18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028

Launched by UNIVERSITY OF ALBERTA · Aug 25, 2022

Keywords

ClinConnect Summary

The Access Trial is a clinical study aimed at evaluating a special type of imaging called 18F-PSMA-1007 PET/CT in men with prostate cancer. This trial is looking for adult participants who have had prostate surgery, or treatments like radiation or cryotherapy, and have certain levels of a blood marker called PSA that suggest their cancer may be active again. It also includes patients with a history of prostate cancer who are considered at high risk for the disease spreading. Even if someone doesn’t meet these specific criteria but their doctor believes this imaging could be helpful, they may still be eligible to participate.

If you decide to join the trial, you will undergo a PET/CT scan where a small amount of a radioactive tracer will be injected to help see your prostate cancer more clearly. The researchers will monitor you for any side effects during and after the scan. They will also keep track of any unusual bone lesions seen in the images to determine if they are harmful or not. This study is currently recruiting participants, and it’s important to note that you must be at least 18 years old and live in Alberta or certain northern territories in Canada to qualify.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. 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 \< 9 months
• • 3. 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 therapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
• • 4. 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 physician (licensed in Alberta)
• Exclusion Criteria:
• • 1. Unable to obtain consent
• • 2. Weight \> 225 kg (weight limit of PET/CT scanners)
• • 3. Unable to lie flat for 30 minutes to complete the PET/CT imaging session
• • 4. Lack of intravenous access
• • 5. History of allergic reaction to 18F-PSMA-1007
• • 6. Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
• • 7. Less than 18 years old
• • NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation