Status:
COMPLETED
Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Lead Sponsor:
Regina Elena Cancer Institute
Conditions:
Prostate Neoplasms
Eligibility:
MALE
18-90 years
Phase:
NA
Brief Summary
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 metho...
Detailed Description
PET/TC is a diagnostic tool potentially able to detect, in a single session, both local and distant disease. However, the sensitivity of 18-F-PET/CT in the identification of relapse on the prostatic b...
Eligibility 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
- 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
Key Trial Info
Start Date :
June 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04703543
Start Date
June 22 2017
End Date
June 9 2020
Last Update
January 11 2021
Active Locations (1)
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1
Regina Elena National Cancer Institute
Rome, Italy, 00144