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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 15, 2020
First Posted Date  ICMJE January 11, 2021
Last Update Posted Date January 11, 2021
Actual Study Start Date  ICMJE June 22, 2017
Actual Primary Completion Date June 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Role of Both PSMA and 64Cu-PET/CT Total Body in Patients With Locally Relapsed Prostate Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
patients with metastatic prostatic cancer
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Neoplasms
Intervention  ICMJE 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  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2021)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 9, 2020
Actual Primary Completion Date June 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: prostatic neoplasm
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04703543
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Giuseppe Sanguineti, Regina Elena Cancer Institute
Study Sponsor  ICMJE Regina Elena Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Regina Elena Cancer Institute
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP