PSMA PET/CT Scan for Prostate Cancer
Trial Summary
What is the purpose of this trial?
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 (1-7 days post injection) The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows: 1. All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax \> 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
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, it does mention that androgen deprivation therapy (ADT) is allowed, so you can continue that treatment if applicable.
What data supports the effectiveness of the treatment 18F-PSMA-1007 PET/CT for prostate cancer?
Research shows that 18F-PSMA-1007 PET/CT is effective in staging prostate cancer, especially in high-risk cases and in detecting recurrent disease after initial treatment. It is advantageous because it can be produced in larger quantities and has a longer shelf life, making it more accessible for patients.12345
Is the 18F-PSMA-1007 PET/CT scan safe for humans?
The 18F-PSMA-1007 PET/CT scan has been studied for safety in both healthy volunteers and prostate cancer patients, and it is generally considered safe for human use. The studies focused on its biodistribution (how it spreads in the body) and radiation dosimetry (measurement of radiation exposure), indicating it is well-tolerated.45678
How is the PSMA PET/CT scan treatment for prostate cancer different from other treatments?
The PSMA PET/CT scan for prostate cancer is unique because it uses a special radiotracer, fluorine-18 PSMA-1007, which is not excreted through the kidneys, allowing for clearer imaging of the pelvic area. This makes it particularly useful for staging high-risk prostate cancer and locating recurrent disease, offering advantages over other imaging methods like multi-parametric MRI.345910
Research Team
Eligibility Criteria
This trial is for adults with prostate cancer who've had surgery or other treatments like radiotherapy, and now have rising PSA levels or high-risk features indicating possible metastatic disease. It's also open to those where a PET/CT scan might help in their care as decided by certain specialists in Alberta.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Tracer Injection and Immediate Safety Assessment
Participants receive a single dose of 18F-PSMA-1007 and are screened for adverse effects immediately post-injection
Post-Scan Safety Assessment
Participants are screened for adverse effects immediately after the PET/CT scan, approximately 2.5 hours after tracer injection
Delayed Safety Monitoring
Participants are provided with information to self-report any delayed adverse events occurring 1-7 days post-injection
Follow-up
Participants' non-specific bone lesions are evaluated to determine if they are benign or malignant, based on reference standards
Treatment Details
Interventions
- 18F-PSMA-1007 (Radiopharmaceutical)
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Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor