Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer

Advanced Prostate Cancer Clinical Trial

Official title:

Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335914
• Other study ID #: dualPET-mPC
• Secondary ID: CAPCR: 23-5595
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 4, 2029

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: Di (Maria) Jiang, M.D.
• Phone: 416-946-4501
• Email: di.jiang[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 4, 2029
• Est. primary completion date: March 4, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with high volume mCSPC having PSMA avid disease		5 years
Secondary	Proportion of patients with PSMA-/FDG+ discordant lesions		5 years