RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers

NCT04037358 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: J18147IRB00188450
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Time to progression in men who have oligometastatic prostate cancer after therapy. Progression is defined by PCWG2 criteria as follows: \>=25% increase in PSA from nadir (and by \>=2ng/mL), and/or clinical/radiographic progression (clinical progression = symptomatic progression, worsening of disease-related symptoms or new cancer-related complications; radiographic progression on CT scan defined by RECIST 1.1 criteria: \>=20% enlargement in sum diameter of soft-tissue target lesions; or on bone scan \>=1 new bone lesions), initiation of ADT or death due to any cause, whichever occurs first.

  Up to 24 months

Secondary Outcomes (10)

• Toxicity as Assessed by Number of Participants Who Experience Adverse Events Grade 3 or Greater (CTCAE v4.0)

  Up to 24 months

• Rate of Local Control at 12 Months

  Up to 12 months

• Time to Locoregional Progression

  12 months

• Time to Distant Progression

  Up to 24 months

• Metastasis-Free Survival

  Up to 24 months

Study Arms (2)

Radium-223 and SABR

EXPERIMENTAL

First radium-223 infusion will be within two weeks of SABR

Drug: Radium-223; Radiation: stereotactic ablative radiotherapy (SABR)

SABR

ACTIVE COMPARATOR

SABR(1-5 fractions) will be administered for all men

Radiation: stereotactic ablative radiotherapy (SABR)

Interventions

Radium-223 DRUG

Radium-223 plus SABR will be within two weeks.

Radium-223 and SABR

stereotactic ablative radiotherapy (SABR) RADIATION

SABR 1-5 fractions

Radium-223 and SABR; SABR

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Bayer: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Wang 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 RESULT

• Hasan 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radium-223

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Treatment and follow-up occurred during the COVID-19 pandemic, leading to assessment biases associated with telemedicine encounters. This study was conducted before routine use of molecular imaging (not mandated) to corroborate disease burden detected on conventional imaging. The study size is small and limits the prognostic correlates observed.

Results Point of Contact

• Title: Dr. Ana P. Kiess
• Organization: Johns Hopkins University School of Medicine

akiess1@jhmi.edu

443-287-7528

Study Officials

• Ana Kiess, M.D.

  Johns Hopkins SKCCC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RAdium-223 and SABR Versus SABR (Stereotactic Ablative Radiotherapy)

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: August 9, 2019
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)