About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03938766

Recruitment Status Completed

First Posted May 6, 2019

Last update posted February 12, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Prostate Cancer
  • Intervention/Treatment: Diagnostic Test: PSMA PET/CT
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 2 participants
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer
  • Actual Study Start Date: February 2018
  • Actual Primary Completion Date: February 2020
  • Actual Study Completion Date: February 2020
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations

Canada, Quebec
Jewish General Hospital
Montréal

Sponsors and Collaborators

Jewish General Hospital

More Information
  • Responsible Party: Jewish General Hospital
  • ClinicalTrials.gov Identifier: NCT03938766 History of Changes
  • Other Study ID Numbers: CODIM-MDM-18-001
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: February 12, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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.: Yes
  • Additional relevant MeSH terms: Prostatic Neoplasms