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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT05709535
Eligibility Criteria:
Inclusion Criteria:
1. Study participant has provided informed consent prior to initiation of any study specific activities/procedures.
2. Age greater than or equal to 18 years.
3. Subjects with histological diagnosis of prostate cancer.
4. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy, with two consecutive PSA values \>0.2 ng/ml measured more than 6 weeks after radical prostatectomy. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL OR
6. Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy and subsequently treated by salvage radiotherapy or pelvic node dissection, with two consecutive PSA values \>0.2 ng/ml. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL OR
7. Subjects with biochemical recurrence of prostate cancer after initial curative therapy with radiation therapy (including brachytherapy), or non-standard local ablative therapy (such as high frequency ultrasound, cryoablation, focal laser ablation, etc.), with a PSA level \>2 ng/mL above the nadir after radiation therapy OR
8. Subjects with advanced castration sensitive or castration resistant prostate cancer being considered for localized treatment (surgery, brachytherapy, radiotherapy) of recurrent or oligometastatic prostate cancer. Castration resistance is defined as a PSA level \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L) OR
9. Subjects with metastatic or castration resistant prostate cancer being evaluated for systemic therapy administered in therapeutic clinical trials. The PSA level must be \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L) OR
10. Subjects with high-risk prostate cancer, defined as T3a, Gleason ≥8, or PSA ≥20, and "very high risk" as T3b or T4 disease.
11. Patients of childbearing potential must adhere to the contraception requirement from screening throughout the study period up to 90 days after the last dose of study intervention.
Exclusion Criteria:
1. Unable to lie supine for the duration of imaging.
2. Unable to provide written consent.
3. Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm).
4. Lack of IV access.
5. History of allergic reaction to \[18F\]-PSMA-1007.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05709535
Study Brief:
Protocol Section:
NCT05709535