Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02479945

Enrollment

Registered

2015-06-24

Start date

2012-01-31

Completion date

2013-04-25

Last updated

2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

OTHERObtaining biospecimen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of Adverse Events	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026