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Radioactive Agent

Radium-223 for Recurrent Prostate Cancer

Phase 2

Recruiting

Led By Ravi A Madan, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

- Adequate renal function defined by eGFR within normal as predicted by the CKD-EPI equation (>= 50 mL/min/1.73m^2) or by measure of creatinine clearance from 24-hour urine collection.

- ECOG performance status of 0 1

Must not have

PET scan findings suggesting visceral disease.

History of prior systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium 223 dichloride).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how Radium-223 affects men with rising PSA but no evidence of cancer on conventional CT or bone scan, but positive findings on PET or molecular imaging in the bones.

Who is the study for?

Men 18+ with prostate cancer, post-surgery or radiation, showing rising PSA levels but no visible disease on CT/MRI scans. They must have positive bone findings on PET scans (lymph nodes allowed), normal organ function tests, and agree to use contraception. Excluded are those with other active cancers within 3 years (except certain skin/bladder cancers), compromised immune systems, recent major surgery or systemic therapy.

What is being tested?

The trial is testing Radium-223's effect on biochemically recurrent prostate cancer that's detectable only by PSA in the blood and not by standard imaging. It examines how this treatment impacts the immune system and its influence on PSA levels and imaging results over six cycles of treatment.

What are the potential side effects?

Potential side effects include radiation-related symptoms such as nausea, diarrhea, fatigue; possible bone marrow suppression leading to anemia or infection risk; and localized reactions at injection sites. Long-term follow-up will monitor for any additional adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is normal based on tests.

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I can carry out all my daily activities without help.

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I am 18 years old or older.

Exclusion Criteria

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

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My PET scan shows signs of internal organ disease.

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I have been treated with specific radioactive drugs before.

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I am taking medications that can change my PSA levels, like finasteride.

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I do not have HIV or any condition that weakens my immune system.

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I have had chemotherapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

changes in immune cell populations

Secondary study objectives

Changes in PSA kinetics

Changes in PSA kinetics and the changes in immune cell populations relative to patients with similar disease undergoing a surveillance period on a similar protocol (NCT02649439)

Safety and tolerability of radium-223