NCT00542100

Brief Summary

The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the assessment of the prostate in humans. The study cohort will include 50 patients and is designed to be non-comparative to other diagnostic methods.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable prostate-cancer

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

October 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

October 7, 2007

Last Update Submit

October 9, 2007

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Efficacy of the PCMRI system in PC detection

    one year

  • Safety of the PCMRI system in PC detection

    one year

Secondary Outcomes (4)

  • Patient comfort

    one year

  • Compliance

    one year

  • Ease of use

    one year

  • Length of the test procedure

    one year

Study Arms (2)

1

EXPERIMENTAL
Device: PCMRI

2

EXPERIMENTAL
Device: PCMRI

Interventions

PCMRIDEVICE
12

Eligibility Criteria

Age25 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 45 and 80 years old.
  • Presumably Stage 2 and higher prostate carcinoma as determined by the PI.
  • At least 6 weeks after the last biopsy session.
  • Prior to any PC treatment. for control group:
  • Age between 25 and 35 years old.
  • No family history of PC.

You may not qualify if:

  • History of hemorrhoids.
  • History of prostetitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shmuel Cytron, MD.

    Barzilai Medical Center, Ashkelon, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2007

First Posted

October 10, 2007

Study Start

November 1, 2007

Study Completion

November 1, 2008

Last Updated

October 10, 2007

Record last verified: 2007-10