Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
Brief 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
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.
Interventions
GENETICDNA analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
GENETICDNA methylation analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
GENETICRNA analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
GENETICgene expression analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
GENETICpolymerase chain reaction
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
OTHERdiagnostic laboratory biomarker analysis
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
PROCEDUREtherapeutic conventional surgery
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of these models in predicting the likelihood of BCR | Visit 2 (intraoperative setting) | Logistic regression and artificial neural networks will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance | Visit 2 (intraoperative setting) | Logistic regression and artificial neural networks will be used. |
| Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens | Visit 2 (intraoperative setting) | Logistic regression and artificial neural networks will be used. |
| Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery | Visit 2 (intraoperative setting) | Logistic regression and artificial neural networks will be used. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven S. Smith, PhD
City of Hope Medical Center
Outcome results
None listed