Clinical trial · Interventional
A Study of 68Ga-GRP PET/CT for Imaging in Low and Intermediate Risk Prostate Cancer
NCT05073653CI-TRIAL-00054548unknownN/AClinicalTrials.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)
Patients with primary low and intermediate risk prostate cancer (PCa) for whom radical prostatectomy are indicated, will be invited to participate to the present study. The aim of this study is to investigate the clinical value of 68Ga-GRP positron emission tomography / computed tomography (PET/CT) compared to 68Ga-PSMA PET/CT in patients with low and intermediate risk PCa.
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-GRP PET/CT | Diagnostic Test | — | UNRESOLVED |
| 68Ga-PSMA PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- 68Ga-PSMA PET/CT Imaging
- description
- Injection of the radioligand 68Ga-PSMA; Device: PET/CT; Following injection of 68Ga-PSMA, the participants will be subjected to whole body PET/CT.
- interventionNames
- Diagnostic Test: 68Ga-PSMA PET/CT
- type
- OTHER
- label
- 68Ga-GRP PET/CT Imaging
- description
- Injection of the radioligand 68Ga-GRP; Device: PET/CT; Following injection of 68Ga-GRP, the participants will be subjected to whole body PET/CT.
- interventionNames
- Diagnostic Test: 68Ga-GRP PET/CT
Primary outcomes (2)
- measure
- Median Standardized Uptake Value (SUV)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * patients divided in : * Patients with low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value \< 10 ng/mL); * Patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10-20 ng/mL); * Patients with high risk prostate cancer (Gleason \> 7 or cT2c or PSA value \> 20 ng/mL); * Candidate for radical prostatectomy after discussion in multidisciplinary committee; * Written informed consent willingly obtained. Exclusion Criteria: * Any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…); * Patient not candidate for radical prostatectomy and/or unable to benefit from surgery; * Patient under legal protection or unable to express its own consent; * Patient within exclusion period from another clinical trial; * Claustrophobia (unable to accept PET/CT scanning).
References
Publications (8)
- RESULTSiegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. PMID 33433946
- RESULTFenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-Specific Antigen-Based Screening for Prostate Cancer: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 May 8;319(18):1914-1931. doi: 10.1001/jama.2018.3712. PMID 29801018
- RESULTPerera M, Papa N, Roberts M, Williams M, Udovicich C, Vela I, Christidis D, Bolton D, Hofman MS, Lawrentschuk N, Murphy DG. Gallium-68 Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer-Updated Diagnostic Utility, Sensitivity, Specificity, and Distribution of Prostate-specific Membrane Antigen-avid Lesions: A Systematic Review and Meta-analysis. Eur Urol. 2020 Apr;77(4):403-417. doi: 10.1016/j.eururo.2019.01.049. Epub 2019 Feb 14. PMID 30773328
- RESULTMansi R, Fleischmann A, Macke HR, Reubi JC. Targeting GRPR in urological cancers--from basic research to clinical application. Nat Rev Urol. 2013 Apr;10(4):235-44. doi: 10.1038/nrurol.2013.42. Epub 2013 Mar 19. PMID 23507930
- RESULTWieser G, Mansi R, Grosu AL, Schultze-Seemann W, Dumont-Walter RA, Meyer PT, Maecke HR, Reubi JC, Weber WA. Positron emission tomography (PET) imaging of prostate cancer with a gastrin releasing peptide receptor antagonist--from mice to men. Theranostics. 2014 Feb 1;4(4):412-9. doi: 10.7150/thno.7324. eCollection 2014. PMID 24578724
- RESULTZhang J, Niu G, Fan X, Lang L, Hou G, Chen L, Wu H, Zhu Z, Li F, Chen X. PET Using a GRPR Antagonist 68Ga-RM26 in Healthy Volunteers and Prostate Cancer Patients. J Nucl Med. 2018 Jun;59(6):922-928. doi: 10.2967/jnumed.117.198929. Epub 2017 Nov 9. PMID 29123014
- RESULTTouijer KA, Michaud L, Alvarez HAV, Gopalan A, Kossatz S, Gonen M, Beattie B, Sandler I, Lyaschenko S, Eastham JA, Scardino PT, Hricak H, Weber WA. Prospective Study of the Radiolabeled GRPR Antagonist BAY86-7548 for Positron Emission Tomography/Computed Tomography Imaging of Newly Diagnosed Prostate Cancer. Eur Urol Oncol. 2019 Mar;2(2):166-173. doi: 10.1016/j.euo.2018.08.011. Epub 2018 Sep 22.