1)

Subei People's Hospital of Jiangsu province; 🇨🇳 Yangzhou, Jiangsu, China