NCT06335914

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
41mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Apr 2025Sep 2029

First Submitted

Initial submission to the registry

March 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

April 3, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2029

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

March 21, 2024

Last Update Submit

February 9, 2026

Conditions

Advanced Prostate Cancer

Keywords

Prostate Specific Membrane AntigenPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with high volume mCSPC having PSMA avid disease

    5 years

Secondary Outcomes (1)

  • Proportion of patients with PSMA-/FDG+ discordant lesions

    5 years

Study Arms (1)

PSMA and FDG PET Imaging

EXPERIMENTAL

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

Diagnostic Test: Ga 68 PSMA-11 PETDiagnostic Test: 18F-DCFPyL PETDiagnostic Test: FDG PET

Interventions

Ga 68 PSMA-11 PETDIAGNOSTIC_TEST

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

PSMA and FDG PET Imaging
18F-DCFPyL PETDIAGNOSTIC_TEST

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

PSMA and FDG PET Imaging
FDG PETDIAGNOSTIC_TEST

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

PSMA and FDG PET Imaging

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Study Officials

  • Di (Maria) Jiang

    Princess Margaret Cancer Centre/University Health Network

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Di (Maria) Jiang, M.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 28, 2024

Study Start

April 3, 2025

Primary Completion (Estimated)

March 4, 2029

Study Completion (Estimated)

September 4, 2029

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)