Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer

NCT02479945 | Completed DMC

• 1 other identifier: UPCC 06811
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  1 year

Study Arms (1)

Selective internal iliac vein sampling

OTHER

Other: Obtaining biospecimen

Interventions

Obtaining biospecimen OTHER

Selective internal iliac vein sampling

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Micah Watts, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 24, 2015
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: April 25, 2013
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

US (1)