Phase 2
N=64
RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04037358 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Progression-free Survival — 10.5; 11.8 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Radium-223 (Drug); stereotactic ablative radiotherapy (SABR) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
10.5; 11.8 | — |
| SECONDARY Toxicity as Assessed by Number of Participants Who Experience Adverse Events Grade 3 or Greater (CTCAE v4.0) |
5; 3; 0; 1; 4; 1 | — |
| SECONDARY Rate of Local Control at 12 Months |
0.794; 0.908 | — |
| SECONDARY Time to Locoregional Progression |
— | — |
| SECONDARY Time to Distant Progression |
11.9; 12.1 | — |
| SECONDARY Metastasis-Free Survival |
12.3; 19.4 | — |
| SECONDARY Androgen-deprivation Therapy (ADT)-Free Survival |
16.2; 19.2 | — |
| SECONDARY Quality of Life as Assessed by Pain Severity and Pain Interference Score With Imputations Using the Brief Pain Inventory |
0.31; 0.39; 0.56; 0.27 | — |
| SECONDARY Change in Quality of Life as Assessed by Pain Severity and Pain Interference With Imputations Using the Brief Pain Inventory |
0.34; -0.01 | — |
| SECONDARY Time to New Metastatsis |
11.9; 12.0 | — |
| SECONDARY Duration of Response |
10.5; 11.8 | — |
Summary
This is a Phase II non-blinded randomized study evaluating men with oligometastatic prostate cancer lesions randomized (1:1) to stereotactic ablative radiation therapy (SABR) versus SBAR + Radium-223. We are looking to determine the progression-free survival of men who have oligometastatic prostate cancer with at least one bone metastasis with stereotactic ablative radiation therapy (SABR) versus SABR + Radium-223.
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 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 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.
Data sourced from ClinicalTrials.gov (NCT04037358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.