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

Prostate Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703543
• Other study ID #: RS946/17(1974)
• Status: Completed
• Phase: N/A
• Start date: June 22, 2017
• Est. completion date: June 9, 2020

Study information

• Verified date: January 2021
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 9, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Neoplasms
• Prostatic 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

Locations

Country	Name	City	State
Italy	Regina Elena National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	60 months