Prostate Cancer 18F-PSMA-1007 PET/CT Access Trial

Launched by ALBERTA HEALTH SERVICES · Jul 3, 2024

Keywords

ClinConnect Summary

The Prostate Cancer 18F-PSMA-1007 PET/CT Access Trial is a research study designed to find out how effective a special type of imaging called 18F-PSMA-1007 PET/CT is at diagnosing prostate cancer and its spread, compared to standard imaging techniques like CT scans, MRIs, and bone scans. The study will also look at the safety of this imaging method and see which standard imaging tests are being used when this new method is available.

To be eligible for this trial, participants need to be at least 18 years old and have a history of prostate cancer with specific blood test results indicating the disease may be returning or spreading. This includes those who have had surgery or other treatments and whose prostate-specific antigen (PSA) levels are rising. People will need to give their consent to participate and will undergo a PET/CT scan, which requires lying flat for about 30 minutes. This trial is currently not recruiting participants, but it aims to provide important insights into improving prostate cancer diagnosis and treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age greater than or equal to 18 years.
• • 2. Able and willing to follow instructions and comply with the protocol.
• • 3. Provide written informed consent prior to participation in the study.
• 4. One of the following:
• • a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 µg/L
• • 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
• • 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 ≥ 8, serum PSA \> 20 µg/L, OR minimum clinical T-stage T3a
• • 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. Age less than 18 years.
• • 3. Unable to lie flat for 30 minutes to compete PET/CT imaging.
• • 4. Lack of intravenous access