Conditions Influencing Health Status, Healthy, Prostate Cancer
Conditions
Keywords
Health status unknown, healthy,no evidence of disease
Brief 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. It is not yet known whether EPS or PMU biomarkers are more effective in predicting prostate biopsy results
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.
Interventions
OTHERlaboratory biomarker analysis
Correlative studies
PROCEDUREtransrectal prostate biopsy
Undergo prostate biopsy
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether EPS or PMU is a better predictor of prostate cancer biopsy results by measuring and comparing the number of prostatic cells collected | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 month after sample collection | 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) | 1 month after sample collection | 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 | 1 month after sample collection | The gold standard for assay validity is the biopsy result. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven Smith, PhD
City of Hope Medical Center
Outcome results
None listed