Clinical trial · Interventional
PET/MRI in Patients With Suspected Prostate Cancer
Randomized Assessment of Patients With Clinically Suspected Prostate Cancer After Multiparametric Metabolic Hybrid Imaging to Evaluate Its Potential Clinical Domain: A Prospective, Randomized, Multi-arm, Multi-treatment Clinical Trial
NCT02659527CI-TRIAL-00067213completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This diagnostic clinical trial will be conducted according to a randomized, prospective, controlled, double-arm, single-centre design. The control will be implemented by comparing the PET/MRI results with the histopathological finding after radical prostatectomy (positive state), the assumed absence of a relevant prostate cancer focus if PET/MRI guided biopsy and standard biopsy are negative (negative state) and/or the detection of a biochemical tumor relapse \[rising prostate specific antigen (PSA) after PSA nadir; secondary objective\].
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga- PSMA-HBED-CC | Drug | — | UNRESOLVED |
| Biograph mMR, Siemens | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- standardized needle biopsy
- description
- All enrolled patients are examined by means of dual tracer PET / MRI. Images will be interpreted by 4 designated readers. The readers are blinded of the respective results among each other. A consensus of the two principal readers of nuclear medicine and radiology will serve as reference for the guided needle biopsy. Additionally the readers are blinded to any result of the pathological workout until the recruitment of the last patient is finished. According to the randomization, the standardized 12 core TRUS (TransRectal UltraSound)-guided biopsy is performed without knowledge of imaging findings by the urologist. If the biopsy is negative patients will have an additional image-guided biopsy with 4 more cores samples. After a positive biopsy the subjects be treated according to normal clinical practice.
- interventionNames
- Drug: 68Ga- PSMA-HBED-CC
- Device: Biograph mMR, Siemens
- type
- EXPERIMENTAL
- label
- image-guided biopsy
- description
- All enrolled patients are examined by means of dual tracer PET / MRI. Images will be interpreted by 4 designated readers. The readers are blinded of the respective results among each other. A consensus of the two principal readers of nuclear medicine and radiology will serve as reference for the guided needle biopsy. Additionally the readers are blinded to any result of the pathological workout until the recruitment of the last patient is finished. Patients will have a standardized 12 core TRUS-guided biopsy without knowledge of imaging findings by the urologist. Patients randomized in this arm will have an additional image-guided biopsy with 4 more cores samples. After a positive biopsy the subjects be treated according to normal clinical practice.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * blood PSA level \> 4.0 ng/ml and * free-to-total PSA ratio \<22% and/or * progressive rise of PSA levels in two consecutive blood samples despite antibiotics Exclusion Criteria: * antiandrogen therapy * prostate needle biopsy \<21 days before PET/MRI * known active secondary cancer * endorectal coil not applicable (e.g. anus praetor with short rectal stump) * known active prostatitis (e.g. painful DRE) * known anaphylaxis against gadolinium-DOTA * patient's written informed consent not given * needle biopsy and/or prostatectomy compound not available for histology/immunohistochemistry
References
Publications (4)
- DERIVEDHartenbach M, Rasul S, Grubmuller B, Kramer G, Baltzer P, Helbich T, Eiber M, Hartenbach S, Grahovac M, Susani M, Mazal P, Wadsak W, Einspieler H, Weber M, Kenner L, Haug AR, Hacker M. PSMA-Directed PET/MRI Enables Noninvasive Diagnosis and Prognosis in Patients with Increased PSA Levels: Results from the Prospective Randomized RAPID Trial. J Nucl Med. 2026 Feb 2;67(2):224-231. doi: 10.2967/jnumed.125.270404. PMID 41266255
- DERIVEDNing J, Spielvogel CP, Haberl D, Trachtova K, Stoiber S, Rasul S, Bystry V, Wasinger G, Baltzer P, Gurnhofer E, Timelthaler G, Schlederer M, Papp L, Schachner H, Helbich T, Hartenbach M, Grubmuller B, Shariat SF, Hacker M, Haug A, Kenner L. A novel assessment of whole-mount Gleason grading in prostate cancer to identify candidates for radical prostatectomy: a machine learning-based multiomics study. Theranostics. 2024 Aug 1;14(12):4570-4581. doi: 10.7150/thno.96921. eCollection 2024. PMID 39239512
- DERIVEDPapp L, Spielvogel CP, Grubmuller B, Grahovac M, Krajnc D, Ecsedi B, Sareshgi RAM, Mohamad D, Hamboeck M, Rausch I, Mitterhauser M, Wadsak W, Haug AR, Kenner L, Mazal P, Susani M, Hartenbach S, Baltzer P, Helbich TH, Kramer G, Shariat SF, Beyer T, Hartenbach M, Hacker M. Supervised machine learning enables non-invasive lesion characterization in primary prostate cancer with [68Ga]Ga-PSMA-11 PET/MRI. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1795-1805. doi: 10.1007/s00259-020-05140-y. Epub 2020 Dec 19. PMID 33341915
- DERIVEDAksoy O, Pencik J, Hartenbach M, Moazzami AA, Schlederer M, Balber T, Varady A, Philippe C, Baltzer PA, Mazumder B, Whitchurch JB, Roberts CJ, Haitel A, Herac M, Susani M, Mitterhauser M, Marculescu R, Stangl-Kremser J, Hassler MR, Kramer G, Shariat SF, Turner SD, Tichy B, Oppelt J, Pospisilova S, Hartenbach S, Tangermann S, Egger G, Neubauer HA, Moriggl R, Culig Z, Greiner G, Hoermann G, Hacker M, Heery DM, Merkel O, Kenner L. Thyroid and androgen receptor signaling are antagonized by mu-Crystallin in prostate cancer. Int J Cancer. 2021 Feb 1;148(3):731-747. doi: 10.1002/ijc.33332. Epub 2020 Oct 31. PMID 33034050