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Trial Title:
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
NCT ID:
NCT06335914
Condition:
Advanced Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Gallium 68 PSMA-11
Conditions: Keywords:
Prostate Specific Membrane Antigen
Positron Emission Tomography
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Ga 68 PSMA-11 PET
Description:
Positron emission tomography (PET) imaging using Ga68 PSMA 11 radiotracer
Arm group label:
PSMA and FDG PET Imaging
Intervention type:
Diagnostic Test
Intervention name:
18F-DCFPyL PET
Description:
Positron emission tomography (PET) imaging using 18F-DCFPyL radiotracer.
Arm group label:
PSMA and FDG PET Imaging
Intervention type:
Diagnostic Test
Intervention name:
FDG PET
Description:
Positron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose radiotracer.
Arm group label:
PSMA and FDG PET Imaging
Summary:
This study will use Prostate Specific Membrane Antigen (PSMA) and
(18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with
advanced prostate cancer to learn about tumor biology across disease stages and during
treatment. This may help with treatment selection and potential response monitoring in
the future.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male, age ≥ 18 years
- Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
- Poor risk patients with mCSPC at study enrollment
- De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen
pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI
- High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
- Willing to undergo study PET scans and remain under the care of medical oncology,
radiation oncology or urology physician at Princess Margaret Cancer Center.
- No prior PSMA or FDG PET imaging within the last 60 days at each specified time
point on study
- Patients enrolled in clinical trials are eligible if they satisfy all other criteria
of eligibility
Exclusion Criteria:
- Under a randomized-controlled trial with unknown allocation of systemic therapy
- Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams
- Unable to provide written consent by patient and their legal representatives
- In the opinion of the treating physician:
- conditions which would significantly impair the patient's ability to comply with
study procedures and follow up
- Significant uncontrolled comorbidity, which may negatively impact the safety or
interpretability of study PET imaging
- another active malignancy
- patient on dialysis
- another radioisotope or investigational systemic agent within 5 half-lives
prior to PET imaging
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Contact:
Last name:
Di (Maria) Jiang, M.D.
Phone:
416-946-4501
Phone ext:
4807
Email:
di.jiang@uhn.ca
Investigator:
Last name:
Di (Maria) Jiang, M.D.
Email:
Principal Investigator
Start date:
September 30, 2024
Completion date:
September 4, 2029
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06335914