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Prostatic NeoplasmsNCT04298112

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

An observational study of Prostatic Neoplasms, run by Norwegian University of Science and Technology at 3 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
PSMA PET/CT and PSMA PET/MR
How many people
300 participants
Where
3 sitesNorway
Study dates
1 May 2020to 1 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Norway3 sites

  • Haukeland University Hospital

    Bergen

  • University Hospital of North Norway

    Tromsø

  • St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

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

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.

Being tested
PSMA PET/CT, PSMA PET/MR
Keywords
Diagnostic Imaging, Positron-Emission Tomography, Magnetic Resonance Imaging, Prostate-Specific Antigen, Neoplasm Recurrence, Local
Medical subject headings
Prostatic Neoplasms, Neoplasm Recurrence, Local

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSMA PET/CTDiagnostic test

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

  • PSMA PET/MRDiagnostic test

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

Study groups in NCT04298112
Study groupRoleWhat they receive
relapse after radical treatment for prostate cancerprostate 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.
Receives: Diagnostic Test: PSMA PET/CT; Diagnostic Test: PSMA PET/MR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline

Secondary outcomes (10)

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

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

    Measured: baseline

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

    Comparison of number of present local recurrent or metastatic lesions

    Measured: baseline

  3. 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

    Measured: baseline

  4. 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

    Measured: baseline

  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

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

    Measured: baseline

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

    Retrospective re-evaluation of images at minimum three sites

    Measured: baseline

  7. 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

    Measured: baseline

  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

    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

    Measured: baseline images and long term follow-up

  9. 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.

    Measured: baseline

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

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2020
  2. Study start1 May 2020
  3. Primary completion1 May 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04298112
Sponsor's protocol ID
83009
Status last verified
Apr 2024
First submitted
4 Mar 2020
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will consider to openly share a completely anonymized dataset of the cohort at the end of the project

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasms, run by Norwegian University of Science and Technology at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04298112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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