Trial Outcomes & Findings for Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result (NCT NCT01024959)
NCT ID: NCT01024959
Last Updated: 2012-11-12
Results Overview
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
COMPLETED
NA
507 participants
At the time of biopsy
2012-11-12
Participant Flow
507 male subjects were recruited from 14 clinical sites in the United States including academic institutions, community-based urology clinics and group health organizations.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
507
|
|
Overall Study
COMPLETED
|
466
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
ineligible
|
12
|
|
Overall Study
results not evaluable
|
12
|
|
Overall Study
missing results required for analysis
|
17
|
Baseline Characteristics
Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
Baseline characteristics by cohort
| Measure |
PCA3 Assay
n=495 Participants
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
|
66.7 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
495 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
495 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of biopsyPopulation: 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.
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
Outcome measures
| Measure |
PCA3 Assay
n=466 Participants
PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
|
Subjects With Positive Biopsy Result
n=102 Participants
Presence of prostate cancer defined by one or more positive biopsy cores
|
Subjects With Negative Biopsy Result
n=364 Participants
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)
|
|---|---|---|---|
|
Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)
All PCA3 Scores
|
466 participants
|
102 participants
|
364 participants
|
|
Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)
PCA3 Score >=25
|
235 participants
|
79 participants
|
156 participants
|
|
Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)
PCA3 Score <25
|
231 participants
|
23 participants
|
208 participants
|
Adverse Events
PCA3 Assay
Subjects With Positive Biopsy Result
Subjects With Negative Biopsy Result
Subjects With no Biopsy Performed
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Reid, Director of Clinical Affairs
Gen-Probe, Incorporated
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60