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[18]F-PSMA-1007 Imaging for Prostate Cancer

Phase 2

Recruiting

Led By Stella Koumna, MD

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours after [18]f-psma-1007 administration

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a nuclear medicine test to create an image of the body to detect prostate cancer cells. It has been shown to be better than conventional imaging and is being evaluated for safety and effectiveness.

Who is the study for?

Men over 18 with confirmed prostate cancer who can perform daily activities with some limitations (ECOG ≤2) are eligible. This includes those with high-risk, untreated localized cancer, intermediate risk factors, or biochemical recurrence after surgery or radiation. Participants must have recent standard imaging and be able to follow study procedures and provide consent. Exclusions include exceeding scanner weight limits, allergy to [18]F-PSMA-1007, severe claustrophobia or phobias of radiation, new therapy within 4 weeks for certain risks groups, or inability to remain still for imaging.

What is being tested?

[18]F-PSMA-1007 PET/CT or PET/MRI scans are being tested in this trial. These scans detect where PSMA-expressing cells are located in the body by using a radioactive substance that binds to prostate cancer cells. The trial aims to assess how well these scans work compared to conventional CT and bone scans in detecting metastatic prostate cancer and their impact on treatment plans.

What are the potential side effects?

Potential side effects from [18]F-PSMA-1007 may include allergic reactions for those sensitive to the compound. However, since it's primarily an imaging agent rather than a therapeutic drug, fewer side effects are expected compared to typical medication treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours after [18]f-psma-1007 administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours after [18]f-psma-1007 administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after [18]f-psma-1007 administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Questionnaire based assessment of the impact of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management plans

Secondary study objectives

The [18]F-PSMA-1007 level of avidity will be assessed in selected lesions and compared to background activity and cancer biologic markers (Gleason score)

The [18]F-PSMA-1007 level of avidity will be assessed in selected lesions and compared to background activity and cancer biologic markers (PSA value)

To confirm the diagnostic effectiveness of [18]F-PSMA-1007 PET/CT or PET/MRI in participants with known or suspected metastatic prostate cancer compared to standard of care cross-sectional imaging (CT chest, abdomen, pelvis)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18]F-PSMA-1007 PET/CT or PET/MRIExperimental Treatment1 Intervention

All participants will undergo a single \[18\]F-PSMA-1007 PET/CT or PET/MRI scan. Intravenous bolus injection of 4 MBq/kg +/- 10% of \[18\]F-PSMA-1007, up to a maximum of 400 MBq.

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