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OpenTrials
Completed

NCT Number: NCT02479945

Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Obtaining biospecimen

Other

Primary outcomes

  1. Number of Adverse Events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 24, 2015
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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