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

NCT04298112 | Completed

• 1 other identifier: 83009
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostatic Neoplasms

Keywords

Diagnostic Imaging; Positron-Emission Tomography; Magnetic Resonance Imaging; Prostate-Specific Antigen; Neoplasm Recurrence, Local

Outcome Measures

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

  Consensus scoring and decision by nuclear medicine physician and radiologist on presence of local recurrent or metastatic lesions

  baseline

Secondary Outcomes (10)

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

  baseline

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

  baseline

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

  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

Study Arms (1)

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.

Diagnostic Test: PSMA PET/CT; Diagnostic Test: PSMA PET/MR

Interventions

PSMA PET/CT DIAGNOSTIC_TEST

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

relapse after radical treatment for prostate cancer

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)

relapse after radical treatment for prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Haukeland University Hospital: collaborator
• University Hospital of North Norway: collaborator
• St. Olavs Hospital: collaborator

Study Sites (3)

Haukeland University Hospital

Bergen, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Recurrence, Local

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

NO (3)