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OpenTrials
Completed

NCT Number: NCT02313623

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Yale University

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Success Rate of Primary Prostate Cell Culture

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2014
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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