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

Phase 1

• Conditions: Prostate Cancer
• Interventions: Other: Blood test (PSA)

• Registration Number: NCT02747563
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-21
• Last Update Posted: 2016-04-21
• Study Start: 2016-05
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Surveillance	Blood test (PSA)	Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement
Controls	Blood test (PSA)	Patients without known diagnosis of prostate cancer Intervention - PSA measurement

Primary Outcome Measures

Name	Time	Method
Percentage of PSA elevation after DRE	1 hour

Trial Locations

Locations (1)

Kaplan Medical Center; 🇮🇱 Rehovot, Israel