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NCT Number: NCT04298112

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

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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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Recurrence, Local Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSMA PET/CT

Diagnostic Test

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

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)

Primary outcomes

  1. 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

  1. Differences in detection rates between 68Ga- and 18F-PSMA tracers

    Time frame: baseline

    Comparison of detection rates between the two radioisotopes based on consensus scoring

  2. Differences in detection rates after radical treatment between whole-body PET/CT with and without PET/MR

    Time frame: baseline

    Comparison of number of present local recurrent or metastatic lesions

  3. Number of equivocal findings with and without addition of PET/MR to the whole-body PET/CT

    Time frame: baseline

    Comparison of the number of local recurrent and metastatic lesions scored as equivocal

  4. Detection rates of the combined PET/MR and PET/CT protocol compared with MRI-only.

    Time frame: baseline

    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

  5. 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

    Time frame: baseline

    Detection rates stratified according to PSA levels, kinetics and Gleason score

  6. Inter-reader variability for interpretation of the PSMA PET/CT and PET/MR

    Time frame: baseline

    Retrospective re-evaluation of images at minimum three sites

  7. Detection of differences in image quality between participating centra

    Time frame: baseline

    Image quality will be scored on a 5-point Likert Scale by a nuclear medicine physician and radiologist and compared between the centra

  8. 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

    Time frame: baseline images and long term 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

  9. Head to head comparison of uptake patterns of 68Ga- and 18F-PSMA

    Time frame: baseline

    A selected subset of patients will be invited for a second imaging session.

  10. Evaluation of locoregional PET-uptake according to primary radical treatment

    Time frame: baseline

    Comparison of locoregional PET-uptake in patients treated with primary radiotherapy versus primary prostatectomy

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Haukeland University Hospital
  • St. Olavs Hospital
  • University Hospital of North Norway

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2020
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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