Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer

February 11, 2020 updated by: Gad Abikhzer, Jewish General Hospital

Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Studies have shown that PSMA PET/CT can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low. PSMA imaging is considered the gold standard in imaging of biochemical recurrence, with detection rate of recurrence in 79.5% of patients, in the largest series of 1007 patients. Despite these excellent results, there remains approximately 20% of patients in whom the site of biochemical recurrence cannot be identified and further research is needed into improving detection rates.

Androgen deprivation therapy (ADT), represents the standard of care treatment for most men with a rising serum PSA and no evidence of disseminated disease on imaging modalities. There has been some preliminary data that imaging patients early after initiation of ADT therapy may increase detection rates of recurrence sites.

The objective of this study is to evaluate if prostate cancer patients with biochemical recurrence and negative PSMA PET/CT can demonstrate in-vivo upregulation of PSMA receptors in an attempt to improve detection rates of recurrent prostate cancer. Patients who are started on ADT when clinically indicated, will have repeat PSMA PET/CT at 4 weeks following initiation of ADT therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

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

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4R3E8
        • Jewish General Hospital

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male sex
  • Age 18 years or older
  • Previous diagnosis of prostate cancer following radical prostatectomy or primary radiation therapy, with biochemical recurrence.
  • Prior negative PSMA PET/CT within 2 months prior to study entry
  • ECOG performance status 0 - 3, inclusive
  • Able to understand and provide written informed consent
  • Initiation of androgen deprivation therapy within 5 weeks prior to study PSMA PET/CT
  • Able to tolerate the physical/logistical requirements of a PET/CT scan

Exclusion Criteria

  • Medically unstable patients
  • Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
  • Patients with unmanageable claustrophobia

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
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PSMA PET/CT
Repeat PSMA PET/CT after ADT
Diagnostic test: PSMA PET/CT
Repeat PSMA PET/CT 4 weeks post initiation of clinically indicated ADT in patients with prior negative PSMA PET/CT performed for biochemical recurrence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rates of recurrence
Time Frame: 2 years
The percentage of 18F-DCFPyL PET/CT positive for identification of biochemical recurrence sites in patients with prostate cancer following initiation of ADT therapy.
2 years

Collaborators and Investigators

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

Sponsor

Jewish General Hospital

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)

February 2, 2018

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

May 2, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CODIM-MDM-18-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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