NCT02747563

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

April 19, 2016

Last Update Submit

April 20, 2016

Conditions

Prostate Cancer

Keywords

prostate cancerPSAdigital rectal examination

Outcome Measures

Primary Outcomes (1)

  • Percentage of PSA elevation after DRE

    1 hour

Study Arms (2)

Active Surveillance

EXPERIMENTAL

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

Other: Blood test (PSA)

Controls

ACTIVE COMPARATOR

Patients without known diagnosis of prostate cancer Intervention - PSA measurement

Other: Blood test (PSA)

Interventions

Blood test (PSA)OTHER

Measurement of blood PSA levels

Active SurveillanceControls

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Uri Lindner, M.D.

CONTACT

urili@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Uri Lindner, Staff Urologist, Kaplan Medical Center

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 21, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

April 21, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)