Your session is about to expire
← Back to Search
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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2 (intraoperative setting)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (intraoperative setting)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Performance of these models in predicting the likelihood of BCR
Secondary outcome measures
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 • NCT0128186575%
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
RNA analysis
2011
Completed Phase 2
~880
therapeutic conventional surgery
2003
Completed Phase 3
~12270
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?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,920,415 Total Patients Enrolled
13 Trials studying Prostate Cancer
4,568 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,108 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,128 Patients Enrolled for Prostate Cancer
Steven S. Smith, PhDPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (specimen collection)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently being accepted to participate in this research?
"Based on the information found at clinicaltrials.gov, this particular trial is not currently seeking more patients. Despite having first been posted in November 2007 with a recent update occurring in March 2022, other trials are available that require participation right now: 2303 to be exact."
Answered by AI
Is the use of laboratory biomarkers for diagnostics endorsed by the FDA?
"Due to the limited research and data, diagnostic laboratory biomarker analysis was scored a 1 on our team's safety scale. This is likely because it is currently in its initial testing phase."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger