Back to resultsEvaluation of PSA Blood Levels Prior to and After Digital Rectal Examination
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Blood test (PSA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, PSA, digital rectal examination
Eligibility Criteria
Inclusion Criteria:
- Males
- Intact Rectum
- Prostate Cancer eligible for active surveillance
Exclusion Criteria:
- Pror radiation therapy
- Under Androgen Deprivation Therapy
- Prior prostate surgery
Sites / Locations
- Kaplan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active Surveillance
Controls
Arm Description
Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement
Patients without known diagnosis of prostate cancer Intervention - PSA measurement
Outcomes
Primary Outcome Measures
Percentage of PSA elevation after DRE
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02747563
Brief Title
Evaluation of PSA Blood Levels Prior to and After Digital Rectal Examination
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaplan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, PSA, digital rectal examination
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Surveillance
Arm Type
Experimental
Arm Description
Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Patients without known diagnosis of prostate cancer Intervention - PSA measurement
Intervention Type
Other
Intervention Name(s)
Blood test (PSA)
Intervention Description
Measurement of blood PSA levels
Primary Outcome Measure Information:
Title
Percentage of PSA elevation after DRE
Time Frame
1 hour
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males
Intact Rectum
Prostate Cancer eligible for active surveillance
Exclusion Criteria:
Pror radiation therapy
Under Androgen Deprivation Therapy
Prior prostate surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Lindner, M.D.
Email
urili@clalit.org.il
Facility Information:
Facility Name
Kaplan Medical Center
City
Rehovot
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uri Lindner, M.D.
Email
urili@clalit.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of PSA Blood Levels Prior to and After Digital Rectal Examination
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