Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479945
• Other study ID #: UPCC 06811
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: April 25, 2013

Study information

• Verified date: July 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 25, 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. All male patients, age 18 to 99, with biopsy proven prostate adenocarcinoma prior to planned radical prostatectomy.

2. Informed Consent/HIPAA Form discussed and signed by subject.

3. Baseline lab values obtained within 120 days of planned selective venous sampling.

Exclusion Criteria:

1. Skin related problems around the planned venepuncture site (infection, phlebitis, scars)

2. Documented allergy to iodinated contrast or lidocaine.

3. Coagulopathy with an INR of greater than 1.5

4. Thrombocytopenia with platelets less than 25,000 uL

5. Renal insufficiency with a creatinine of 1.5 mg/dL

6. Documented current upper extremity or central venous thrombosis

7. DRE within 4 weeks prior to selective venous sampling

8. Prostate biopsy within 6 weeks prior to selective venous sampling.

9. Patient unable to sign his own consent or does not demonstrate full understanding of the procedure.

10. Patient has known metastatic disease or a known primary cancer other than prostate adenocarcinoma.

11. Patient has already been enrolled in this research study.

12. Life expectancy less than 6 months.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Obtaining biospecimen

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		1 year