Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

PCA3 Assay

Jennifer Reid, PhD

The objective of this multi-center clinical study is to determine the association of the PCA3 Score with prostate biopsy outcome and validate the assay's performance characteristics in men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be associated with an increased likelihood of positive biopsy. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test.

PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing. Gen-Probe's PROGENSA(R) PCA3 assay is the first urine-based molecular diagnostic assay for prostate cancer.

Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result

Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result

The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score \>=25 was positive, PCA3 Score \<25 was negative

Gen-Probe, Incorporated

Our definition of at risk population is any unique subject who gave a post-digital rectal exam (DRE) urine sample, regardless of eligibility(n=498 of n=507 participants who started the study). n=106 of these subjects had a positive biopsy; n=389 had negative biopsy; n=3 had no biopsy.

PCA3 Assay : Post-DRE urine collected prior to prostate biopsy

Presence of prostate cancer defined by one or more positive biopsy cores

Subjects With Positive Biopsy Result

Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)

Subjects With Negative Biopsy Result

Subjects With no Biopsy Performed

PCA3 Assay : Post-DRE urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Jennifer Reid, Director of Clinical Affairs

All PCA3 Scores

PCA3 Score >=25

PCA3 Score <25

A total of n=466 subjects have valid and reportable PCA3 Scores and disease status (determined by biopsy result), and who were 50 years of age or older.

Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)

PCA3 Assay : Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.

Spots Global Cancer Trial Database for pca3

Every month we try and update this database with for pca3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pca3

Every month we try and update this database with for pca3 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pca3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.