Clinical trial NCT04298112: PSMA-PET and MRI for Detection of Recurrent Prostate Cancer After Radical Treatment
Official title: PSMA-PET and MRI for Detection of Recurrent Prostate Cancer After Radical Treatment - a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: Diagnostic Imaging
Positron-Emission Tomography
Magnetic Resonance Imaging
Prostate-Specific Antigen
Neoplasm Recurrence, Local
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: University Hospital of North Norway
name: St. Olavs Hospital
First posted: 2020-03-06
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria (surgery cohort):

* Prostate cancer patients with biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer; 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 loco-regional pelvic salvage treatment based on age and co-morbidity

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

Primary outcomes:
measure: Detection rates of prostate cancer recurrence after radical treatment using a standardized imaging protocol consisting of PSMA PET/CT and PET/MR
timeFrame: baseline
Secondary outcomes:
measure: Differences in detection rates between 68Ga- and 18F-PSMA tracers
timeFrame: baseline
measure: Differences in detection rates after radical treatment between whole-body PET/CT with and without PET/MR
timeFrame: baseline
measure: Number of equivocal findings with and without addition of PET/MR to the whole-body PET/CT
timeFrame: baseline
measure: Detection rates of the combined PET/MR and PET/CT protocol compared with MRI-only.
timeFrame: baseline
measure: 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
timeFrame: baseline
measure: Inter-reader variability for interpretation of the PSMA PET/CT and PET/MR
timeFrame: baseline
measure: Detection of differences in image quality between participating centra
timeFrame: baseline
measure: 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
timeFrame: baseline images and long term follow-up
measure: Head to head comparison of uptake patterns of 68Ga- and 18F-PSMA
timeFrame: baseline
measure: Evaluation of locoregional PET-uptake according to primary radical treatment
timeFrame: baseline
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging
name: Øystein Risa, phd
role: STUDY_DIRECTOR
affiliation: St Olavs Hospital, Dept of Radiology and Nuclear Medicine
name: Edmund Søvik, md phd
role: STUDY_DIRECTOR
References: