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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 2 May 2016
Main ID:  NCT02747563
Date of registration: 19/04/2016
Prospective Registration: Yes
Primary sponsor: Kaplan Medical Center
Public title: Evaluation of PSA Blood Levels Prior to and After Digital Rectal Examination
Scientific title: Evaluation of PSA Blood Levels in Men on Active Surveillance and Men With Benign Prostatic Hyperplasia Prior to and After Digital Rectal Examination
Date of first enrolment: May 2016
Target sample size: 60
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT02747563
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic  
Phase:  Phase 1
Countries of recruitment
Israel
Contacts
Name:     Uri Lindner, M.D.
Address: 
Telephone:
Email: urili@clalit.org.il
Affiliation: 
Name:     Uri Lindner, M.D.
Address: 
Telephone:
Email: urili@clalit.org.il
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Males

- Intact Rectum

- Prostate Cancer eligible for active surveillance

Exclusion Criteria:

- Pror radiation therapy

- Under Androgen Deprivation Therapy

- Prior prostate surgery



Age minimum: 18 Years
Age maximum: 99 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Prostate Cancer
Intervention(s)
Other: Blood test (PSA)
Primary Outcome(s)
Percentage of PSA elevation after DRE [Time Frame: 1 hour]
Secondary Outcome(s)
Secondary ID(s)
0210-15-KMC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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