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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Prostate Fusion Biopsy

• Registration Number: NCT02313623
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 600

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Scheduled for Prostate Fusion Biopsies	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.

Primary Outcome Measures

Name	Time	Method
Success Rate of Primary Prostate Cell Culture	2 years	how often are primary prostate cancer cells able to be grown in culture

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States