PSMA and FDG PET imaging for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.