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Genetic Testing

Genetic Testing for Prostate Cancer Recurrence

Phase 1
Waitlist Available
Led By Steven S. Smith, PhD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2 (intraoperative setting)
Awards & highlights

Summary

This trial is testing the side effects and best way to perform genetic testing to predict the recurrence of prostate cancer in patients who have undergone surgery.

Who is the study for?
This trial is for men with prostate cancer scheduled for robotic surgery at City of Hope. It's not open to those who've had hormone therapy, salvage prostatectomy, or seed implant radiation before the surgery.
What is being tested?
The study is testing how well genetic tests can predict cancer recurrence after prostate surgery. It involves analyzing patients' tissue, blood, and other fluids using various laboratory techniques like DNA/RNA analysis.
What are the potential side effects?
Since this trial focuses on genetic testing rather than treatment, it doesn't involve direct side effects from interventions like drugs or therapies. However, there may be minimal risks associated with sample collection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (intraoperative setting)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 (intraoperative setting) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Performance of these models in predicting the likelihood of BCR
Secondary study objectives
Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery
Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance
Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens

Side effects data

From 2013 Phase 1 & 2 trial • 14 Patients • NCT01281865
75%
Anemia
75%
Hyperglycemia
75%
Platelet count decreased
67%
Hypertriglyceridemia
67%
White blood cell decreased
67%
Hypophosphatemia
58%
Aspartate aminotransferase increased
58%
Cholesterol high
42%
Fatigue
42%
Hypokalemia
42%
Alanine aminotransferase increased
33%
Hypoalbuminemia
33%
Lymphocyte count decreased
33%
Mucositis-oral
33%
Alkaline phosphatase increased
25%
Diarrhea
25%
Creatinine increased
25%
Neutrophil count decreased
25%
Rash maculo-papular
17%
Hypernatremia
17%
Blood bilirubin increased
17%
Hypocalcemia
17%
Nausea
8%
Intra-abdominal hemorrhage
8%
Constipation
8%
Dyspnea
8%
Papulopustular rash
8%
Peripheral sensory neuropathy
8%
Pneumonitis
8%
Tumor pain
8%
Anorexia
8%
Cough
8%
Hyponatremia
8%
Skin and subcutaneous tissue disorders Other, specify-dry split fingernails
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
Arm 2-Treatment (Everolimus and Imatinib Mesylate)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (specimen collection)Experimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DNA methylation analysis
2007
Completed Phase 3
~2210
therapeutic conventional surgery
2003
Completed Phase 3
~12900
RNA analysis
2011
Completed Phase 2
~880
gene expression analysis
2006
Completed Phase 2
~2030
DNA analysis
2007
Completed Phase 2
~6450
polymerase chain reaction
2006
Completed Phase 2
~1700

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,001,955 Total Patients Enrolled
566 Trials studying Prostate Cancer
528,764 Patients Enrolled for Prostate Cancer
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,922,492 Total Patients Enrolled
14 Trials studying Prostate Cancer
4,588 Patients Enrolled for Prostate Cancer
Steven S. Smith, PhDPrincipal InvestigatorCity of Hope Medical Center

Media Library

Diagnostic Laboratory Biomarker Analysis (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT00977457 — Phase 1
Prostate Cancer Research Study Groups: Diagnostic (specimen collection)
Prostate Cancer Clinical Trial 2023: Diagnostic Laboratory Biomarker Analysis Highlights & Side Effects. Trial Name: NCT00977457 — Phase 1
Diagnostic Laboratory Biomarker Analysis (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00977457 — Phase 1
~59 spots leftby Sep 2025
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