Prostate Cancer study: 18F-PSMA-1007
Official title 18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
ClinicalTrials.gov ID: NCT05520255
What this study is testing
What is 18F-PSMA-1007?
This is an investigational imaging agent being studied to help detect prostate cancer in specific patient groups. It is designed to bind to proteins on the surface of prostate cancer cells so that a PET/CT scanner can create detailed images of where the cancer may be.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well this new scan finds prostate cancer that may have come back after surgery or radiation.
- Who it's for
- It is for men over 18 who have had prostate cancer treated with surgery or radiation and now have rising blood test results.
- What's involved
- Participants will get a special PET scan and have their blood tested. Doctors will check the scan results against other tests to see if they are accurate.
- Time commitment
- The study lasts at least one year after the scan to confirm the results.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen...
- Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively...
- Adult participants with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical...
- Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a...
You likely can't join if
- Unable to obtain consent
- Weight \> 225 kg (weight limit of PET/CT scanners)
- Unable to lie flat for 30 minutes to complete the PET/CT imaging session
- Lack of intravenous access
- History of allergic reaction to 18F-PSMA-1007
- Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
See the full eligibility criteria
- Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
- Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of...
- Adult participants with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or other similar...
- Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine...
- Unable to obtain consent
- Weight \> 225 kg (weight limit of PET/CT scanners)
- Unable to lie flat for 30 minutes to complete the PET/CT imaging session
- Lack of intravenous access
- History of allergic reaction to 18F-PSMA-1007
- Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
- Less than 18 years old NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation
The study team makes the final eligibility decision.
Where it is enrolling
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Edmonton, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.