Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Primary Purpose
Prostate Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pilot evaluation study on use PSMA and Cu-PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Neoplasms focused on measuring PET-CT Scan, mpMRI, prostate neoplasms
Eligibility 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
Sites / Locations
- Regina Elena National Cancer Institute
Outcomes
Primary Outcome Measures
To calculate the detection rate of PSMA and Cu-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence
Ratio between positive PSMA and Cu-PET/CT patients and the total of enrolled patients (positive MRI)
Secondary Outcome Measures
Full Information
NCT ID
NCT04703543
First Posted
July 15, 2020
Last Updated
January 8, 2021
Sponsor
Regina Elena Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04703543
Brief Title
Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Official Title
Pilot Study Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
June 9, 2020 (Actual)
Study Completion Date
June 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Neoplasms
Keywords
PET-CT Scan, mpMRI, prostate neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients with metastatic prostatic cancer
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pilot evaluation study on use PSMA and Cu-PET/CT
Intervention Description
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
Primary Outcome Measure Information:
Title
To calculate the detection rate of PSMA and Cu-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence
Description
Ratio between positive PSMA and Cu-PET/CT patients and the total of enrolled patients (positive MRI)
Time Frame
60 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
prostatic neoplasm
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Regina Elena National Cancer Institute
City
Rome
ZIP/Postal Code
00144
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
35516461
Citation
Bottero 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.
Results Reference
derived
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Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
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