Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01441687
First received: September 23, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Conditions Influencing Health Status
Healthy
Prostate Cancer
Other: laboratory biomarker analysis
Procedure: transrectal prostate biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Perform TMPRSS2:ERG type III and TMPRSS2:ERG type IV assays on each specimen. The gold standard for assay validity is the biopsy result.

  • 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 ] [ Designated as safety issue: No ]
    The gold standard for assay validity is the biopsy result.

  • 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 ] [ Designated as safety issue: No ]
    The gold standard for assay validity is the biopsy result.

  • 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 ] [ Designated as safety issue: No ]
    The gold standard for assay validity is the biopsy result.


Estimated Enrollment: 180
Study Start Date: July 2009
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (PMU)
Patients receive digital rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then undergo a prostate biopsy.
Other: laboratory biomarker analysis
Correlative studies
Procedure: transrectal prostate biopsy
Undergo prostate biopsy
Experimental: Arm II (EPS)
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.
Other: laboratory biomarker analysis
Correlative studies
Procedure: transrectal prostate biopsy
Undergo prostate biopsy

Detailed Description:

OBJECTIVES:

I. 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)

V. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441687

Locations
United States, California
Chinn & Chinn Urology Associates, Inc. Recruiting
Arcadia, California, United States, 91006
Contact: Douglas O. Chinn, MD    626-574-7111      
Principal Investigator: Douglas O. Chinn         
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Timothy Wilson, MD    800-826-4673    twilson@coh.org   
Principal Investigator: Timothy null. Wilson         
Citrus Valley Urologic Medical Group Recruiting
Glendora, California, United States, 91741
Contact: Edward Davis, MD    626-335-0228      
Principal Investigator: Edward null. Davis         
Dr. Felix Chi-Ming Yip Recruiting
Monterey Park, California, United States, 91754
Contact: Felix Chi-Ming null. Yip    213-687-3388    cs@healthgrades.com   
Principal Investigator: Felix Chi-Ming null. Yip         
City of Hope- South Pasadena Cancer Center Recruiting
South Pasadena, California, United States, 91030
Contact: Roger W. Satterthwaite    626-396-2900    rsatterthwaite@coh.org   
Principal Investigator: Roger W. Satterthwaite         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Timothy Wilson City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01441687     History of Changes
Other Study ID Numbers: 08239, NCI-2011-01109
Study First Received: September 23, 2011
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by City of Hope Medical Center:
Health status unknown
healthy,no evidence of disease

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014