PSMA and FDG PET imaging for advanced prostate cancer
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
This trial will test whether combining PSMA and FDG PET scans can better show tumor biology and help guide treatment for men with advanced prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06335914 on ClinicalTrials.gov |
What this trial studies
This single-center study at Princess Margaret Cancer Centre will use two molecular PET scans—PSMA PET (Ga-68 PSMA-11 or 18F-DCFPyL) and FDG PET—to image men with advanced prostate cancer at defined disease stages and during treatment. Eligible participants include men with de novo or recurrent high-volume metastatic castration-sensitive prostate cancer or those with PSA ≥4.0 after 6–8 months of ADT. Participants will undergo both tracers with imaging schedules that avoid prior PSMA/FDG PET within 60 days of each time point to enable direct comparison. Imaging findings will be correlated with clinical status to see if combined PET signatures can inform treatment selection and monitor response.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed prostate adenocarcinoma who have high-volume or de novo metastatic castration-sensitive disease, or PSA ≥4.0 after 6–8 months of ADT, and who can undergo PET imaging and follow-up care at Princess Margaret are ideal candidates.
Not a fit: Patients whose tumors lack PSMA expression, those with very poor performance status or limited life expectancy, or those unable to undergo PET imaging may not gain useful information from these scans.
Why it matters
Potential benefit: If successful, combining PSMA and FDG PET could improve therapy selection and earlier detection of treatment-resistant disease by revealing complementary tumor biology.
How similar studies have performed: PSMA PET is well established and diagnostically valuable in prostate cancer, while combining PSMA and FDG PET is a newer approach with promising but still limited supporting data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Di (Maria) Jiang — Princess Margaret Cancer Centre/University Health Network
- Study coordinator: Di (Maria) Jiang, M.D.
- Email: di.jiang@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.