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

NCT03418207 | Unknown DMC

• 1 other identifier: SubeiPHJP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

TPS system; trans-perineal template-guided mapping biopsy; prostate cancer; spatial distribution; large tissue slice

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (1)

• the spatial distribution based on the large tissue slice technique

  2 years

Study Arms (1)

TTMB for patients

OTHER

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

Procedure: trans-perineal template-guided mapping biopsy

Interventions

trans-perineal template-guided mapping biopsy PROCEDURE

new super saturation of prostate biopsy technique

TTMB for patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients;
• yrs and older, and 90 yrs and younger;
• Rectal examination reveal prostate nodules;
• B ultrasound, CT or MRI find abnormal images;
• PSA\>4ng/ml, abnormal f/t ratio and PSAD

You may not qualify if:

• Abnormal coagulation function;
• Severe urinary tract infection;
• Serious cardiovascular and cerebrovascular disease

Sponsors & Collaborators

• Subei People's Hospital of Jiangsu Province: lead

Study Sites (1)

Subei People's Hospital of Jiangsu province

Yangzhou, Jiangsu, 225001, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 25682968 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Xuefei Ding, MD

  Subei People's Hospital of Jiangsu Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefei Ding, MD

CONTACT

18051061234; xuefeid@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of urology

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 1, 2018
• Study Start: February 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)