Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer

NCT ID: NCT02479945

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Selective internal iliac vein sampling

Group Type OTHER

Obtaining biospecimen

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Obtaining biospecimen

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Micah Watts, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UPCC 06811

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PSMA-Guided Ablation of the Prostate
NCT06003556 RECRUITING PHASE2
Early Detection of Prostate Cancer
NCT04556916 RECRUITING NA
PSMA-PET to Guide Prostatectomy
NCT05381103 RECRUITING PHASE2/PHASE3