Clinical trial · Interventional
RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers
A Phase II Randomized Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 | Drug | — | UNRESOLVED |
| stereotactic ablative radiotherapy (SABR) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radium-223 and SABR
- description
- First radium-223 infusion will be within two weeks of SABR
- interventionNames
- Drug: Radium-223
- Radiation: stereotactic ablative radiotherapy (SABR)
- type
- ACTIVE_COMPARATOR
- label
- SABR
- description
- SABR(1-5 fractions) will be administered for all men
- interventionNames
- Radiation: stereotactic ablative radiotherapy (SABR)
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTWang JH, Sherry AD, Bazyar S, Sutera P, Radwan N, Phillips RM, Deek MP, Lu J, Dipasquale S, Deville C, DeWeese TL, Song DY, Wang H, Hobbs RF, Malek R, Dudley SA, Greco SC, Antonarakis ES, Marshall CH, Denmeade S, Paller CJ, Carducci MA, Pienta KJ, Oz OK, Ramotar M, Leenstra JL, Park SS, Abramowitz MC, Desai N, Berlin A, Stish BJ, Tang C, Tran PT, Kiess AP. Outcomes of Radium-223 and Stereotactic Ablative Radiotherapy Versus Stereotactic Ablative Radiotherapy for Oligometastatic Prostate Cancers: The RAVENS Phase II Randomized Trial. J Clin Oncol. 2025 Jun 20;43(18):2059-2068. doi: 10.1200/JCO-25-00131. Epub 2025 May 7. PMID 40334149
- DERIVEDHasan H, Deek MP, Phillips R, Hobbs RF, Malek R, Radwan N, Kiess AP, Dipasquale S, Huang J, Caldwell T, Leitzel J, Wendler D, Wang H, Thompson E, Powell J, Dudley S, Deville C, Greco SC, Song DY, DeWeese TL, Gorin MA, Rowe SP, Denmeade S, Markowski M, Antonarakis ES, Carducci MA, Eisenberger MA, Pomper MG, Pienta KJ, Paller CJ, Tran PT. A phase II randomized trial of RAdium-223 dichloride and SABR Versus SABR for oligomEtastatic prostate caNcerS (RAVENS). BMC Cancer. 2020 Jun 1;20(1):492. doi: 10.1186/s12885-020-07000-2. PMID 32487038