Evaluation of PSA Blood Levels Prior to and After Digital Rectal Examination

April 20, 2016 updated by: Dr Uri Lindner, Kaplan Medical Center

Evaluation of PSA Blood Levels in Men on Active Surveillance and Men With Benign Prostatic Hyperplasia Prior to and After Digital Rectal Examination

Patients with know prostate cancer (PCa) under active surveillance and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with know prostate cancer (PCa) under active surveillance (Gleason 6, PSA < 10 ng/ml) and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination.

The change of PSA will be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Rehovot, Israel
        • Kaplan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males
  • Intact Rectum
  • Prostate Cancer eligible for active surveillance

Exclusion Criteria:

  • Pror radiation therapy
  • Under Androgen Deprivation Therapy
  • Prior prostate surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Surveillance
Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement
Other: Blood test (PSA)
Measurement of blood PSA levels
Active Comparator: Controls
Patients without known diagnosis of prostate cancer Intervention - PSA measurement
Other: Blood test (PSA)
Measurement of blood PSA levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of PSA elevation after DRE
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaplan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0210-15-KMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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