An observational study in Prostate Cancer, sponsored by Yale University. Completed at 1 site in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Yale University · Observational
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 600 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Patients with scheduled Artemis fusion biopsy will be recruited into this study.
Exclusion Criteria:
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
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.
Success Rate of Primary Prostate Cell Culture
how often are primary prostate cancer cells able to be grown in culture
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Yale University