NCT02232685

Brief Summary

Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world. Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods for staging are known to be inaccurate. Prior studies from our department suggest that PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of this study is to test the usefulness of Choline PET/CT for the staging of bone metastases compared to current standard methods in patients with newly diagnosed prostate cancer. Better initial staging will result in better treatment of the individual patient. If we are able to develop a more accurate method of staging patients with undetected metastases on current staging will be spared of the side-effects associated with current treatment - impotence, incontinence, radiation damage etc.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

September 3, 2014

Last Update Submit

October 10, 2016

Conditions

Prostate Cancer

Keywords

Prostate cancerStagingPET/CT

Outcome Measures

Primary Outcomes (1)

  • Metastases to bone (yes/no)

    1 day (At the time of scan interpretation)

Study Arms (1)

Choline PET/CT

EXPERIMENTAL

18F-Choline PET/CT

Device: 18F-Choline PET/CT

Interventions

18F-Choline PET/CTDEVICE

18F-Choline PET/CT

Choline PET/CT

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed, histologically verified PCa and
  • Written consent and
  • PSA ≥ 20 ng/mL and/or
  • Gleason score \> 6 and/or
  • cT-stage ≥ cT2c

You may not qualify if:

  • Withdrawal of consent or
  • Other active malign disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospiatal

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 5, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

DK(1)