A Phase II Randomized Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS)
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04037358
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase: Phase 2
- Age: minimum 18 Years maximum 100 Years
- Gender: Male
- 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.
- 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.
View trial on ClinicalTrials.gov