PET-MR-PSA Prostate Cancer Recidive Study

Prostate Cancer Recurrent Clinical Trial

— PET-MR-PSA  

Official title:

18F-Fluciclovine PET/MRI for Detection of Recurrent Prostate Cancer After Radical Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02562131
• Other study ID #: 2015/163-4
• Status: Active, not recruiting
• Start date: September 2015
• Est. completion date: December 2027

Study information

• Verified date: March 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The patients follow standard treatment and follow-up after the PET/MRI exam, which will be determined by the patient's treating urologist and/or oncologist. Data from histopathology, clinical follow-up and follow-up imaging will be collected to establish a reference standard that defines the presence or absence of disease for each patient. The imaging findings will be compared with the reference standard to assess the sensitivity and specificity. The diagnostic accuracy of combined PET/MRI and MRI-only (the current clinical standard) will be compared.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms

Locations

Country	Name	City	State
Norway	St Olavs Hospital, PET center	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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