Prostatic Neoplasms
Conditions
Keywords
Prostate Cancer, Prostate Biopsy, PCA3
Brief summary
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.
Detailed description
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.
Interventions
OTHERPCA3 Assay
Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy
Sponsors
Gen-Probe, Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men 40+ years of age who have had at least 1 previous negative prostate biopsy, who have never had a positive prostate biopsy, and who have been recommended for a repeat biopsy by their clinician. * The subject must be able to comprehend and sign an approved informed consent form and other applicable study enrollment documents
Exclusion criteria
* Use of medications or hormones that are known to affect serum PSA levels within 3 - 6 months of study enrollment * Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment * History of prostate cancer * History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary tract symptoms within 6 months of study enrollment * Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject * Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | At the time of biopsy | 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 |
Countries
United States
Participant flow
Recruitment details
507 male subjects were recruited from 14 clinical sites in the United States including academic institutions, community-based urology clinics and group health organizations.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 495 |
| Total | 495 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ineligible | 12 |
| Overall Study | missing results required for analysis | 17 |
| Overall Study | results not evaluable | 12 |
Baseline characteristics
| Characteristic | PCA3 Assay |
|---|---|
| Age Continuous | 66.7 years STANDARD_DEVIATION 8.3 |
| Region of Enrollment United States | 495 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 495 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 498 | 0 / 106 | 0 / 389 | 0 / 3 |
| serious Total, serious adverse events | 0 / 498 | 0 / 106 | 0 / 389 | 0 / 3 |
Outcome results
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
Time frame: At the time of biopsy
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PCA3 Assay | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | All PCA3 Scores | 466 participants |
| PCA3 Assay | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | PCA3 Score >=25 | 235 participants |
| PCA3 Assay | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | PCA3 Score <25 | 231 participants |
| Subjects With Positive Biopsy Result | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | PCA3 Score >=25 | 79 participants |
| Subjects With Positive Biopsy Result | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | PCA3 Score <25 | 23 participants |
| Subjects With Positive Biopsy Result | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | All PCA3 Scores | 102 participants |
| Subjects With Negative Biopsy Result | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | PCA3 Score <25 | 208 participants |
| Subjects With Negative Biopsy Result | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | PCA3 Score >=25 | 156 participants |
| Subjects With Negative Biopsy Result | Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) | All PCA3 Scores | 364 participants |