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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Questionnaire based assessment of the impact of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management plans
Secondary outcome measures
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 moreTrial 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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Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
35,964 Total Patients Enrolled
15 Trials studying Prostate Cancer
1,962 Patients Enrolled for Prostate Cancer
Stella Koumna, MDPrincipal InvestigatorCross Cancer Institute, Alberta Health Services
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 18 or older.I can't stay still for long periods due to a condition like severe arthritis.I can take care of myself and am up and about more than half of my waking hours.I started new treatment for my prostate cancer less than 4 weeks ago.My prostate cancer diagnosis was confirmed through tissue or cell testing.
Research Study Groups:
This trial has the following groups:- Group 1: [18]F-PSMA-1007 PET/CT or PET/MRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the combination of [18]F-PSMA-1007 PET/CT or PET/MRI permitted by regulatory bodies?
"The safety of [18]F-PSMA-1007 PET/CT or PET/MRI was rated 2 out of 3 by our team at Power because this Phase 2 trial has produced evidence in support of its security, yet no clinical data to corroborate its efficacy."
Answered by AI
Are there any vacancies for this research study at present?
"The clinicaltrial.gov website reports that this particular trial has concluded its patient recruitment phase, as the posting dates indicate it was last updated on January 25th 2023. Fortunately, there are 1,330 other studies actively recruiting participants at present."
Answered by AI
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