Feasibility study – Identification of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy

Phase 3

Completed

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12616000186459
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1.Male patients with pathologically diagnosed prostate cancer
2.Biochemical Recurrence as defined:
a.PSA > 0.2ng/ml on at least 2 occasions post radical prostatectomy
b.PSA 2.0ng/ml above nadir 2 years post radiotherapy
3.History of primary treatment for prostate cancer no sooner than 3 months post-surgery and 2 years post radiotherapy
4.No known problems with peripheral intravenous or central line access
5.Able to provide informed signed consent

Exclusion Criteria

1.Age under 18 years
2.Administered a radioisotope within 5 physical half-lives prior to study enrolment
3.Unable to lie flat during or unable to tolerate PET/MRI
4.Prior history of any other malignancy within last 2 years
5.Contraindication to PET scan or [68Ga]Gallium-labelled PSMA ligand
6.Claustrophobia not manageable by oral sedatives i.e. Temazepam
7.Renal impairment or haemodialysis.
8.Contraindication to biopsy of identified lesion
9. Contraindication to MRI such as implantable medical devices
10. Body weight above 150kg or axial diameter larger than 60cm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The accuracy (sensitivity and specificity) of PSMA PET/MRI in detecting metastatic or locally recurrent lesion in participants with biochemical recurrence post primary treatment of prostate cancer. The results of the PSMA PET/MRI scan will be compared to other imaging modality available e.g. staging CT, bone scan or standard MRI of the recurrence site which is needed for clinical management. The results of the PSMA PET/MRI scan will also be compared to the histology report of the PSMA PET/MRI positive specimen if there is a clinical need to take out the PET/MRI positive tissue. [After the PSMA PET/MRI has been performed or the PSMA PET/MRI positive specimens have been histopathologically analysed.]

Secondary Outcome Measures

Name	Time	Method
The utility of hybrid PET/MRI scan compared to standard imaging modalities in altering the management of patients from the standard of care by review of medical records and by interview with treating physician.[At the end of the study]