PET-MR-PSA Prostate Cancer Recidive Study

NCT02562131 | Active Not Recruiting

• 1 other identifier: 2015/163-4
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high molecular sensitivity of PET in a single imaging session. The aim of this study is to evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for detection of recurrent prostate cancer.

Conditions

Prostate Cancer Recurrent

Keywords

PET-MR; recidive; PET/MR imaging; 18F-Fluciclovine; radical treatment; recurrence

Outcome Measures

Primary Outcomes (1)

• Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.

  Relevant patient information will be collected until 2027, 10 years after the last PET/MRI scan.

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The aim in 2 years is 80 prostate cancer patients with biochemical relapse following radical treatment, or patients with persistently elevated PSA levels after radical prostatectomy.

You may qualify if:

• the criteria for biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer must be fulfilled (two consecutive measurements with PSA \> 0.2 ng/ml following radical prostatectomy or PSA \> 2.0 ng/ml above the nadir following definitive radiotherapy)
• potential candidates for salvage treatment based on age and co-morbidity.

You may not qualify if:

• general contra-indications for a PET/MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia)
• impaired renal function defined as estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs Hospital, PET center

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tone F Bathen, PhD

  The Norwegian University of Science and Technology (NTNU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 29, 2015
• Study Start: September 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

NO (1)