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

Phase 2

Waitlist Available

Led By Ana Kiess, M.D., Ph.D.

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have an ECOG performance status ≤ 2

Histologic confirmation of malignancy (primary or metastatic tumor)

Must not have

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

Patient receiving abiraterone and prednisone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

This trial is testing whether adding Radium-223 to SABR treatment for men with oligometastatic prostate cancer improves progression-free survival.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include radiation-related symptoms such as fatigue, skin reactions, nausea, and potential bone marrow suppression from Radium-223 leading to anemia or increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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My cancer diagnosis was confirmed through tissue examination.

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

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I am 18 years old or older.

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My initial cancer was treated with surgery or radiation.

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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

You may be eligible for the trial if you check “No” for criteria below:

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My recent scans show more cancer spots than before.

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I am currently taking abiraterone and prednisone.

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

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

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My prostate cancer is not responding to hormone therapy.

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I cannot lie flat for scans or certain cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival

Secondary outcome measures

ADT-free survival

Local control at 12 months

Quality of Life as assessed by Pain Severity and Pain Interference using the Brief Pain Inventory

+4 more

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radium-223

2023

Completed Phase 2

~100

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor

2,251 Previous Clinical Trials

25,336,852 Total Patients Enrolled

41 Trials studying Prostate Cancer

26,060 Patients Enrolled for Prostate Cancer

Department of Defense Congressionally Directed Medical Research ProgramUNKNOWN

2 Previous Clinical Trials

576 Total Patients Enrolled

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

563 Previous Clinical Trials

33,260 Total Patients Enrolled

57 Trials studying Prostate Cancer

3,364 Patients Enrolled for Prostate Cancer

Media Library

Stereotactic Ablative Radiotherapy (SABR) Clinical Trial Eligibility Overview. Trial Name: NCT04037358 — Phase 2

Prostate Cancer Research Study Groups: Radium-223 and SABR, SABR

Prostate Cancer Clinical Trial 2023: Stereotactic Ablative Radiotherapy (SABR) Highlights & Side Effects. Trial Name: NCT04037358 — Phase 2

Stereotactic Ablative Radiotherapy (SABR) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04037358 — Phase 2

~21 spots leftby Dec 2026

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