Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PSMA PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility 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
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PSMA PET/CT
Arm Description
Repeat PSMA PET/CT after ADT
Outcomes
Primary Outcome Measures
Detection rates of recurrence
The percentage of 18F-DCFPyL PET/CT positive for identification of biochemical recurrence sites in patients with prostate cancer following initiation of ADT therapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03938766
Brief Title
Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer
Official Title
Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSMA PET/CT
Arm Type
Other
Arm Description
Repeat PSMA PET/CT after ADT
Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA PET/CT
Intervention Description
Repeat PSMA PET/CT 4 weeks post initiation of clinically indicated ADT in patients with prior negative PSMA PET/CT performed for biochemical recurrence.
Primary Outcome Measure Information:
Title
Detection rates of recurrence
Description
The percentage of 18F-DCFPyL PET/CT positive for identification of biochemical recurrence sites in patients with prostate cancer following initiation of ADT therapy.
Time Frame
2 years
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4R3E8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer
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