Genetic Testing in Predicting Biomarkers of Recurrence in Patients With Prostate Cancer Undergoing Surgery
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Purpose
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
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Genetic: DNA analysis Genetic: DNA methylation analysis Genetic: RNA analysis Genetic: gene expression analysis Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence |
- Performance of this model in predicting the likelihood of BCR [ Time Frame: Visit 2 (intraoperative setting) ] [ Designated as safety issue: No ]Logistic regression and artificial neural networks will be used.
- Comparison of the performance of the model with the Gleason score determined on resected prostate specimens in the same cohort of patients [ Time Frame: Visit 2 (intraoperative setting) ] [ Designated as safety issue: No ]
- Differences in cellular content and molecular assay performance between post-massage urine (PMU) and expressed prostatic secretion (EPS) specimens from patients undergoing radical prostatectomy [ Time Frame: Visit 2 (intraoperative setting) ] [ Designated as safety issue: No ]
- Determination whether prostatic massage raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens [ Time Frame: Visit 2 (intraoperative setting) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | July 2007 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
Procedure: therapeutic conventional surgery
Other Name: Undergo robotic prostatectomy or cystoprostatectomy
|
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Medical Center 800-826-4673 | |
| Principal Investigator: Steven Smith, PhD | |
| Principal Investigator: | Steven S. Smith, PhD | City of Hope Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00977457 History of Changes |
| Other Study ID Numbers: | 06072, P30CA033572, CHNMC-06072, CDR0000644208, 5R01CA102521, NCI-2011-00980 |
| Study First Received: | September 12, 2009 |
| Last Updated: | March 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Recurrence Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013