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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT05223803
Eligibility Criteria:
Inclusion Criteria:
1. Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan.
1. CT or MRI scan within 6 months of enrollment
2. Bone scan within 6 months of enrollment
3. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan)
2. Histologic confirmation of malignancy (primary or metastatic tumor).
3. Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment.
4. PSA \> 0.5 but \<100.
5. Patient must be ≥ 18 years of age.
6. Patient must have a life expectancy ≥ 12 months.
7. Patient must have an ECOG performance status ≤ 2.
8. Patient must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
1. Castration-resistant prostate cancer (CRPC).
2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy
3. Spinal cord compression or impending spinal cord compression.
4. Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
5. Patient receiving any other investigational agents.
6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .
7. Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.
8. No radiographical evidence of cranial metastasis.
9. Refusal to sign informed consent.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05223803
Study Brief:
Protocol Section:
NCT05223803