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

• Sponsor: Gen-Probe, Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01024959
• Collaborator: (none)
• Enrollment: 507
• Locations: 13
• Arm: 1
• Duration (Months): 8
• Patients Per Site: 39
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Other: PCA3 Assay	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 507 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCA3 Assay	Other: PCA3 Assay; Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HealthCare Partners Medical Group	Los Angeles	California	United States	90015
2	San Diego Clinical Trials	San Diego	California	United States	92120
3	South Florida Medical Research	Aventura	Florida	United States	33180
4	Specialists in Urology	Naples	Florida	United States	34102
5	Florida Urology Specialists	Sarasota	Florida	United States	34237
6	Metropolitan Urology, PSC	Jeffersonville	Indiana	United States	47130
7	Regional Urology Specialists, LLC	Shreveport	Louisiana	United States	71106
8	AccuMed Research Associates	Garden City	New York	United States	11530
9	TriState Urologic Services PSC Inc. dba The Urology Group	Cincinnati	Ohio	United States	45212
10	Columbus Urology Research, LLC	Columbus	Ohio	United States	43220
11	MD Anderson Cancer Center	Houston	Texas	United States	77030
12	Urology San Antonio Research	San Antonio	Texas	United States	78229
13	Virginia Urology	Richmond	Virginia	United States	23235

Sponsors and Collaborators

• Gen-Probe, Incorporated

Investigators

• Study Director: Jennifer Reid, PhD, Gen-Probe, Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gen-Probe, Incorporated
• ClinicalTrials.gov Identifier: NCT01024959
• Other Study ID Numbers: 2009PCA301
• First Posted: Dec 3, 2009
• Last Update Posted: Nov 12, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Gen-Probe, Incorporated: Prostate Cancer; Prostate Biopsy; PCA3
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

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.

Arm/Group Title	Prostate Cancer Gene 3 (PCA3) Assay
Arm/Group Description	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.
Period Title: Overall Study
STARTED	507
COMPLETED	466
NOT COMPLETED	41

Baseline Characteristics

Arm/Group Title	PCA3 Assay
Arm/Group Description	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.
Overall Participants	495
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.7 (8.3)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	495 100%
Region of Enrollment (participants) [Number]
United States	495 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	PCA3 Assay	Subjects With Positive Biopsy Result	Subjects With Negative Biopsy Result
Arm/Group Description	PCA3 Assay : Post-DRE urine collected prior to prostate biopsy	Presence of prostate cancer defined by one or more positive biopsy cores	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)
Measure Participants	466	102	364
All PCA3 Scores	466 94.1%	102 NaN	364 NaN
PCA3 Score >=25	235 47.5%	79 NaN	156 NaN
PCA3 Score <25	231 46.7%	23 NaN	208 NaN

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	PCA3 Assay		Subjects With Positive Biopsy Result		Subjects With Negative Biopsy Result		Subjects With no Biopsy Performed
Arm/Group Description	PCA3 Assay : Post-DRE urine collected prior to prostate biopsy		Presence of prostate cancer defined by one or more positive biopsy cores		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)
All Cause Mortality
	PCA3 Assay		Subjects With Positive Biopsy Result		Subjects With Negative Biopsy Result		Subjects With no Biopsy Performed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	PCA3 Assay		Subjects With Positive Biopsy Result		Subjects With Negative Biopsy Result		Subjects With no Biopsy Performed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/498 (0%)		0/106 (0%)		0/389 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	PCA3 Assay		Subjects With Positive Biopsy Result		Subjects With Negative Biopsy Result		Subjects With no Biopsy Performed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/498 (0%)		0/106 (0%)		0/389 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.