Radium-223 + SABR for Prostate Cancer

(RAVENS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ana Kiess, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Men over 18 with oligometastatic prostate cancer, treated primary tumor, PSA levels between 0.5-50, and at least one recent bone metastasis are eligible. They must have normal organ/marrow function and a life expectancy of over a year. Those with more than three years of ADT history or recent treatment aren't eligible.

Inclusion Criteria

PSA > 0.5 but <50

Testosterone > 125 ng/dL

My prostate cancer is progressing quickly.

Exclusion Criteria

My recent scans show more cancer spots than before.

I have suspected lung or liver cancer spread larger than 10 mm.

I am currently taking abiraterone and prednisone.

Participant Groups

This Phase II trial compares the effectiveness of SABR alone versus SABR combined with Radium-223 in men with oligometastatic prostate cancer to see which is better for halting disease progression.

Group I: Radium-223 and SABR Experimental Treatment 2 Interventions

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

Group II: SABR Active Control 1 Intervention

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

Stereotactic Ablative Radiotherapy (SABR) is already approved in European Union, United States, United Kingdom for the following indications:

🇪🇺 Approved in European Union as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer

🇺🇸 Approved in United States as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer
• Recurrent prostate cancer

🇬🇧 Approved in United Kingdom as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins Baltimore, MD

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Lead Sponsor

Bayer Industry Sponsor

Department of Defense Congressionally Directed Medical Research Program Collaborator

References