Prostatic NeoplasmsPCA3NCT01024959

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

A study testing PCA3 Assay in people with Prostatic Neoplasms, run by Gen-Probe, Incorporated at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Prostatic Neoplasms
What is being tested?: PCA3 Assay
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 507 participants
Where: 13 sitesUnited States
Study dates: Aug 2009to Apr 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

South Florida Medical Research
Aventura, Florida, 33180
TriState Urologic Services PSC Inc. dba The Urology Group
Cincinnati, Ohio, 45212
Columbus Urology Research, LLC
Columbus, Ohio, 43220
AccuMed Research Associates
Garden City, New York, 11530
MD Anderson Cancer Center
Houston, Texas, 77030
Metropolitan Urology, PSC
Jeffersonville, Indiana, 47130
HealthCare Partners Medical Group
Los Angeles, California, 90015
Specialists in Urology
Naples, Florida, 34102
Virginia Urology
Richmond, Virginia, 23235
Urology San Antonio Research
San Antonio, Texas, 78229
San Diego Clinical Trials
San Diego, California, 92120
Florida Urology Specialists
Sarasota, Florida, 34237
Regional Urology Specialists, LLC
Shreveport, Louisiana, 71106

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Prostatic Neoplasms
Being tested: PCA3 Assay
Keywords: Prostate Cancer, Prostate Biopsy, PCA3
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PCA3 AssayOther
Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

Study groups in NCT01024959
Study group	Role	What they receive
PCA3 Assay	Experimental	Not described Receives: Other: PCA3 Assay

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: At the time of biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Apr 2010

First posted3 Dec 2009 (estimated)
Study startAug 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 507 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01024959
Sponsor's protocol ID: 2009PCA301
Acronym: PCA3
Status last verified: Nov 2012
First submitted: 1 Dec 2009
Last updated: 12 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23416644

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result
ClinicalTrials.gov ID: NCT01024959
Acronym / sponsor ID: PCA3 / 2009PCA301
Conditions: Prostatic Neoplasms
Keywords: Prostate Cancer, Prostate Biopsy, PCA3
Study type: Interventional
Recruitment status: Completed
Enrolment: 507 participants (actual)
Lead sponsor: Gen-Probe, IncorporatedIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 3 Dec 2009 (estimated)
Results: Posted 7 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PCA3 Assay	Experimental	Other: PCA3 Assay

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PCA3 AssayPost-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy	Other	PCA3 Assay

Primary outcome

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

Results and safety

Results posted to the registry on 7 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prostate Cancer Gene 3 (PCA3) Assay	507	466

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

Time frame: At the time of biopsy. Number. Unit: participants

Measure	PCA3 Assay n = 466	Subjects With Positive Biopsy Result n = 102	Subjects With Negative Biopsy Result n = 364
All PCA3 Scores	466	102	364
PCA3 Score >=25	235	79	156
PCA3 Score <25	231	23	208

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCA3 Assay	0 of 498 (0%)	0 of 498 (0%)	Not reported
Subjects With Positive Biopsy Result	0 of 106 (0%)	0 of 106 (0%)	Not reported
Subjects With Negative Biopsy Result	0 of 389 (0%)	0 of 389 (0%)	Not reported
Subjects With no Biopsy Performed	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23416644Gittelman 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.

Related trials for Prostatic Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Reid, PhD study director

Gen-Probe, Incorporated

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PCA3 Assay in people with Prostatic Neoplasms, run by Gen-Probe, Incorporated at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) (time frame: At the time of biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01024959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.