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

Phase 2

Waitlist Available

Led By Phuoc Tran, 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

RAVENS Trial 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.

RAVENS Trial 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.

RAVENS Trial 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

RAVENS 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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

557 Previous Clinical Trials

32,836 Total Patients Enrolled

56 Trials studying Prostate Cancer

3,284 Patients Enrolled for Prostate Cancer

Phuoc Tran, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile suitable for participation in this research project?

"This clinical trial seeks to enrol 64 individuals with prostate cancer that are aged between 18 - 100. To be considered, the patient must have a maximum of three asymptomatic metastases in bone or soft tissue (with at least one being in the bone), histologically confirmed malignancy and their primary tumor treated surgically/radiographically. Additionally, they should display Prostate Specific Antigen Doubling Time below 15 months, PSA levels above 0.5 but lower than 50 ng/dL; testosterone greater than 125ng/dL; Eastern Cooperative Oncology Group performance status 2 or less; life expectancy of 12+ months"

Answered by AI

Is the research facility currently enrolling participants?

"According to clinicaltrials.gov, this medical trial which was first introduced on August 9th 2019 is still searching for new patients and has seen recent updates as of May 25th 2022."

Answered by AI

Has anything similar been attempted with this type of research before?

"Currently, there are 7 ongoing trials for stereotactic ablative radiotherapy (SABR) over 4 countries and 40 cities. This therapy was first trialled by Merck Sharp & Dohme LLC back in 2017 with 45 participants completing Phase 2 approval. 8 studies have been successfully closed since then."

Answered by AI

How many participants are being enrolled in the trial?

"Affirmative. Data available on clinicaltrials.gov confirms that this experiment, which was initially made public on August 9th 2019, is currently recruiting research subjects. Approximately 64 individuals need to be recruited from a single medical centre."

Answered by AI

Is the eligibility criteria for this medical trial limited to adults aged eighteen or over?

"This clinical trial is recruiting patients aged 18 and over, up to the ripe age of 100."

Answered by AI

Has the FDA sanctioned stereotactic ablative radiotherapy (SABR) as an effective treatment?

"The safety of stereotactic ablative radiotherapy (SABR) is assessed as a 2 due to the lack of clinical data in support of efficacy, although there are some trials that back up its security."

Answered by AI

Could you explain the results of prior experiments involving stereotactic ablative radiotherapy (SABR)?

"Currently, there are 7 studies investigating the efficacy of stereotactic ablative radiotherapy (SABR), with one trial already in its third phase. 62 different medical sites across Canada have opened their doors to offer this form of therapy, with a majority being based out Toronto."

Answered by AI

Recent research and studies

BMC CancerJournal

A Phase II Randomized Trial of Radium-223 Dichloride and SABR Versus SABR for Oligometastatic Prostate Cancers (RAVENS)

Hasan, Hamza, Matthew P. Deek, Ryan Phillips, Robert F. Hobbs, Reem Malek, Noura Radwan, Ana P. Kiess, et al.. 2020. “A Phase II Randomized Trial of Radium-223 Dichloride and SABR Versus SABR for Oligometastatic Prostate Cancers (RAVENS)”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-020-07000-2.

clinicaltrials.govStudy

RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers

2019. "RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04037358.

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