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:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT04037358
Eligibility Criteria:
Inclusion Criteria:
* 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 ≤ 5.0 cm or \<250 cm3
* Patient must have had their primary tumor treated with surgery and/or radiation.
* Histologic confirmation of malignancy (primary or metastatic tumor).
* PSADT \<15 months. PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA \> 0.2). To calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used. It can be found at the following web site: https://www.mskcc.org/nomograms/prostate/psa-doubling-time.
* Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed).
* PSA \> 0.5 but \<50.
* Testosterone \> 125 ng/dL.
* Patient must be ≥ 18 years of age.
* Patient must have a life expectancy ≥ 12 months.
* Patient must have an ECOG performance status ≤ 2.
* Patient must have normal organ and marrow function as defined as:
Before the first administration of Xofigo, the absolute neutrophil count (ANC) should be ≥ 1.5 x 109/L, the platelet count ≥ 100 x 109/L and hemoglobin ≥ 10 g/dL.
\* Patient must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment.
* PSMA-PET/MRI or PSMA-PET/CT scan within the past 6 months with results that demonstrate more disease lesions than baseline CT/Bone Scan
* Castration-resistant prostate cancer (CRPC).
* Spinal cord compression or impending spinal cord compression.
* Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
* Patient receiving any other investigational agents.
* Patient receiving abiraterone and prednisone.
* Patient is participating in a concurrent treatment protocol.
* Serum creatinine \> 3 times the upper limit of normal.
* Total bilirubin \> 3 times the upper limit of normal.
* Liver Transaminases \> 5-times the upper limit of normal.
* Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
* Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
* Refusal to sign informed consent.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04037358
Study Brief:
Protocol Section:
NCT04037358