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Completed

NCT Number: NCT04703543

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

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Regina Elena National Cancer Institute

Rome, 00144, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pilot evaluation study on use PSMA and Cu-PET/CT

Device

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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2021
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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