Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT04733768
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) \> 0.2 µg/L
2. Adult patients (≥ 18 years old) with 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
3. Adult patients (≥ 18 years old) 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 µg/L, OR minimum clinical T-stage T2c.
Exclusion Criteria:
1. Unable to obtain consent
2. Weight \>225 kg (weight limitation of PET/CT scanner)
3. Unable to lie flat for 30 minutes to complete the PET-CT imaging session
4. Lack of intravenous access
5. Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months
6. History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04733768
Study Brief:
Protocol Section:
NCT04733768