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

NCT02313623 | Completed

• 1 other identifier: 1304011902
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Success Rate of Primary Prostate Cell Culture

  how often are primary prostate cancer cells able to be grown in culture

  2 years

Study Arms (1)

Patient Scheduled for Prostate Fusion Biopsies

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.

Procedure: Prostate Fusion Biopsy

Interventions

Prostate Fusion Biopsy PROCEDURE

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.

Patient Scheduled for Prostate Fusion Biopsies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with scheduled Artemis fusion biopsy will be recruited into this study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Research samples will be placed in separate, de-identified specimen jars. Following each case, investigators on this protocol will provide the de-identified specimen jars to collaborators to perform single-cell analysis. All clinical specimens will be handled by pathology according to existing protocols. Processing of the samples will include disassociated into a single cell suspension and culturing the sample. This suspension can be then placed onto a microfluidic device for processing. It is hypothesized that collection of samples in this manner will allow the comparison of molecular profiles with clinically accepted standards to impact prospective research on prostate cancer.

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

• Preston C Sprenkle, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: December 10, 2014
• Study Start: July 1, 2013
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)