MR-US Image Fusion Targeted Biopsy for Single-cell Prostate Cancer Research

Prostate Cancer Clinical Trial

Official title:

MR-US Image Fusion Targeted Biopsy for Single-cell Prostate Cancer Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02313623
• Other study ID #: 1304011902
• Status: Recruiting
• Start date: July 2013
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Preston Sprenkle, MD
• Email: Preston.Sprenkle[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators hypothesize that this single-cell analysis can be used to evaluate prostate needle-core biopsies prospectively even in non-homogenous samples by providing profiles of proteomic and phenotypic signatures. These profiles will in turn enable better predictions of the malignant progression of prostate cancers in the settings of current clinical practice.

Description:

Current approaches for early detection and diagnosis include prostate-specific antigen (PSA) which is a useful, though not specific, biomarker for detecting prostate cancer. The suspected patients will be further sent for digital rectal examination(DRE), in which a doctor inserts a lubricated, gloved finger into the patient's rectum to feel for lumps, enlargements, or areas of hardness that might indicate prostate cancer. However, the only test that can fully confirm the diagnosis of prostate cancer is a biopsy - the removal of small pieces of the prostate for microscopic examination. If cancer is suspected using PSA test and DRE, more than 90% suspected patients choose undergo prostate biopsy. Prostate needle biopsies are routinely done on an outpatient basis and rarely require hospitalization. Markedly, the fine needle biopsy is minimally invasive and has currently been suggested for longitudinal monitoring of highly suspected patients or follow-up therapeutic responses. The large availability of biopsy samples for prostate cancer provides a cornerstone for the proposed patient specimen-based research. The investigators anticipate that comprehensive analysis rather than simple pathological examination of these samples will generate new insights to prostate tumor progression in human.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Only subjects that have scheduled Artemis prostate biopsy with defined regions of interest will be included in this study

Exclusion Criteria:

• Any subjects that are unable to provide informed consent will be excluded

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Prostate Fusion Biopsy
For subjects with scheduled fusion biopsies, we propose a research plan to acquire additional biopsy cores for research purposes without impacting clinical protocol. After acquiring clinically-necessary biopsies, we propose taking an additional research biopsy to establish a matched-pair of clinical and research samples.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate of Primary Prostate Cell Culture	how often are primary prostate cancer cells able to be grown in culture	2 years