NCT03537391: PROSTAGE

Novel Imaging in Staging of Primary Prostate Cancer

Completed NA Last updated 4 May 2022

What this trial tests

NA trial testing Whole body contrast enhanced computer tomography in High Risk Prostate Cancer in 80 participants. Completed in 2 May 2022.

Timeline

1 March 2018

Primary endpoint
22 September 2019

2 May 2022

Quick facts

Lead sponsor	Turku University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	80
Start date	1 March 2018
Primary completion	22 September 2019
Estimated completion	2 May 2022
Sites	1 location across Finland

Drugs / interventions tested

• Whole body contrast enhanced computer tomography
• 99mTC-HMDP planar bone scintigraphy (BS)
• 99mTc-HMDP single photon emission computer tomography/computer tomography
• Whole-body magnetic resonance imaging
• Fluorine-18-prostate specific membrane antigen-1007- positron emission tomography/computer tomography

Conditions studied

• High Risk Prostate Cancer — all drugs for High Risk Prostate Cancer →

Sponsor

Turku University Hospital

Who can join

18 and older, male only, with High Risk Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prostate cancer (PC) is the most common cancer among men and one quarter of diagnosed PC are metastatic at the time of diagnosis. Accurate staging is paramount as the stage is the most important factor when treatment decisions are made. The stage is also the single most important prognostic factor. Currently, traditional imaging methods for detection of PC metastasis, including bone scan (BS) and contrast enhanced whole-body computer tomography (CT), are rather inaccurate. Respectively, novel imaging techniques are evolving and novel imaging modalities are emerging in PC diagnostics and staging, but their clinical relevance is unclear and lacking prospective studies comparing traditional imaging with novel imaging.

This prospective single-institutional study compares the diagnostic accuracy of novel imaging modalities to traditional imaging modalities aiming to find the most appropriate staging modality in high-risk PC at the time of initial staging.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Prospective Comparison of ¹⁸F-prostate-specific Membrane Antigen-1007 Positron Emission Tomography Computed Tomography, Whole-body 1.5 T Magnetic Resonance Imaging with Diffusion-weighted Imaging, and Single-photon Emission Computed Tomography/Computed Tomography wit
   Anttinen M, Ettala O, Malaspina S, Jambor I, et al · · 2021 · cited 71× · PMID 32675047 · DOI 10.1016/j.euo.2020.06.012
2. Prospective comparison of ¹⁸F-PSMA-1007 PET/CT, whole-body MRI and CT in primary nodal staging of unfavourable intermediate- and high-risk prostate cancer.
   Malaspina S, Anttinen M, Taimen P, Jambor I, et al · · 2021 · cited 35× · PMID 33715033 · DOI 10.1007/s00259-021-05296-1
3. Detection of prostate cancer bone metastases with fast whole-body ^99mTc-HMDP SPECT/CT using a general-purpose CZT system.
   Arvola S, Seppänen M, Timonen KL, Rautio P, et al · · 2022 · cited 11× · PMID 36508016 · DOI 10.1186/s40658-022-00517-4
4. Comparison of reprojected bone SPECT/CT and planar bone scintigraphy for the detection of bone metastases in breast and prostate cancer.
   Arvola S, Seppänen M, Malaspina S, Mätzke S, et al · · 2022 · cited 7× · PMID 35081092 · DOI 10.1097/mnm.0000000000001536
5. European Association of Nuclear Medicine October 22 - 30, 2020 Virtual.
   · 2020 · cited 6× · PMID 32945931 · DOI 10.1007/s00259-020-04988-4
6. Prospective comparison of ¹⁸F-PSMA-1007 PET/CT and MRI with histopathology as the reference standard for intraprostatic tumour detection and T-staging of high-risk prostate cancer.
   Kivikallio A, Malaspina S, Saarinen I, Seppänen M, et al · · 2025 · cited 3× · PMID 40159542 · DOI 10.1007/s00259-025-07208-z