Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer

NCT02425228 | Completed DMC

• 2 other identifiers: 14-000990JCCCID481
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

This is a pilot study to determine cancer detection rate of conventional/systematic versus targeted biopsy methods in diagnosis of potentially lethal prostate cancer. This is a diagnostic trial using each patient as his own control.

Conditions

Elevated PSA; Prostate Cancer

Keywords

targeted biopsy; conventional biopsy; cognitive biopsy

Outcome Measures

Primary Outcomes (1)

• Detection of clinically significant cancer

  Patient participation is only confined to the biopsy visit.

  one DAY

Interventions

Targeted biopsy DEVICE

conventional/systematic biopsy, targeted fusion biopsy and cognitive biopsy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with targetable lesion on MRI, undergoing a first-time prostate biopsy driven by PSA elevation to rule out cancer. We choose to study men undergoing first-time biopsy, since the great challenge with prostate biopsy today is to establish a correct diagnosis initially. The study sample is kept uniform by excluding men with prior negative biopsies and men enrolled in the Active Surveillance program. Men without a targetable lesion and men with a PI-RADS \<2 lesion currently undergo a mapping biopsy under an existing IRB approval; data collection on these men would continue in parallel, but would not be part of this targeting study

You may qualify if:

• Men undergoing a first-time prostate biopsy driven by PSA elevation to rule out cancer.
• PSA 2.5 - 20 ng/mL
• Prostate volume 20 - 100 cc
• No prior ablation or TURP
• Able to tolerate MRI
• T1c suspect
• Signed informed consent

You may not qualify if:

• Any prior prostate biopsy
• Active bleeding disorder or concurrent use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily stopped for at least 7 days before and 7 days after the biopsy
• Any prostate ablative procedure, including transurethral resection, photovaporization, or electrovaporization
• Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis) ,
• Palpable prostate mass lesion (i.e., Stage \>T1c suspected)
• Any condition that would preclude the subject from getting the required biopsy as stated in the protocol

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UCLA

Los Angeles, California, 90095, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 23, 2015
• Study Start: December 4, 2014
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: July 24, 2020

Record last verified: 2019-05

Locations

US (2)