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

NCT ID: NCT02747563

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Active Surveillance

Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement

Group Type EXPERIMENTAL

Blood test (PSA)

Intervention Type OTHER

Measurement of blood PSA levels

Controls

Patients without known diagnosis of prostate cancer Intervention - PSA measurement

Group Type ACTIVE_COMPARATOR

Blood test (PSA)

Intervention Type OTHER

Measurement of blood PSA levels

Interventions

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Blood test (PSA)

Measurement of blood PSA levels

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pror radiation therapy
* Under Androgen Deprivation Therapy
* Prior prostate surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Kaplan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dr Uri Lindner

Dr. Uri Lindner, Staff Urologist, Kaplan Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaplan Medical Center

Rehovot, , Israel

Site Status

Countries

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Israel

Central Contacts

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Uri Lindner, M.D.

Role: CONTACT

Facility Contacts

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Uri Lindner, M.D.

Role: primary

Other Identifiers

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0210-15-KMC

Identifier Type: -

Identifier Source: org_study_id

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