EICHORCondition: Prostate Cancer · Sponsor: University of Alberta
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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 \< 9 months 3. Adult patients with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. 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-PDAM-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) The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways: 1. The participant will be screened for adverse effects immediately post-injection 2. The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection) 3. The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-…
This description comes directly from the study's public registry record.
Jonathan T Abele, MD · 780-407-6907 · jabele@ualberta.ca
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| University of Alberta | Edmonton, Alberta, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05520255