Using 18F-PSMA-1007 PET/CT imaging for prostate cancer assessment
18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
This study is testing a new type of imaging called 18F-PSMA-1007 PET/CT to see if it can help adults with prostate cancer who have certain medical histories and rising PSA levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2800 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05520255 on ClinicalTrials.gov |
What this trial studies
This phase III interventional study evaluates the effectiveness of 18F-PSMA-1007 PET/CT imaging in adults with prostate cancer who have specific clinical histories, such as prior radical prostatectomy or rising PSA levels after other treatments. The study aims to identify patients who may benefit from this imaging technique based on their medical history and current PSA levels. Participants will be recruited from two centers, focusing on those with high-risk features for metastatic disease or those for whom the imaging is deemed clinically beneficial by their healthcare providers.
Who should consider this trial
Good fit: Ideal candidates include adults with a history of prostate cancer treatments and specific PSA levels indicating potential metastatic disease.
Not a fit: Patients without a history of prostate cancer or those whose PSA levels do not meet the study criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer assessments and improve treatment planning for patients.
How similar studies have performed: Other studies utilizing advanced imaging techniques for prostate cancer have shown promising results, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Jonathan T Abele, MD
- Email: jabele@ualberta.ca
- Phone: 780-407-6907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.