Your session is about to expire
← Back to Search
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
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.
Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
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 belowSelect...
My cancer has grown by 20% or more, or I have new cancer spots since starting treatment.
Select...
My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.
Select...
My prostate cancer diagnosis was confirmed through lab tests.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My bone disease has worsened or I have two or more new bone lesions.
Select...
I have two or more bone lesions.
Select...
I am a man aged 18 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 • NCT0227805521%
Hyperglycemia
21%
Anemia
17%
Hypoalbuminemia
14%
Pain
10%
Fatigue
10%
Alkaline phosphatase increased
10%
Back pain
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%
Hypertension
3%
Non-cardiac chest pain
3%
Weight loss
3%
Anorexia
3%
Buttock pain
3%
Fracture
3%
Radiculitis
3%
Hypotension
3%
Vomiting
3%
Fever
3%
Chills
3%
Neoplasms ben/mal/unk
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?
BayerIndustry Sponsor
2,248 Previous Clinical Trials
25,332,781 Total Patients Enrolled
39 Trials studying Prostate Cancer
25,289 Patients Enrolled for Prostate Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,941 Previous Clinical Trials
588,178 Total Patients Enrolled
132 Trials studying Prostate Cancer
50,774 Patients Enrolled for Prostate Cancer
Michael Morris, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
15 Previous Clinical Trials
2,131 Total Patients Enrolled
11 Trials studying Prostate Cancer
202 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swelling in my groin, penis, or legs due to cancer.I haven't taken any experimental cancer treatments or other cancer therapies in the last 4 weeks.I have severe urinary or rectal symptoms due to my cancer.Any side effects from my previous treatments are mild.I have had chemotherapy for prostate cancer after it became resistant to hormonal therapy.I have undergone four or more cancer treatments for advanced prostate cancer.I have experienced severe side effects from docetaxel.I have not had blood transfusions or growth factors in the last 4 weeks.I haven't taken any medications or supplements that affect PSA levels in the last 4 weeks.You have a serious illness or medical condition that the doctor thinks would make this study too risky for you.I have Crohn's disease or ulcerative colitis and have not had my colon removed.I do not have an active cancer other than non-melanoma skin, non-invasive bladder cancer, or other non-invasive cancers.I have a diagnosed bone marrow disorder.I do not have any infections that are not responding to treatment.My cancer has grown by 20% or more, or I have new cancer spots since starting treatment.You have been diagnosed with advanced prostate cancer that is getting worse based on certain medical tests.My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.I have received treatment with medication targeting bones before.I had external beam radiotherapy in the last 4 weeks.I need to start radiation therapy soon.I may have had docetaxel or abiraterone for my cancer, but it's not counted as a prior treatment line.I do not have an active HIV, Hepatitis B, or Hepatitis C infection.My prostate cancer diagnosis was confirmed through lab tests.I am fully active and can carry on all my pre-disease activities without restriction.I have at least 3 lung or liver metastases or one larger than 2 cm.My bone disease has worsened or I have two or more new bone lesions.I have two or more bone lesions.I am a man aged 18 or older.My recent tests show my organs are functioning well.I have spinal cord compression confirmed by symptoms or MRI.I have severe heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Docetaxel
- Group 2: Docetaxel with Radium-223
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger