Clinical trial · Interventional
High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
NCT03327675CI-TRIAL-00078544unknownN/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)
This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.
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 |
|---|---|---|---|
| 68Ga-PSMA (HBED-CC) PET | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA PET/MR
- description
- Hybrid 68Ga-PSMA PET/MR scan
- interventionNames
- Other: 68Ga-PSMA (HBED-CC) PET
Primary outcomes (1)
- measure
- 68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.
- timeFrame
- through study completion, an average of 2 year
- description
- Assessment of the sensitivity, specificity, positive and negative predictive
Secondary outcomes (3)
- measure
- The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria Work-unit 1 * age \< 75 years of age, with histologically proven invasive adenocarcinoma of the prostate * a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1) * scheduled to undergo radical prostatectomy with extended lymph node dissection Work-unit 2 * histologically proven diagnosis of prostate cancer * biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment * WHO performance state 0-1 * age \> 18 years old Exclusion criteria Work-unit 1 * involvement of pelvic lymph nodes assessed by multi-parametric MRI * evidence for bone metastasis assessed by bone scan (if PSA \> 20 ng/ml) * WHO performance status \> 2 * previous pelvic irradiation or radical prostatectomy. * other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Work-unit 2 * serum testosterone level \<50ng/ml * symptomatic metastases * local relapse on MRI * PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy * previous treatment with cytotoxic agent for PCa * treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…) * disorder precluding understanding of trial information or informed consent
References
Publications (2)
- DERIVEDAhmadi Bidakhvidi N, Lara Jimenez E, Leupe H, Jentjens S, Baldewijns M, De Schepper M, Laenen A, Devos G, Giesen A, Koole M, Deroose CM, Everaerts W, Joniau S, Goffin K. Interreader agreement of intraprostatic prostate cancer detection, local extension and staging using [18F]PSMA-1007 PET and whole-mount radical prostatectomy specimens. EJNMMI Res. 2026 Jan 9;16(1):11. doi: 10.1186/s13550-025-01359-8. PMID 41511587
- DERIVEDDraulans C, De Roover R, van der Heide UA, Kerkmeijer L, Smeenk RJ, Pos F, Vogel WV, Nagarajah J, Janssen M, Isebaert S, Maes F, Mai C, Oyen R, Joniau S, Kunze-Busch M, Goffin K, Haustermans K. Optimal 68Ga-PSMA and 18F-PSMA PET window levelling for gross tumour volume delineation in primary prostate cancer. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1211-1218. doi: 10.1007/s00259-020-05059-4. Epub 2020 Oct 6. PMID 33025093