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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
- Presence of findings on PET scan (i.e., NaF PET scan) suspicious for metastatic prostate cancer in bone. Note: while lymph node findings would be allowed and provide the opportunity for the assessment of any abscopal effects, PET scan findings suggesting visceral disease will be excluded.
- Recovery from acute toxicity related to prior therapy, including surgery and radiation, (defined as no toxicity >= grade 2).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 PET scan shows possible prostate cancer spread to bones, but not to organs.
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I have recovered from side effects of my previous cancer treatments.
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I agree to use effective birth control during and 6 months after the study.
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I haven't had any other cancers except for skin cancer or bladder cancer in situ in the last 3 years.
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My kidney function is normal based on tests.
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My scans show no signs of prostate cancer spread.
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My liver function tests are within the required range.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
changes in immune cell populations
Secondary outcome measures
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

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02278055
21%
Anemia
21%
Hyperglycemia
17%
Hypoalbuminemia
14%
Pain
10%
Back pain
10%
Alkaline phosphatase increased
10%
Fatigue
10%
Hypomagnesemia
10%
White blood cell decreased
10%
Hypocalcemia
7%
Bone Pain
7%
Nausea
7%
Malaise
7%
Hyperkalemia
7%
INR increased
7%
Platelet count decreased
7%
Creatinine increased
7%
Hyponatremia
7%
Hypophosphatemia
3%
Neoplasms ben/mal/unk
3%
Anorexia
3%
Non-cardiac chest pain
3%
Weight loss
3%
Buttock pain
3%
Hypertension
3%
Fracture
3%
Radiculitis
3%
Hypotension
3%
Vomiting
3%
Fever
3%
Chills
3%
Diarrhea
3%
Esophageal perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Radium-223

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment2 Interventions
Participants will receive radium-223 treatment every 4 weeks for up to 6 cycles. 18F-NaF PET scans will be used to assess response in bone.
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?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,321 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,171 Patients Enrolled for Prostate Cancer
Ravi A Madan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
17 Previous Clinical Trials
1,112 Total Patients Enrolled
12 Trials studying Prostate Cancer
976 Patients Enrolled for Prostate Cancer

Media Library

Radium-223 (Radioactive Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04206319 — Phase 2
Prostate Cancer Research Study Groups: 1
Prostate Cancer Clinical Trial 2023: Radium-223 Highlights & Side Effects. Trial Name: NCT04206319 — Phase 2
Radium-223 (Radioactive Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04206319 — Phase 2

Frequently Asked Questions

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

Can you share any other research that has looked at Radium-223?

"Radium-223 has 15 ongoing trials, 3 of which are in Phase 3. Some of these studies are based in Kuala Lumpur or WP Kuala Lumpur, but there are 83 total locations running clinical trials for Radium-223."

Answered by AI

How is Radium-223 most commonly used?

"Radium-223, while most commonly used to treat dentures, can also be used as a form of parenteral nutrition or to address trace element deficiencies and total dental decay."

Answered by AI

Are there any patients who can still join this clinical trial?

"That is correct. The clinical trial indicated on clinicaltrials.gov is still actively looking for participants. This study was first posted on September 22nd, 2020 and was last updated on November 9th, 2020. Currently, 26 individuals are needed to enroll at 1 site."

Answered by AI

How many individuals are taking part in this research project?

"That is accurate, the trial detailed on clinicaltrials.gov is presently recruiting patients. This experiment was initially posted on September 22nd 2020 and was most recently updated on November 9th 2020. 1 medical facility is looking to enroll 26 individuals in total."

Answered by AI

Does Radium-223 have a high potential to harm patients?

"Radium-223 receives a 2 for safety from our Power team because, although Phase 2 trials have not yet yielded data to support efficacy, there is some evidence that it is safe."

Answered by AI
~4 spots leftby Nov 2024