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Clinical Trial · NCT06335914
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
Overview
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.
Sponsor
University Health Network, Toronto
Phase
N/A
Contacts
Di (Maria) Jiang, M.D. (CONTACT)
di.jiang@uhn.ca
416-946-4501
Di (Maria) Jiang (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT06335914Drug / Compound
FDG
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
Eligibility
Inclusion
- Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
- Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center.
- 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
- Patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility
- High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
- No prior PSMA or FDG PET imaging within the last 60 days at each specified time point on study
Exclusion
- Unable to provide written consent by patient and their legal representatives
- conditions which would significantly impair the patient's ability to comply with study procedures and follow up
- In the opinion of the treating physician:
- Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging
- patient on dialysis
- Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams
- another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging
- Under a randomized-controlled trial with unknown allocation of systemic therapy
- another active malignancy
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