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

Kaplan Medical Center

Status and phase: Unknown; Phase 1

Conditions: Prostate Cancer

Treatments: Other: Blood test (PSA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02747563

0210-15-KMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pror radiation therapy
• Under Androgen Deprivation Therapy
• Prior prostate surgery

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Active Surveillance

Experimental group

Description:

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

Treatment:

Other: Blood test (PSA)

Controls

Active Comparator group

Description:

Patients without known diagnosis of prostate cancer Intervention - PSA measurement

Treatment:

Other: Blood test (PSA)