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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 2 (intraoperative setting)

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

Intra-abdominal hemorrhage

Constipation

Dyspnea

Papulopustular rash

Peripheral sensory neuropathy

Pneumonitis

Tumor pain

Anorexia

Cough

Hyponatremia

Skin and subcutaneous tissue disorders Other, specify-dry split fingernails

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1-Treatment (Everolimus and Imatinib Mesylate)

Arm 2-Treatment (Everolimus and Imatinib Mesylate)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

therapeutic conventional surgery

2003

Completed Phase 3

~12900

DNA methylation analysis

2007

Completed Phase 3

~2210