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

Phase 2
Waitlist Available
Led By Ana Kiess, M.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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,277 Previous Clinical Trials
25,540,966 Total Patients Enrolled
44 Trials studying Prostate Cancer
26,911 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
571 Previous Clinical Trials
33,290 Total Patients Enrolled
57 Trials studying Prostate Cancer
3,364 Patients Enrolled for Prostate Cancer
Ana Kiess, M.D.Principal InvestigatorJohns Hopkins SKCCC
Phuoc Tran, M.D., Ph.D.Principal InvestigatorJohns Hopkins SKCCC
Ana Kiess, M.D., Ph.D.Principal InvestigatorJohns Hopkins SKCCC

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
~17 spots leftby Dec 2026
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