18F-PSMA-1007 PET/CT in Prostate Cancer – Access Trial 2022 to 2028
18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
About This Trial
- This study is testing an advanced type of body scan designed to clearly locate prostate cancer cells in the body.
- It is open to adults with newly diagnosed, high-risk prostate cancer, as well as those whose cancer markers are rising again after past treatments like surgery or radiation.
- To take part, you will receive an injection through an IV and must be able to comfortably lie flat for a 30-minute scan.
- The study team will monitor you for any side effects, and participants must live in Alberta, the Northwest Territories, or Yukon to join.
More Information
- A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 1.
- Adults patients (≥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 patients 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 2.5 but no corresponding lesion on CT) will be recorded 2.
- The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant) 3.
- Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021) 4.
- Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing an advanced type of body scan designed to clearly locate prostate cancer cells in the body.
Study Details
- Start Date: July 25, 2023
- Lead Sponsor: University of Alberta
Full Eligibility Criteria
Inclusion 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 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
Treatments
- Drug: 18F-PSMA-1007