Advanced Prostate Cancer
Conditions
Keywords
Prostate Specific Membrane Antigen, Positron Emission Tomography
Brief 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.
Interventions
DIAGNOSTIC_TESTGa 68 PSMA-11 PET
Positron emission tomography (PET) imaging using Ga68 PSMA 11 radiotracer
DIAGNOSTIC_TEST18F-DCFPyL PET
Positron emission tomography (PET) imaging using 18F-DCFPyL radiotracer.
DIAGNOSTIC_TESTFDG PET
Positron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose radiotracer.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with high volume mCSPC having PSMA avid disease | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with PSMA-/FDG+ discordant lesions | 5 years |
Countries
Canada
Contacts
CONTACTDi (Maria) Jiang, M.D.
PRINCIPAL_INVESTIGATORDi (Maria) Jiang
Princess Margaret Cancer Centre/University Health Network
Outcome results
None listed