NCT02076503

Brief Summary

Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients. The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

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

First Submitted

Initial submission to the registry

February 10, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

February 10, 2014

Last Update Submit

January 3, 2018

Conditions

Prostatic Neoplasms

Keywords

Neoplasm StagingPositron-Emission TomographyMagnetic Resonance Imaging1-amino-3-fluorocyclobutane-1-carboxylic acid

Outcome Measures

Primary Outcomes (1)

  • Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases

    Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases

    7 days

Study Arms (1)

PET-MR 18F-FACBC

EXPERIMENTAL
Procedure: PET-MR 18f-FACBCProcedure: histology (gold standard)

Interventions

PET-MR 18f-FACBCPROCEDURE
PET-MR 18F-FACBC
histology (gold standard)PROCEDURE

histopathological classification of co-located dissected lymph nodes

PET-MR 18F-FACBC

Eligibility Criteria

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

You may qualify if:

  • High-risk prostate cancer according to EAU guidelines (Gleason score ≥8 and/or PSA ≥20 ng/ml and/or ≥ cT3a cancer)
  • Eligibility for the surgical procedure (radical prostatectomy and bilateral pelvic lymph node resection)

You may not qualify if:

  • Previous treatment (for example TURP or hormone therapy)
  • Contraindication for the PET/MR examination (including, but not limited to: pacemaker, aneurysm clips, reduced renal function, metal implants, claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Urologic Surgery, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

  • Elschot M, Selnaes KM, Sandsmark E, Kruger-Stokke B, Storkersen O, Tessem MB, Moestue SA, Bertilsson H, Bathen TF. A PET/MRI study towards finding the optimal [18F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):695-703. doi: 10.1007/s00259-016-3562-7. Epub 2016 Nov 5.

    PMID: 27817158RESULT

  • Selnaes KM, Kruger-Stokke B, Elschot M, Willoch F, Storkersen O, Sandsmark E, Moestue SA, Tessem MB, Halvorsen D, Kjobli E, Angelsen A, Langorgen S, Bertilsson H, Bathen TF. 18F-Fluciclovine PET/MRI for preoperative lymph node staging in high-risk prostate cancer patients. Eur Radiol. 2018 Aug;28(8):3151-3159. doi: 10.1007/s00330-017-5213-1. Epub 2018 Jan 2.

    PMID: 29294158RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anders Angelsen, prof

    St. Olavs Hospital

    STUDY DIRECTOR

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

February 10, 2014

First Posted

March 3, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations

NO(1)