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Cytotoxic Chemotherapy Agent

Radium-223 + Docetaxel for Prostate Cancer

Phase 3
Recruiting
Led By Michael Morris, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.
Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is comparing the efficacy of adding Radium-223 to Docetaxel chemotherapy versus Docetaxel chemotherapy alone in men with metastatic hormone-refractory prostate cancer.

Who is the study for?
This trial is for males over 18 with progressive prostate cancer, who have not had certain recent treatments or a second active malignancy. They must have normal organ function, agree to birth control measures, and be willing to follow the study protocol.Check my eligibility
What is being tested?
The study tests if combining Radium-223 with Docetaxel chemotherapy is more effective than using Docetaxel alone in treating prostate cancer. Participants will receive one of these treatment regimens to compare outcomes.See study design
What are the potential side effects?
Docetaxel may cause side effects like low blood cell counts leading to infection risk, allergic reactions, hair loss, and nail changes. Radium-223 can lead to nausea, diarrhea, vomiting and bone marrow suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Any side effects from my previous treatments are mild.
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My cancer has grown by 20% or more, or I have new cancer spots since starting treatment.
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My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.
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My prostate cancer diagnosis was confirmed through lab tests.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My bone disease has worsened or I have two or more new bone lesions.
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I have two or more bone lesions.
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I am a man aged 18 or older.
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My recent tests show my organs are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival

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

2Treatment groups
Experimental Treatment
Group I: Docetaxel with Radium-223Experimental Treatment2 Interventions
Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
Group II: DocetaxelExperimental Treatment1 Intervention
Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel 75 mg/m2
2012
Completed Phase 2
~220
Docetaxel 60 mg/m2
2012
Completed Phase 2
~220
Radium-223
2023
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
596,966 Total Patients Enrolled
131 Trials studying Prostate Cancer
65,156 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,233 Previous Clinical Trials
25,325,579 Total Patients Enrolled
38 Trials studying Prostate Cancer
25,181 Patients Enrolled for Prostate Cancer
Michael Morris, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
14 Previous Clinical Trials
1,931 Total Patients Enrolled
11 Trials studying Prostate Cancer
202 Patients Enrolled for Prostate Cancer

Media Library

Docetaxel (Cytotoxic Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03574571 — Phase 3
Prostate Cancer Research Study Groups: Docetaxel, Docetaxel with Radium-223
Prostate Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT03574571 — Phase 3
Docetaxel (Cytotoxic Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03574571 — Phase 3

Frequently Asked Questions

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

Are there any current openings for participants in this experiment?

"The clinical trial is still recruiting patients and the most recent information available was edited on March 30th, 2022. The original posting date for this trial was June 19th, 2018."

Answered by AI

Are there any other examples of Radium-223 being used in a clinical capacity?

"There are currently 344 ongoing clinical trials researching the effects of Radium-223. Out of these, 132 are in Phase 3. The city with the most trials is Fuzhou, Fujian but there are 23106 locations running studies for Radium-223 globally."

Answered by AI

Is this trial being conducted in more than one state?

"Patients are currently being accepted at the Houston Methodist Hospital in Houston, Texas; MD Anderson Cancer Center at Cooper in Camden, Illinois; and Rush University Medical Center in Chicago, Minnesota. In addition, there are 38 other medical facilities where patients can enroll."

Answered by AI

What cancers has Radium-223 been effective in treating?

"Radium-223 is an effective treatment for malignant neoplasms, advance directives, and sarcoma."

Answered by AI

How does Radium-223 impact patients negatively?

"Radium-223's safety was given a 3 because there is both efficacy and safety data from multiple sources."

Answered by AI

How many participants are included in this clinical trial?

"That is correct, the information on clinicaltrials.gov does show that this particular trial is looking for patients at the moment. The original posting was on 6/19/2018 and there have been updates as recently as 3/30/2022. They are searching for 738 participants in total, to be recruited from 38 different locations."

Answered by AI
~202 spots leftby Jun 2026