Clinical trial · Interventional
Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Pilot Study Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
NCT04703543CI-TRIAL-00049339completedN/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)
The purpose of this study is to assess the detection rate of local relapse after radical prostatectomy with either PSMA or 64Cu-PET/CTs and whether the delineation of relapsed lesions using both methods can facilitate/change the therapeutic strategy of the radiation oncologist
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 Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pilot evaluation study on use PSMA and Cu-PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To calculate the detection rate of PSMA and Cu-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence
- timeFrame
- 60 months
- description
- Ratio between positive PSMA and Cu-PET/CT patients and the total of enrolled patients (positive MRI)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Criteria: Inclusion Criteria: * Localized prostate adenocarcinoma (M0), any PSA value, any Gleason Score * Previous radical surgery with subsequent undetectable PSA (\<0.2 ng/ml) * Biochemical recurrence (two consecutive PSA values of at least 0.2 ng/ml) * M0 to 18F-choline PET/TC * Local relapse at mpMR * Age\>18 years * Performance Status 0-1 according to ECOG * Informed written consent Exclusion Criteria: * Detectable PSA after surgery * Secondary bone lesions from prostate cancer or M1 * Hormone therapy started before staging examinations * Previous pelvic radiotherapy * Crohn's disease or ulcerative colitis (active phase) * Psychiatric diseases * Contraindication to MRI (metal prostheses, pacemakers, claustrophobia, etc.) * Presence of coxo-femoral implants
References
Publications (1)
- DERIVEDBottero M, Faiella A, Giannarelli D, Farneti A, D'Urso P, Bertini L, Landoni V, Vici P, Sanguineti G. A prospective study assessing the pattern of response of local disease at DCE-MRI after salvage radiotherapy for prostate cancer. Clin Transl Radiat Oncol. 2022 Apr 27;35:21-26. doi: 10.1016/j.ctro.2022.04.010. eCollection 2022 Jul. PMID 35516461