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

NCT ID: NCT06335914

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2029-09-04

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ga 68 PSMA-11 PET

Intervention Type DIAGNOSTIC_TEST

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

18F-DCFPyL PET

Intervention Type DIAGNOSTIC_TEST

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

FDG PET

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Ga 68 PSMA-11 PET

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

Intervention Type DIAGNOSTIC_TEST

18F-DCFPyL PET

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

Intervention Type DIAGNOSTIC_TEST

FDG PET

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Di (Maria) Jiang

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre/University Health Network

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Di (Maria) Jiang, M.D.

Role: CONTACT

416-946-4501 ext. 4807

Facility Contacts

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Di (Maria) Jiang, M.D.

Role: primary

416-946-4501 ext. 4807

Other Identifiers

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CAPCR: 23-5595

Identifier Type: OTHER

Identifier Source: secondary_id

dualPET-mPC

Identifier Type: -

Identifier Source: org_study_id

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