PSMA-PET and MRI for Detection of Recurrent Prostate Cancer After Radical Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2023-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PSMA PET/CT

Intervention Type DIAGNOSTIC_TEST

Whole-body PET/CT (contrast enhanced CT or low-dose CT); from vertex to thighs.

PSMA PET/MR

Intervention Type DIAGNOSTIC_TEST

Pelvic PET/MR in addition to targeted PET/MR according to other findings from the PET/CT (e.g. columna)

Interventions

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PSMA PET/CT

Whole-body PET/CT (contrast enhanced CT or low-dose CT); from vertex to thighs.

Intervention Type DIAGNOSTIC_TEST

PSMA PET/MR

Pelvic PET/MR in addition to targeted PET/MR according to other findings from the PET/CT (e.g. columna)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No