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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCA3 Assay | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCA3 Assay | Other | Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | 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 | At the time of biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Reid, PhD | Gen-Probe, Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthCare Partners Medical Group | Los Angeles | California | 90015 | United States | ||
| San Diego Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23416644 | Derived | Gittelman MC, Hertzman B, Bailen J, Williams T, Koziol I, Henderson RJ, Efros M, Bidair M, Ward JF. PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study. J Urol. 2013 Jul;190(1):64-9. doi: 10.1016/j.juro.2013.02.018. Epub 2013 Feb 14. |
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507 male subjects were recruited from 14 clinical sites in the United States including academic institutions, community-based urology clinics and group health organizations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prostate Cancer Gene 3 (PCA3) Assay | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| San Diego |
| California |
| 92120 |
| United States |
| South Florida Medical Research | Aventura | Florida | 33180 | United States |
| Specialists in Urology | Naples | Florida | 34102 | United States |
| Florida Urology Specialists | Sarasota | Florida | 34237 | United States |
| Metropolitan Urology, PSC | Jeffersonville | Indiana | 47130 | United States |
| Regional Urology Specialists, LLC | Shreveport | Louisiana | 71106 | United States |
| AccuMed Research Associates | Garden City | New York | 11530 | United States |
| TriState Urologic Services PSC Inc. dba The Urology Group | Cincinnati | Ohio | 45212 | United States |
| Columbus Urology Research, LLC | Columbus | Ohio | 43220 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Urology San Antonio Research | San Antonio | Texas | 78229 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PCA3 Assay | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | 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 | 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. | Posted | Number | participants | At the time of biopsy |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCA3 Assay | PCA3 Assay : Post-DRE urine collected prior to prostate biopsy | 0 | 498 | 0 | 498 | ||
| EG001 | Subjects With Positive Biopsy Result | Presence of prostate cancer defined by one or more positive biopsy cores | 0 | 106 | 0 | 106 | ||
| EG002 | Subjects With Negative 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) | 0 | 389 | 0 | 389 | ||
| EG003 | Subjects With no Biopsy Performed | 0 | 3 | 0 | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Reid, Director of Clinical Affairs | Gen-Probe, Incorporated | 858-731-5985 | jennifer.reid@hologic.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Title | Measurements |
|---|---|
|
| PCA3 Score <25 |
|