NCT05520255 18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
| NCT ID | NCT05520255 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Alberta |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,800 participants |
| Start Date | 2023-07-25 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,800 participants in total. It began in 2023-07-25 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05520255 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05520255 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,800 participants.
Is NCT05520255 currently recruiting?
Yes, NCT05520255 is actively recruiting participants. Contact the research team at jabele@ualberta.ca for enrollment information.
Where is the NCT05520255 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05520255 clinical trial?
NCT05520255 is sponsored by University of Alberta. The trial plans to enroll 2,800 participants.
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