Recruiting NCT06335914
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ga 68 PSMA-11 PET, 18F-DCFPyL PET, FDG PET.
- Who it may be relevant to
- Registry conditions: Advanced Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Diagnostic test Ga 68 PSMA-11 PET
Positron emission tomography (PET) imaging using Ga68 PSMA 11 radiotracer - Diagnostic test 18F-DCFPyL PET
Positron emission tomography (PET) imaging using 18F-DCFPyL radiotracer. - Diagnostic test FDG PET
Positron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose radiotracer.
Primary outcome measures
- Proportion of patients with high volume mCSPC having PSMA avid disease [Time frame: 5 years]
Secondary outcome measures (1)
- Proportion of patients with PSMA-/FDG+ discordant lesions [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT06335914 · dualPET-mPC · CAPCR: 23-5595