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CompletedNCT02076503Updated Jan 5, 2018

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

An interventional study of PET-MR 18f-FACBC and histology (gold standard) in Prostatic Neoplasms, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to male participants. Per ClinicalTrials.gov, last updated 2018-01-05.

Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostatic Neoplasms

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Keywords

  • Neoplasm Staging
  • Positron-Emission Tomography
  • Magnetic Resonance Imaging
  • 1-amino-3-fluorocyclobutane-1-carboxylic acid
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In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 28 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.

Browse St. Olavs Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    PET-MR 18F-FACBC

    Procedure: PET-MR 18f-FACBC · Procedure: histology (gold standard)

Interventions

  • ProcedurePET-MR 18f-FACBC
  • Procedurehistology (gold standard)

    histopathological classification of co-located dissected lymph nodes

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What researchers measure

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

    Time frame: 7 days

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Study locations

1 site
  • Dept Urologic Surgery, St Olavs Hospital
    Trondheim, Norway
08

References and documents

Publications

  • 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. PubMed 27817158 ↗
  • 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. PubMed 29294158 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02076503
Lead sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Norwegian Cancer Society
Responsible party
Sponsor
First posted
Mar 3, 2014
Start date
Apr 2014
Primary completion
May 2015
Completion
May 2015
Last update
Jan 5, 2018

Study contacts

Anders Angelsen, prof
study director · St. Olavs Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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