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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02747563
• Other study ID #: 0210-15-KMC
• Status: Not yet recruiting
• Phase: Phase 1
• First received: April 19, 2016
• Last updated: April 20, 2016
• Start date: May 2016
• Est. completion date: May 2017

Study information

• Verified date: April 2016
• Source: Kaplan Medical Center
• Contact: Uri Lindner, M.D.
• Email: urili[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Males

• Intact Rectum

• Prostate Cancer eligible for active surveillance

Exclusion Criteria:

• Pror radiation therapy

• Under Androgen Deprivation Therapy

• Prior prostate surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Blood test (PSA)
Measurement of blood PSA levels

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of PSA elevation after DRE		1 hour	No