Back to resultsPeripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Obtaining biospecimen
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- All male patients, age 18 to 99, with biopsy proven prostate adenocarcinoma prior to planned radical prostatectomy.
- Informed Consent/HIPAA Form discussed and signed by subject.
- Baseline lab values obtained within 120 days of planned selective venous sampling.
Exclusion Criteria:
- Skin related problems around the planned venepuncture site (infection, phlebitis, scars)
- Documented allergy to iodinated contrast or lidocaine.
- Coagulopathy with an INR of greater than 1.5
- Thrombocytopenia with platelets less than 25,000 uL
- Renal insufficiency with a creatinine of 1.5 mg/dL
- Documented current upper extremity or central venous thrombosis
- DRE within 4 weeks prior to selective venous sampling
- Prostate biopsy within 6 weeks prior to selective venous sampling.
- Patient unable to sign his own consent or does not demonstrate full understanding of the procedure.
- Patient has known metastatic disease or a known primary cancer other than prostate adenocarcinoma.
- Patient has already been enrolled in this research study.
- Life expectancy less than 6 months.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Selective internal iliac vein sampling
Arm Description
Outcomes
Primary Outcome Measures
Number of Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT02479945
First Posted
June 22, 2015
Last Updated
July 20, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02479945
Brief Title
Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer
Official Title
Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 25, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will compare tumor marker levels, including PSA, in samples taken from a peripheral upper limb vein and the internal iliac veins. These will be collected from patients who are scheduled for prostatectomy as part of their standard of care for prostate cancer. A selective internal iliac vein sampling procedure will be performed in Interventional Radiology. Venous samples will be correlated with prostatectomy specimens. The aim is to predict the side of the prostate containing tumor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selective internal iliac vein sampling
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Obtaining biospecimen
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All male patients, age 18 to 99, with biopsy proven prostate adenocarcinoma prior to planned radical prostatectomy.
Informed Consent/HIPAA Form discussed and signed by subject.
Baseline lab values obtained within 120 days of planned selective venous sampling.
Exclusion Criteria:
Skin related problems around the planned venepuncture site (infection, phlebitis, scars)
Documented allergy to iodinated contrast or lidocaine.
Coagulopathy with an INR of greater than 1.5
Thrombocytopenia with platelets less than 25,000 uL
Renal insufficiency with a creatinine of 1.5 mg/dL
Documented current upper extremity or central venous thrombosis
DRE within 4 weeks prior to selective venous sampling
Prostate biopsy within 6 weeks prior to selective venous sampling.
Patient unable to sign his own consent or does not demonstrate full understanding of the procedure.
Patient has known metastatic disease or a known primary cancer other than prostate adenocarcinoma.
Patient has already been enrolled in this research study.
Life expectancy less than 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Micah Watts, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer
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