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

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

Condition or disease Intervention/treatment Phase
Prostate Neoplasms Device: Pilot evaluation study on use PSMA and Cu-PET/CT Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: patients with metastatic prostatic cancer
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : June 9, 2020
Actual Study Completion Date : June 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   prostatic neoplasm
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04703543


Locations
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Italy
Regina Elena National Cancer Institute
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
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Responsible Party: Giuseppe Sanguineti, Professor, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT04703543    
Other Study ID Numbers: RS946/17(1974)
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe Sanguineti, Regina Elena Cancer Institute:
PET-CT Scan
mpMRI
prostate neoplasms
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases