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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| St. Olavs Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| relapse after radical treatment for prostate cancer | prostate cancer patients with biochemical relapse following radical treatment, or patients with persistently elevated PSA levels after radical prostatectomy, that have been (or will be) referred to PSMA PET/CT and PSMA PET/MRI at one of the participating hospitals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA PET/CT | Diagnostic Test | Whole-body PET/CT (contrast enhanced CT or low-dose CT); from vertex to thighs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection rates of prostate cancer recurrence after radical treatment using a standardized imaging protocol consisting of PSMA PET/CT and PET/MR | Consensus scoring and decision by nuclear medicine physician and radiologist on presence of local recurrent or metastatic lesions | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in detection rates between 68Ga- and 18F-PSMA tracers | Comparison of detection rates between the two radioisotopes based on consensus scoring | baseline |
| Differences in detection rates after radical treatment between whole-body PET/CT with and without PET/MR |
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Inclusion Criteria (surgery cohort):
Exclusion Criteria:
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Prostate cancer patients with biochemical relapse after radical treatment, or patients with persistently elevated PSA levels after radical prostatectomy, who have been (or will be) referred to standardized PSMA PET/CT and PSMA PET/MRI at one of the participating Norwegian hospitals.
Based on the local patient populations, 120 patients are expected to be included in Trondheim, 120 in Bergen, and 60 in Tromsø.
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| Name | Affiliation | Role |
|---|---|---|
| Øystein Risa, phd | NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging | Study Director |
| Edmund Søvik, md phd | St Olavs Hospital, Dept of Radiology and Nuclear Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Norway | ||||
| University Hospital of North Norway |
We will consider to openly share a completely anonymized dataset of the cohort at the end of the project
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009364 | Neoplasm Recurrence, Local |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| PSMA PET/MR | Diagnostic Test | Pelvic PET/MR in addition to targeted PET/MR according to other findings from the PET/CT (e.g. columna) |
|
Comparison of number of present local recurrent or metastatic lesions |
| baseline |
| Number of equivocal findings with and without addition of PET/MR to the whole-body PET/CT | Comparison of the number of local recurrent and metastatic lesions scored as equivocal | baseline |
| Detection rates of the combined PET/MR and PET/CT protocol compared with MRI-only. | Comparison of detection rates using MRI only compared to the detection rates based on consensus decision using the combined PET/MR and PET/CT protocol | 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 | Detection rates stratified according to PSA levels, kinetics and Gleason score | baseline |
| Inter-reader variability for interpretation of the PSMA PET/CT and PET/MR | Retrospective re-evaluation of images at minimum three sites | baseline |
| Detection of differences in image quality between participating centra | Image quality will be scored on a 5-point Likert Scale by a nuclear medicine physician and radiologist and compared between the centra | 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 | A reference standard based on evidence from histopathology, clinical follow-up and follow-up imaging will be established using criteria defining presence and absence of local recurrent and metastatic disease | baseline images and long term follow-up |
| Head to head comparison of uptake patterns of 68Ga- and 18F-PSMA | A selected subset of patients will be invited for a second imaging session. | baseline |
| Evaluation of locoregional PET-uptake according to primary radical treatment | Comparison of locoregional PET-uptake in patients treated with primary radiotherapy versus primary prostatectomy | baseline |
| Tromsø |
| Norway |
| St Olavs Hospital | Trondheim | Norway |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |