PSMA-PET and MRI for Detection of Recurrent Prostate Cancer After Radical Treatment - a Multicenter Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostatic Neoplasms
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- Detection rates of prostate cancer recurrence after radical treatment using a standardized imaging protocol consisting of PSMA PET/CT and PET/MR
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Approximately one third of prostate cancer patients experience biochemical relapse following initial radical prostatectomy or curative radiotherapy. To determine further treatment, it is of utmost importance to accurately differentiate local and regional recurrence from distant metastatic disease. Unfortunately, the currently used medical imaging methods (MRI and bone scan) lack sensitivity for detection of nodal and skeletal metastases, which can lead to over-treatment of patients with occult metastatic disease. PET imaging with prostate specific membrane antigen (PSMA)-ligands has shown a promising potential for improving the detection accuracy in recurrent prostate cancer, especially when combined with the excellent soft-tissue contrast of MRI. However, evidence is mostly based on retrospective single center studies so far, including patients with a wide variety of PSA levels.
Improving the sensitivity for detection of metastatic disease is a crucial step in reducing over-treatment of prostate cancer patients with biochemical relapse following radical treatment. The purpose of this prospective multi-center study is to standardize PSMA PET/CT and PET/MRI imaging across three university hospitals in Norway, and investigate its merit for detection of recurrent prostate cancer. The long-term overall goal is offering prostate cancer patients a more personalized treatment plan aiming to improve the chances of survival and quality of life.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Previous salvage therapy for recurrent prostate cancer
- •General contra-indications for an MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia)
- •Serious concomitant systemic disorders or reduced cognitive functioning that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
- •Impaired renal function defined as estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2
- •Hormonal treatment during the last three months
Outcomes
Primary Outcomes
Detection rates of prostate cancer recurrence after radical treatment using a standardized imaging protocol consisting of PSMA PET/CT and PET/MR
Time Frame: baseline
Consensus scoring and decision by nuclear medicine physician and radiologist on presence of local recurrent or metastatic lesions
Secondary Outcomes
- Differences in detection rates after radical treatment between whole-body PET/CT with and without PET/MR(baseline)
- Sensitivity and specificity of the standardized whole-body PET/CT and targeted PET/MR protocol for detection of recurrence based on long-term clinical follow-up(baseline images and long term follow-up)
- Head to head comparison of uptake patterns of 68Ga- and 18F-PSMA(baseline)
- Evaluation of locoregional PET-uptake according to primary radical treatment(baseline)
- Number of equivocal findings with and without addition of PET/MR to the whole-body PET/CT(baseline)
- Differences in detection rates between 68Ga- and 18F-PSMA tracers(baseline)
- Detection rates of the combined PET/MR and PET/CT protocol compared with MRI-only.(baseline)
- Detection rate dependency on prostate specific antigen (PSA) level and kinetics at time of imaging in addition to Gleason score and stage of primary cancer(baseline)
- Inter-reader variability for interpretation of the PSMA PET/CT and PET/MR(baseline)
- Detection of differences in image quality between participating centra(baseline)