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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-06072 | |||
| CDR0000644208 | Registry Identifier | NCI PDQ | |
| 5R01CA102521 | U.S. NIH Grant/Contract | View source | |
| NCI-2011-00980 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (specimen collection) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA analysis | Genetic | Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery |
|
| 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) |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Steven S. Smith, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010-3000 | United States |
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| DNA methylation analysis | Genetic | Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery |
|
| RNA analysis | Genetic | Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery |
|
| gene expression analysis | Genetic | Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery |
|
| polymerase chain reaction | Genetic | Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery |
|
| diagnostic laboratory biomarker analysis | Other | Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery |
|
| therapeutic conventional surgery | Procedure |
|
|
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) |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019175 | DNA Methylation |
| D020869 | Gene Expression Profiling |
| D016133 | Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D008745 | Methylation |
| D000478 | Alkylation |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D055614 | Genetic Phenomena |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D021141 | Nucleic Acid Amplification Techniques |
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