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

K

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)

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)

Trial contacts and locations

1

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Central trial contact

Uri Lindner, M.D.

Data sourced from clinicaltrials.gov

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