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

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ClinicalTrials.gov Identifier: NCT02747563
Recruitment Status : Unknown
Verified April 2016 by Dr Uri Lindner, Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Uri Lindner, Kaplan Medical Center

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Blood test (PSA) Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of PSA Blood Levels in Men on Active Surveillance and Men With Benign Prostatic Hyperplasia Prior to and After Digital Rectal Examination
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percentage of PSA elevation after DRE [ Time Frame: 1 hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747563


Contacts
Contact: Uri Lindner, M.D. urili@clalit.org.il

Locations
Israel
Kaplan Medical Center Not yet recruiting
Rehovot, Israel
Contact: Uri Lindner, M.D.       urili@clalit.org.il   
Sponsors and Collaborators
Kaplan Medical Center

Responsible Party: Dr Uri Lindner, Dr. Uri Lindner, Staff Urologist, Kaplan Medical Center, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT02747563     History of Changes
Other Study ID Numbers: 0210-15-KMC
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr Uri Lindner, Kaplan Medical Center:
prostate cancer
PSA
digital rectal examination

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases