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NCT02313623 | RECRUITING | Prostate Cancer


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

Condition or disease

Prostate Cancer

Intervention/treatment

Prostate Fusion Biopsy

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 Type : OBSERVATIONAL
Estimated Enrollment : 600 participants
Official Title : MR-US Image Fusion Targeted Biopsy for Single-cell Prostate Cancer Research
Actual Study Start Date : 2013-07
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT02313623


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Locations


RECRUITING

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520

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