Genetic Testing in Predicting Biomarkers of Recurrence in Patients With Prostate Cancer Undergoing Surgery

Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence

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

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: therapeutic conventional surgery; Genetic: DNA analysis; Genetic: DNA methylation analysis; Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Other: diagnostic laboratory biomarker analysis

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1045
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010-3000
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (specimen collection); 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.

Procedure: therapeutic conventional surgery; Other Names: Undergo robotic prostatectomy or cystoprostatectomy; Genetic: DNA analysis; Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery; Genetic: DNA methylation analysis; Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery; Genetic: RNA analysis; Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery; Genetic: gene expression analysis; Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery; Genetic: polymerase chain reaction; Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery; Other: diagnostic laboratory biomarker analysis; Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of these models in predicting the likelihood of BCR	Logistic regression and artificial neural networks will be used.	Visit 2 (intraoperative setting)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery	Logistic regression and artificial neural networks will be used.	Visit 2 (intraoperative setting)
Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance	Logistic regression and artificial neural networks will be used.	Visit 2 (intraoperative setting)
Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens	Logistic regression and artificial neural networks will be used.	Visit 2 (intraoperative setting)

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steven S. Smith, PhD, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2007
• Primary Completion (Actual): July 13, 2016
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 12, 2009
• First Submitted That Met QC Criteria: September 12, 2009
• First Posted (Estimated): September 15, 2009

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: stage III prostate cancer; stage IV prostate cancer; stage I prostate cancer; stage II prostate cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: 06072; P30CA033572 (U.S. NIH Grant/Contract); CHNMC-06072; CDR0000644208 (Registry Identifier: NCI PDQ); 5R01CA102521 (U.S. NIH Grant/Contract); NCI-2011-00980 (Registry Identifier: NCI CTRP)