Choline PET/CT vs. Dual Time Point FDG PET/CT in Prostate Cancer
1 other identifier
interventional
20
1 country
1
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 Dual time point FDG 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Nov 2014
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2014
CompletedFirst Posted
Study publicly available on registry
September 5, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedOctober 25, 2018
October 1, 2018
3.1 years
September 3, 2014
October 23, 2018
Conditions
Keywords
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)
Dual time point FDG PET/CT
EXPERIMENTALCholine PET/CT and dual time point FDG PET/CT
Interventions
Choline PET/CT and dual time point FDG PET/CT
Eligibility Criteria
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 \> 7 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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, 2014
Primary Completion
December 1, 2017
Study Completion
February 1, 2018
Last Updated
October 25, 2018
Record last verified: 2018-10