Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer

• ClinicalTrials.gov Identifier: NCT04703543
• Recruitment Status: Completed
• First Posted: January 11, 2021
• Last Update Posted: January 11, 2021
• Sponsor: Regina Elena Cancer Institute
• Information provided by (Responsible Party): Giuseppe Sanguineti, Regina Elena Cancer Institute

Tracking Information

• First Submitted Date: July 15, 2020
• First Posted Date: January 11, 2021
• Last Update Posted Date: January 11, 2021
• Actual Study Start Date: June 22, 2017
• Actual Primary Completion Date: June 9, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 8, 2021)

To calculate the detection rate of PSMA and Cu-PET/CT of relapses in patients undergoing radical prostatectomy and subsequent biochemical recurrence [ Time Frame: 60 months ]

Ratio between positive PSMA and Cu-PET/CT patients and the total of enrolled patients (positive MRI)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

patients with metastatic prostatic cancer

Masking: None (Open Label)
Primary Purpose: Diagnostic

• Condition: Prostate Neoplasms

Intervention

Device: Pilot 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

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 8, 2021): 50
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 9, 2020
• Actual Primary Completion Date: June 9, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: prostatic neoplasm

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04703543
• Other Study ID Numbers: RS946/17(1974)
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Giuseppe Sanguineti, Regina Elena Cancer Institute
• Study Sponsor: Regina Elena Cancer Institute
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Regina Elena Cancer Institute
• Verification Date: January 2021