Prostate Neoplasms
Conditions
Keywords
PET-CT Scan, mpMRI, prostate neoplasms
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 methods can facilitate/change the therapeutic strategy of the radiation oncologist
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 bed, varies greatly and depends on the value of PSA with which the examination is carried out, the size of the relapse in the lodge, the acquisition protocol and it is limited by the physiological hyperaccumulation of the tracer in the bladder. The sensitivity of 18F-Choline PET/TC in our hands is significantly higher than the one that is generally reported in the literature (76% with PSA values \>1 ng/ml after radical prostatectomy), but still lower than the one of mpMR. PET/CT with 64Cu exceeds the limits of 18F-choline PET/TC in the study of the prostatic bed, as the tracer used (64Cu) is not excreted by urinary route and therefore does not accumulate in the bladder. This study has the following objectives: Primary objective: - To evaluate the detection rate of both 64Cu-PET/CT and PSMA-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence; Secondary objectives are: * to assess any change in radiation therapy strategy in terms of lesion delineation and dose distribution at planning. * to evaluate the performance of both methods (mpMR and PSMA/64Cu-PET/CT) in assessing the response to radiotherapy with or without androgen deprivation
Interventions
DEVICEPilot evaluation study on use PSMA and Cu-PET/CT
This study aims at assessing the detection rate of both PSMA and Cu-PET/CT on tissue relapse, study whether this method is equivalent to mpMR
Sponsors
Regina Elena Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
patients with metastatic prostatic cancer
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To calculate the detection rate of PSMA and Cu-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence | 60 months | Ratio between positive PSMA and Cu-PET/CT patients and the total of enrolled patients (positive MRI) |
Countries
Italy
Outcome results
None listed