Clinical trial · Interventional
Novel Imaging in Staging of Primary Prostate Cancer
Imaging for Prostate Cancer Metastasis Detection - Traditional Imaging (Bone Scan and CT) Versus PSMA-PET-CT, SPECT-CT and Whole-Body MRI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTC-HMDP planar bone scintigraphy (BS) | Diagnostic Test | — | UNRESOLVED |
| 99mTc-HMDP single photon emission computer tomography/computer tomography | Diagnostic Test | — | UNRESOLVED |
| Fluorine-18-prostate specific membrane antigen-1007- positron emission tomography/computer tomography | Diagnostic Test | — | UNRESOLVED |
| Whole body contrast enhanced computer tomography | Diagnostic Test | — | UNRESOLVED |
| Whole-body magnetic resonance imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging based staging of high risk PC
- description
- Each individual study patient will be imaged for PC metastasis detection with each different imaging modalities as follows: Traditional imaging (clinical standard imaging); 1. Whole-body contrast enhanced computer tomography 2. Planar bone scintigraphy Novel imaging (investigational imaging); 3. SPECT/CT (investigational imaging) 4. 18F-PSMA-PET/CT (investigational imaging) 5. Whole-body MRI (investigational imaging) In order to define the true nature of the findings from each different imaging modality, comparison with best valuable comparator (BvC) is made. Consensus reading of all imaging modalities and follow-up data of clinical, imaging, histopathological and laboratory results are used to define BvC.
- interventionNames
- Diagnostic Test: Whole body contrast enhanced computer tomography
- Diagnostic Test: 99mTC-HMDP planar bone scintigraphy (BS)
- Diagnostic Test: 99mTc-HMDP single photon emission computer tomography/computer tomography
- Diagnostic Test: Whole-body magnetic resonance imaging
- Diagnostic Test: Fluorine-18-prostate specific membrane antigen-1007- positron emission tomography/computer tomography
Primary outcomes (1)
- measure
- To compare the diagnostic accuracy of 18F-PSMA-1007-PET/CT (PSMA-PET/CT) to 99mTc-HMDP planar bone scintigraphy (planar BS) in pessimistic, patient-based analysis detecting of bone metastases in the initial staging of high-risk PC patients.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed PC without previous PC treatment * High-risk PC defined with one or more of the following criteria: Gleason ≥4+3, PSA ≥20, cT≥3a * Adequate physical status defined (by treating clinician) as capability to undergo some form of active treatment for the PC and the physical status allowing the patient to undergo all study imaging modalities * Signed informed consent Exclusion Criteria: * Previous PC treatment. Short-term androgen deprivation therapy is permitted if necessary for symptomatic and/or very high-risk PC patients * Contraindications for MRI (cardiac pacemaker, intracranial clips etc.) * Claustrophobia
References
Publications (34)
- BACKGROUNDSeikkula HA, Kaipia AJ, Rantanen ME, Pitkaniemi JM, Malila NK, Bostrom PJ. Stage-specific mortality and survival trends of prostate cancer patients in Finland before and after introduction of PSA. Acta Oncol. 2017 Jul;56(7):971-977. doi: 10.1080/0284186X.2017.1288298. Epub 2017 Feb 13. PMID 28406044
- BACKGROUNDHeidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6. PMID 24207135
- BACKGROUNDSuh CH, Shinagare AB, Westenfield AM, Ramaiya NH, Van den Abbeele AD, Kim KW. Yield of bone scintigraphy for the detection of metastatic disease in treatment-naive prostate cancer: a systematic review and meta-analysis. Clin Radiol. 2018 Feb;73(2):158-167. doi: 10.1016/j.crad.2017.08.004. Epub 2017 Sep 25. PMID 28958581
- BACKGROUNDEven-Sapir E. Imaging of malignant bone involvement by morphologic, scintigraphic, and hybrid modalities. J Nucl Med. 2005 Aug;46(8):1356-67. PMID 16085595
- BACKGROUNDVan den Wyngaert T, Strobel K, Kampen WU, Kuwert T, van der Bruggen W, Mohan HK, Gnanasegaran G, Delgado-Bolton R, Weber WA, Beheshti M, Langsteger W, Giammarile F, Mottaghy FM, Paycha F; EANM Bone & Joint Committee and the Oncology Committee. The EANM practice guidelines for bone scintigraphy. Eur J Nucl Med Mol Imaging. 2016 Aug;43(9):1723-38. doi: 10.1007/s00259-016-3415-4. Epub 2016 Jun 4. PMID 27262701
- BACKGROUNDEven-Sapir E, Metser U, Mishani E, Lievshitz G, Lerman H, Leibovitch I. The detection of bone metastases in patients with high-risk prostate cancer: 99mTc-MDP Planar bone scintigraphy, single- and multi-field-of-view SPECT, 18F-fluoride PET, and 18F-fluoride PET/CT. J Nucl Med. 2006 Feb;47(2):287-97.