Conditions Influencing Health StatusNCT01441687
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
A study testing laboratory biomarker analysis and transrectal prostate biopsy in people with Conditions Influencing Health Status and Healthy, run by City of Hope Medical Center at 5 sites in United States.
Trial summary
This randomized pilot phase I trial studies the best way, either expressed prostatic secretion (EPS) or post massage urine (PMU) biomarkers, of predicting biopsy results in patients undergoing prostate biopsy. Studying samples of urine in the laboratory may help doctors detect prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Conditions Influencing Health Status, Healthy, Prostate Cancer
- What is being tested?
- laboratory biomarker analysis and transrectal prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Dec 2009to 3 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All men who will be undergoing transrectal ultrasound of the prostate (TRUSP) with biopsy in the department of Urology or participating urology clinics for the evaluation of prostate cancer
Who cannot join
- Men with a previous diagnosis of prostate cancer
- Men without a prior diagnosis of prostate cancer but who have previously undergone a biopsy for a suspicious DRE or PSA
- Men with a prior diagnosis of cancer < 5 years ago, excluding basal cell carcinoma and/or squamous cell carcinoma
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Chinn & Chinn Urology Associates, Inc.
Arcadia, California, 91006
City of Hope Medical Center
Duarte, California, 91010
Citrus Valley Urologic Medical Group
Glendora, California, 91741
Dr. Felix Chi-Ming Yip
Monterey Park, California, 91754
City of Hope- South Pasadena Cancer Center
South Pasadena, California, 91030
About this study
This randomized pilot phase I trial studies the best way, either expressed prostatic secretion (EPS) or post massage urine (PMU) biomarkers, of predicting biopsy results in patients undergoing prostate biopsy. Studying samples of urine in the laboratory may help doctors detect prostate cancer. It is not yet known whether EPS or PMU biomarkers are more effective in predicting prostate biopsy results
Read the detailed description
OBJECTIVES:
- To determine which non-invasive test for prostate cancer, EPS or PMU, is a better predictor of prostate cancer biopsy result. (Part I)
II. To determine whether standardized testing for transmembrane protease, serine 2 (TMPRSS2):ERG Types III and VI is superior to testing for TMPRSS2:ERG Type III in predicting prostate biopsy outcome. (Part I)
III. To expand the sample size utilizing the best TMPRSS2:ERG test and the best specimen type as determined in objective I and II in order to estimate with reasonable accuracy the positive predictive value (PPV) and negative predictive value (NPV) for each test. (Part II)
IV. To expand the biomarker set, to include Prostate Cancer Antigen 3 (PCA3)-ribonucleic acid (RNA), d-glyceraldehyde-3-phosphate dehydrogenase (GADPH)-RNA, prostate-specific antigen (PSA)-RNA, and deoxyribonucleic acid (DNA) methylation levels at glutathione s-transferase pi (GSTP1), adenomatous polyposis coli (APC), retinoic acid receptor beta (RARB), Mitochondrial DNA (MT-DNA) Deletions and ras association (RalGDS/AF-6) domain family 1 (RASSF1), so as to develop an extensive data set for use in multivariate analysis. (Part II)
- Use multivariate analysis to determine which combination of molecular markers offers the greatest improvements in our ability to predict biopsy outcome over current baseline predictors (Serum PSA and digital rectal examination [DRE]). (Part II)
VI. Estimate PPV and NPVs from this analysis and compare them to the standard assay's performance. (Part II)
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive digital rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then undergo a prostate biopsy.
ARM II: Patients receive DRE with prostatic massage for 30-60 seconds and are then milked at the urethra to provide a collection of EPS. Patients then undergo a prostate biopsy.
- Being tested
- laboratory biomarker analysis, transrectal prostate biopsy
- Keywords
- Health status unknown, healthy,no evidence of disease
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
transrectal prostate biopsyProcedure or surgery
Undergo prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PMU) | Experimental | Patients receive digital rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then undergo a prostate biopsy. Receives: Other: laboratory biomarker analysis; Procedure: transrectal prostate biopsy |
| Arm II (EPS) | Experimental | Patients receive DRE with prostatic massage for 30-60 seconds and are then milked at the urethra to provide a collection of EPS. Patients then undergo a prostate biopsy. Receives: Other: laboratory biomarker analysis; Procedure: transrectal prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether EPS or PMU is a better predictor of prostate cancer biopsy results by measuring and comparing the number of prostatic cells collected
Compare assay results in 300 EPS specimens with those from 300 PMU specimens. The gold standard for assay validity is the biopsy result.
Measured: 1 month after sample collection
Comparison of the area under the curve (AUC) for sensitivity and specificity of TMPRSS2:ERG single and double fusion assays and biopsy results in patients with prostate cancer, undergoing prostate screening
Perform TMPRSS2:ERG type III and TMPRSS2:ERG type IV assays on each specimen. The gold standard for assay validity is the biopsy result.
Measured: 1 month after sample collection
Secondary outcomes (3)
Comparison of the AUC for sensitivity and specificity of the methylation status of the androgen receptor (AR) and GSTP1 promoter, APC and RARB and biopsy results in men with prostate cancer, undergoing prostate screening
The gold standard for assay validity is the biopsy result.
Measured: 1 month after sample collection
Determine by comparison of AUCs which combination of molecular markers offers the greatest improvements in our ability to predict biopsy outcome over current baseline predictors (serum PSA and DRE)
The gold standard for assay validity is the biopsy result.
Measured: 1 month after sample collection
Comparison through the AUCs of the association of EPS or PMU TMPRSS2:ERG fusion assay and methylation of the GSTP1 promoter, APC, RARB assays and PCA3 to the results of TRUSP and biopsy in men with unknown prostate cancer status
The gold standard for assay validity is the biopsy result.
