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

January 8, 2021 updated by: Giuseppe Sanguineti, Regina Elena Cancer Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00144
        • Regina Elena National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 22, 2017

Primary Completion (ACTUAL)

June 9, 2020

Study Completion (ACTUAL)

June 9, 2020

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

January 8, 2021

First Posted (ACTUAL)

January 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS946/17(1974)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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