NCT02232672

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 of bone metastases are known to be inaccurate. Staging of lymph nodes requires surgery associated with risk of bleeding etc. 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 compare the usefulness of MeAIB PET/CT with current methods for the staging of bone and lymph node metastases 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 and non-invasive method of staging patients with undetected metastases on current staging will be spared of the side-effects associated with current treatment and staging- impotence, incontinence, radiation damage, bleeding, infection 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 Nov 2016

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withdrawn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

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
2.2 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

September 3, 2014

Last Update Submit

October 12, 2017

Conditions

Prostate Cancer

Keywords

Prostate CancerStagingPET/CT

Outcome Measures

Primary Outcomes (1)

  • Metastases to bone (yes/no) Metastases to lymph nodes (yes/no)

    1 day (At the time of scan interpretation)

Study Arms (1)

MeAIB PET/CT

EXPERIMENTAL

Choline PET/CT and MeAIB PET/CT

Device: Choline PET/CT and MeAIB PET/CT

Interventions

Choline PET/CT and MeAIB PET/CTDEVICE

Choline PET/CT and MeAIB PET/CT

MeAIB 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
  • Planned extended lymph node dissection 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
0

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

November 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

DK(1)