Radium-223 + SABR for Prostate Cancer (RAVENS Trial)

Palo Alto (17 mi)

Phuoc T. Tran – Johns Hopkins Physical ...

Overseen byAna 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

I can take care of myself and perform daily activities.

My cancer diagnosis was confirmed through tissue examination.

My blood tests show normal white blood cells, platelets, and hemoglobin levels.

I am 18 years old or older.

My initial cancer was treated with surgery or radiation.

I have 1-3 painless bone or soft tissue tumors developed in the last 6 months, each not larger than 5.0 cm.

Exclusion Criteria

My recent scans show more cancer spots than before.

I am currently taking abiraterone and prednisone.

I have or am at risk of having pressure on my spinal cord.

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

My prostate cancer is not responding to hormone therapy.

I cannot lie flat for scans or certain cancer treatments.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Radium-223 and SABRExperimental Treatment2 Interventions

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

Group II: SABRActive Control1 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: