Clinical trial · Interventional
18F-PSMA-1007 PET Imaging to Detect Primary Prostate Cancer
18F-PSMA-1007 PET to Detect Primary Prostate Cancer: a Comparative Study With mpMRI and Correlation to Histopathology
NCT04487847CI-TRIAL-00084801PICturecompletedPhase 1 / Phase 2ClinicalTrials.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)
To study the added value of 18F-PSMA-1007 PET to mpMRI in the detection of local prostate cancer lesions.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA-1007 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- PIRADS 1-2
- description
- 25 patients with PIRADS 1-2 (probably benign) on mpMRI
- interventionNames
- Diagnostic Test: 18F-PSMA-1007 PET/CT
- type
- EXPERIMENTAL
- label
- PIRADS 3
- description
- 25 patients with PIRADS 3 (equivocal scan) on mpMRI
- interventionNames
- Diagnostic Test: 18F-PSMA-1007 PET/CT
- type
- EXPERIMENTAL
- label
- PIRADS 4-5
- description
- 25 patients with PIRADS 4-5 (probably malignant) on mpMRI
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination) * Males ≥ 18 years * ECOG 0-1 * Signed informed consent Exclusion Criteria: * Prostate biopsy in the last 6 months * History of prostate cancer * Second active malignancy * Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip replacement surgery) * Any medical condition that in the opinion of the investigator will affect patients' clinical status when participating in this trial. * Contra-indications for mpMRI or PET: claustrophobia or inability to lay still for the duration of the exam.
References
Publications (5)
- BACKGROUNDWoo S, Suh CH, Kim SY, Cho JY, Kim SH. Diagnostic Performance of Prostate Imaging Reporting and Data System Version 2 for Detection of Prostate Cancer: A Systematic Review and Diagnostic Meta-analysis. Eur Urol. 2017 Aug;72(2):177-188. doi: 10.1016/j.eururo.2017.01.042. Epub 2017 Feb 11. PMID 28196723
- RESULTBarentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8. No abstract available. PMID 26361169
- RESULTde Rooij M, Hamoen EH, Witjes JA, Barentsz JO, Rovers MM. Accuracy of Magnetic Resonance Imaging for Local Staging of Prostate Cancer: A Diagnostic Meta-analysis. Eur Urol. 2016 Aug;70(2):233-45. doi: 10.1016/j.eururo.2015.07.029. Epub 2015 Jul 26. PMID 26215604
- RESULTvan der Leest M, Cornel E, Israel B, Hendriks R, Padhani AR, Hoogenboom M, Zamecnik P, Bakker D, Setiasti AY, Veltman J, van den Hout H, van der Lelij H, van Oort I, Klaver S, Debruyne F, Sedelaar M, Hannink G, Rovers M, Hulsbergen-van de Kaa C, Barentsz JO. Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naive Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study. Eur Urol. 2019 Apr;75(4):570-578. doi: 10.1016/j.eururo.2018.11.023. Epub 2018 Nov 23. PMID 30477981
- DERIVEDPrive BM, Israel B, Schilham MGM, Muselaers CHJ, Zamecnik P, Mulders PFA, Witjes JA, Sedelaar M, Mehra N, Verzijlbergen F, Janssen MJR, Gotthardt M, Barentsz JO, van Oort IM, Nagarajah J. Evaluating F-18-PSMA-1007-PET in primary prostate cancer and comparing it to multi-parametric MRI and histopathology. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):423-430. doi: 10.1038/s41391-020-00292-2. Epub 2020 Sep 30. PMID 32999466