Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments dna analysis, dna methylation analysis, rna analysis, gene expression analysis, polymerase chain reaction, diagnostic laboratory biomarker analysis, therapeutic conventional surgery
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date November 2007
End date November 2017
Trial size 1200 participants
Trial identifier NCT00977457, 06072, 5R01CA102521, CDR0000644208, CHNMC-06072, NCI-2011-00980, P30CA033572

Summary

This trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of prostate cancer

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
dna analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
dna methylation analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
rna analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
gene expression analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
polymerase chain reaction
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
diagnostic laboratory biomarker analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
therapeutic conventional surgery Undergo robotic prostatectomy or cystoprostatectomy

Primary Outcomes

Measure
Performance of these models in predicting the likelihood of BCR
time frame: Visit 2 (intraoperative setting)

Secondary Outcomes

Measure
Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery
time frame: Visit 2 (intraoperative setting)
Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance
time frame: Visit 2 (intraoperative setting)
Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens
time frame: Visit 2 (intraoperative setting)

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - All men undergoing robotic prostatectomy or cystoprostatectomy at City of Hope will be eligible for the study Exclusion Criteria: - Men who undergo neoadjuvant treatment with Androgen Deprivation Therapy (ADT) or salvage prostatectomy including those who have had brachytherapy will be excluded

Additional Information

Official title Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence
Principal investigator Steven S. Smith, PhD
Description PRIMARY OBJECTIVES: I. To explore the performance of these models in predicting the likelihood of biochemical recurrence (BCR). SECONDARY OBJECTIVES: I. To explore the performance of these models in predicting upgrading and upstaging prior to surgery. II. To explore the performance of these models in improving risk stratification among patients eligible for active surveillance. III. To determine whether prostatic massage or surgery raises the count of circulating tumor cells (CTC) in post-digital rectal exam (DRE) blood specimens. OUTLINE: Patients receive prostatic massage and undergo a digital rectal exam (DRE). Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.
Location data was received from the National Cancer Institute and was last updated in July 2016.