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Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
PET-MR 18f-FACBC
histology (gold standard)
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring Neoplasm Staging, Positron-Emission Tomography, Magnetic Resonance Imaging, 1-amino-3-fluorocyclobutane-1-carboxylic acid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Sites / Locations

  • Dept Urologic Surgery, St Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET-MR 18F-FACBC

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 10, 2014
Last Updated
January 3, 2018
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Norwegian Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT02076503
Brief Title
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
Official Title
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Norwegian Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Neoplasm Staging, Positron-Emission Tomography, Magnetic Resonance Imaging, 1-amino-3-fluorocyclobutane-1-carboxylic acid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET-MR 18F-FACBC
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
PET-MR 18f-FACBC
Intervention Type
Procedure
Intervention Name(s)
histology (gold standard)
Intervention Description
histopathological classification of co-located dissected lymph nodes
Primary Outcome Measure Information:
Title
Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases
Description
Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases
Time Frame
7 days

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Angelsen, prof
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dept Urologic Surgery, St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27817158
Citation
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.
Results Reference
result
PubMed Identifier
29294158
Citation
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.
Results Reference
result

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Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status

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