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Diagnostic Test

18F-PSMA-1007 PET/CT Imaging for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of < 9 months
Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score > 7, serum PSA > 20 µg/L, OR minimum clinical T-stage T2c.
Must not have
Unable to lie flat for 30 minutes to complete the PET-CT imaging session
Weight >225 kg (weight limitation of PET/CT scanner)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately (within 15 minutes) after 18f-psma-1007 injection
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a special scan to detect prostate cancer cells in adults who have been treated for prostate cancer or are at high risk of it spreading. The scan works by using a radioactive substance that highlights cancer cells, making them visible on the scan.

Who is the study for?
This trial is for adult men with prostate cancer who've had treatments like radiotherapy or surgery, and now have rising PSA levels or high-risk features. They must be able to consent, lie flat for the scan, and not exceed the PET/CT scanner's weight limit.
What is being tested?
The study tests a new imaging method using 18F-PSMA-1007 PET/CT scans in patients with recurrent or high-risk prostate cancer. It aims to evaluate safety, how the body processes it, its effectiveness in detecting cancer compared to standard bone and CT scans.
What are the potential side effects?
Potential side effects may include allergic reactions specific to the imaging agent used (18F-PSMA-1007). However, since this is an imaging study rather than a drug treatment trial, fewer side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult who has had prostate cancer treatment and my PSA is rising or doubling quickly.
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I am an adult with prostate cancer, high Gleason score, PSA > 20, or T-stage T2c or higher.
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I am over 18, had prostate surgery, and my PSA level is above 0.2 µg/L.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot lie flat for 30 minutes.
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My weight is under 225 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately (within 15 minutes) after 18f-psma-1007 injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately (within 15 minutes) after 18f-psma-1007 injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biodistribution
Diagnostic Accuracy
Safety - delayed
+2 more
Secondary study objectives
Clinical Efficacy

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: 18F-PSMA-1007 PET/CT scanExperimental Treatment1 Intervention
Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-PSMA-1007
2022
Completed Phase 2
~200

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often target specific mechanisms to inhibit cancer growth and spread. One common approach involves targeting the prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. Radiotracers like 18F-PSMA-1007 bind to PSMA, allowing for enhanced imaging and precise localization of cancerous tissues. This aids in accurate diagnosis and staging, which is crucial for effective treatment planning. Additionally, treatments such as androgen deprivation therapy (ADT) reduce levels of male hormones that fuel cancer growth, while newer agents like enzalutamide block androgen receptors directly. These targeted therapies are essential as they offer more personalized and effective treatment options, improving outcomes and quality of life for prostate cancer patients.
Resistance to prostate cancer treatments.Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups.Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,309 Total Patients Enrolled
10 Trials studying Prostate Cancer
5,514 Patients Enrolled for Prostate Cancer

Media Library

18F-PSMA-1007 (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04733768 — Phase 2
Prostate Cancer Research Study Groups: 18F-PSMA-1007 PET/CT scan
Prostate Cancer Clinical Trial 2023: 18F-PSMA-1007 Highlights & Side Effects. Trial Name: NCT04733768 — Phase 2
18F-PSMA-1007 (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04733768 — Phase 2
~24 spots leftby Dec 2025