Measured: 1 month after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study start4 Dec 2009
- Primary completion30 Jun 2016
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions Influencing Health StatusStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven Smith, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441687
- Sponsor's protocol ID
- 08239
- Other IDs
- NCI-2017-00089
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2011
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
- ClinicalTrials.gov ID
- NCT01441687
- Acronym / sponsor ID
- 08239
- Keywords
- Health status unknown, healthy,no evidence of disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 243 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Dec 2009 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 3 Feb 2027 (estimated)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot phase I trial studies the best way, either expressed prostatic secretion (EPS) or post massage urine (PMU) biomarkers, of predicting biopsy results in patients undergoing prostate biopsy. Studying samples of urine in the laboratory may help doctors detect prostate cancer. It is not yet known whether EPS or PMU biomarkers are more effective in predicting prostate biopsy results
Detailed description
OBJECTIVES:
- To determine which non-invasive test for prostate cancer, EPS or PMU, is a better predictor of prostate cancer biopsy result. (Part I)
II. To determine whether standardized testing for transmembrane protease, serine 2 (TMPRSS2):ERG Types III and VI is superior to testing for TMPRSS2:ERG Type III in predicting prostate biopsy outcome. (Part I)
III. To expand the sample size utilizing the best TMPRSS2:ERG test and the best specimen type as determined in objective I and II in order to estimate with reasonable accuracy the positive predictive value (PPV) and negative predictive value (NPV) for each test. (Part II)
IV. To expand the biomarker set, to include Prostate Cancer Antigen 3 (PCA3)-ribonucleic acid (RNA), d-glyceraldehyde-3-phosphate dehydrogenase (GADPH)-RNA, prostate-specific antigen (PSA)-RNA, and deoxyribonucleic acid (DNA) methylation levels at glutathione s-transferase pi (GSTP1), adenomatous polyposis coli (APC), retinoic acid receptor beta (RARB), Mitochondrial DNA (MT-DNA) Deletions and ras association (RalGDS/AF-6) domain family 1 (RASSF1), so as to develop an extensive data set for use in multivariate analysis. (Part II)
- Use multivariate analysis to determine which combination of molecular markers offers the greatest improvements in our ability to predict biopsy outcome over current baseline predictors (Serum PSA and digital rectal examination [DRE]). (Part II)
VI. Estimate PPV and NPVs from this analysis and compare them to the standard assay's performance. (Part II)
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive digital rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then undergo a prostate biopsy.
ARM II: Patients receive DRE with prostatic massage for 30-60 seconds and are then milked at the urethra to provide a collection of EPS. Patients then undergo a prostate biopsy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (PMU) | Experimental | Other: laboratory biomarker analysis, Procedure: transrectal prostate biopsyPatients receive digital rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then undergo a prostate biopsy. |
| Arm II (EPS) | Experimental | Other: laboratory biomarker analysis, Procedure: transrectal prostate biopsyPatients receive DRE with prostatic massage for 30-60 seconds and are then milked at the urethra to provide a collection of EPS. Patients then undergo a prostate biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All men who will be undergoing transrectal ultrasound of the prostate (TRUSP) with biopsy in the department of Urology or participating urology clinics for the evaluation of prostate cancer
Key exclusion criteria (3 listed)
- Men with a previous diagnosis of prostate cancer
- Men without a prior diagnosis of prostate cancer but who have previously undergone a biopsy for a suspicious DRE or PSA
- Men with a prior diagnosis of cancer < 5 years ago, excluding basal cell carcinoma and/or squamous cell carcinoma
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Arm I (PMU), Arm II (EPS) |
| transrectal prostate biopsyUndergo prostate biopsy | Procedure or surgery | Arm I (PMU), Arm II (EPS) |
Primary outcome
Determine whether EPS or PMU is a better predictor of prostate cancer biopsy results by measuring and comparing the number of prostatic cells collected
Time frame: 1 month after sample collection
Compare assay results in 300 EPS specimens with those from 300 PMU specimens. The gold standard for assay validity is the biopsy result.
Comparison of the area under the curve (AUC) for sensitivity and specificity of TMPRSS2:ERG single and double fusion assays and biopsy results in patients with prostate cancer, undergoing prostate screening
Time frame: 1 month after sample collection
Perform TMPRSS2:ERG type III and TMPRSS2:ERG type IV assays on each specimen. The gold standard for assay validity is the biopsy result.
3 secondary outcomes
Comparison of the AUC for sensitivity and specificity of the methylation status of the androgen receptor (AR) and GSTP1 promoter, APC and RARB and biopsy results in men with prostate cancer, undergoing prostate screening
Time frame: 1 month after sample collection
Determine by comparison of AUCs which combination of molecular markers offers the greatest improvements in our ability to predict biopsy outcome over current baseline predictors (serum PSA and DRE)
Time frame: 1 month after sample collection
Comparison through the AUCs of the association of EPS or PMU TMPRSS2:ERG fusion assay and methylation of the GSTP1 promoter, APC, RARB assays and PCA3 to the results of TRUSP and biopsy in men with unknown prostate cancer status
Time frame: 1 month after sample collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
Steven Smith, PhD principal investigator
City of Hope Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laboratory biomarker analysis and transrectal prostate biopsy in people with Conditions Influencing Health Status and Healthy, run by City of Hope Medical Center at 5 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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
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?
Determine whether EPS or PMU is a better predictor of prostate cancer biopsy results by measuring and comparing the number of prostatic cells collected (time frame: 1 month after sample collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.