Recruiting

PSMA & FDG PET

Sponsor:

University Health Network, Toronto

Code:

NCT06335914

Conditions

Advanced Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ga 68 PSMA-11 PET

18F-DCFPyL PET

FDG PET

Study Details

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.

Conditions

Advanced Prostate Cancer

Study ID

NCT06335914

Start date

Apr 3, 2025

Status verified date

Feb, 2026

Completion date

Sep 4, 2029

Anticipated

Primary completion date

Mar 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: PSMA and FDG PET Imaging

Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.

Interventions

Ga 68 PSMA-11 PET

Positron emission tomography (PET) imaging using Ga68 PSMA 11 radiotracer

18F-DCFPyL PET

Positron emission tomography (PET) imaging using 18F-DCFPyL radiotracer.

FDG PET

Positron emission tomography (PET) imaging using (18) F-fluorodeoxyglucose radiotracer.

Primary outcome measure

  • Proportion of patients with high volume mCSPC having PSMA avid disease [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Di (Maria) Jiang, M.D.

416-946-4501di.jiang@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Di (Maria) Jiang, M.D.

416-946-4501di.jiang@uhn.ca

Principal Investigator:

Di (Maria) Jiang, M.D.

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Prostate Specific Membrane Antigen
  • Positron Emission Tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-02-12.