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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately (within 15 minutes) after 18f-psma-1007 injection
Awards & highlights
Study Summary
This trial is studying how well 18F-PSMA-1007 PET/CT imaging works in patients with prostate cancer that has come back or is high-risk.
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.Check my eligibility
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.See study design
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 belowSelect...
I am an adult who has had prostate cancer treatment and my PSA is rising or doubling quickly.
Select...
I am an adult with prostate cancer, high Gleason score, PSA > 20, or T-stage T2c or higher.
Select...
I am over 18, had prostate surgery, and my PSA level is above 0.2 µg/L.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately (within 15 minutes) after 18f-psma-1007 injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately (within 15 minutes) after 18f-psma-1007 injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biodistribution
Diagnostic Accuracy
Safety - delayed
+2 moreSecondary outcome measures
Clinical Efficacy
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
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,678 Total Patients Enrolled
9 Trials studying Prostate Cancer
5,454 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult who has had prostate cancer treatment and my PSA is rising or doubling quickly.I am an adult with prostate cancer, high Gleason score, PSA > 20, or T-stage T2c or higher.I cannot lie flat for 30 minutes.My weight is under 225 kg.I've had a CT scan and bone scan in the last 3 months.I am over 18, had prostate surgery, and my PSA level is above 0.2 µg/L.
Research Study Groups:
This trial has the following groups:- Group 1: 18F-PSMA-1007 PET/CT scan
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.
How does 18F-PSMA-1007 compare to other treatments in terms of safety for patients?
"The safety of 18F-PSMA-1007 has been deemed a 2 due to the Phase 2 nature of this trial, indicating that while no clinical data exists conclusively validating efficacy, there is some evidence for safety."
Answered by AI
Are there still any vacancies for prospective participants in this research project?
"According to the information located on clinicaltrials.gov, this trial is not actively seeking participants. This research project was first listed in August of 2021 and last edited in August 2022; nonetheless, there are 1321 other trials currently recruiting volunteers at this moment."
Answered by AI
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