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

• Sponsor: Subei People's Hospital of Jiangsu Province (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03418207
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22.9
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: trans-perineal template-guided mapping biopsy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Study on the Spatial Distribution of Prostate Cancer by Modified Trans-perineal Template-guided Mapping Biopsy
• Actual Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2018
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Subei People's Hospital of Jiangsu province	Yangzhou	Jiangsu	China	225001

Sponsors and Collaborators

• Subei People's Hospital of Jiangsu Province

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Tran M, Thompson J, Böhm 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.

• Responsible Party: Xuefei Ding,MD, Chief physician of urology, Subei People's Hospital of Jiangsu Province
• ClinicalTrials.gov Identifier: NCT03418207
• Other Study ID Numbers: SubeiPHJP
• First Posted: Feb 1, 2018
• Last Update Posted: Mar 29, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xuefei Ding,MD, Chief physician of urology, Subei People's Hospital of Jiangsu Province: TPS system; trans-perineal template-guided mapping biopsy; prostate cancer; spatial distribution; large tissue slice
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 29, 2018