NCT01745718

Brief Summary

The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer. It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue. The strategy is used in other types of cancer, e.g lung, breast etc

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

November 20, 2012

Last Update Submit

September 22, 2015

Conditions

Prostate Cancer

Keywords

prostate cancertargeted biopsiescytological imprintshistology

Outcome Measures

Primary Outcomes (1)

  • The rate of positive and negative cytological imprints, e.g presence of malignant cells or not.

    The cytological imprints will be compared to the histology of targeted biopsies (defined as gold standard). Measure of agreement, sensitivity and specificity will be calculated.

    15 months

Secondary Outcomes (1)

  • Interobserver variability

    15 months

Other Outcomes (1)

  • The detection rate of high grade cancer

    15 months

Study Arms (1)

MRI and targeted biopsies

OTHER

All patients receive the same level/number of diagnostic procedures. They all undergo targeted biopsies which are compared to the cytological imprints.

Other: Cytological imprints

Interventions

Cytological imprintsOTHER

Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients

MRI and targeted biopsies

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
  • No previous prostate biopsies
  • Positive MRI
  • Signed letter of informed concent

You may not qualify if:

  • Contraindications to MRI
  • Previous prostate biopsies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital , Aker

Oslo, 0514, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eduard Baco, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

December 10, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

NO(1)