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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

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.

Must not have

Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).

Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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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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.

Exclusion Criteria

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

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I have swelling in my groin, penis, or legs due to cancer.

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I have severe urinary or rectal symptoms due to my cancer.

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I have undergone four or more cancer treatments for advanced prostate cancer.

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I have experienced severe side effects from docetaxel.

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I haven't taken any medications or supplements that affect PSA levels in the last 4 weeks.

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I have Crohn's disease or ulcerative colitis and have not had my colon removed.

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I have a diagnosed bone marrow disorder.

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I do not have any infections that are not responding to treatment.

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I have received treatment with medication targeting bones before.

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I need to start radiation therapy soon.

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I do not have an active HIV, Hepatitis B, or Hepatitis C infection.

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I have at least 3 lung or liver metastases or one larger than 2 cm.

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I have spinal cord compression confirmed by symptoms or MRI.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02278055

21%

Anemia

21%

Hyperglycemia

17%

Hypoalbuminemia

14%

Pain

10%

Hypomagnesemia

10%

Back pain

10%

Fatigue

10%

Alkaline phosphatase increased

10%

Hypocalcemia

10%

White blood cell decreased

Hyperkalemia

Nausea

Malaise

Creatinine increased

Platelet count decreased

Bone Pain

Hyponatremia

INR increased

Hypophosphatemia

Fever

Anorexia

Hypertension

Vomiting

Chills

Hypotension

Diarrhea

Esophageal perforation

Non-cardiac chest pain

Fracture

Weight loss

Radiculitis

Neoplasms ben/mal/unk

Buttock pain

100%

80%

60%

40%

20%

Study treatment Arm

Radium-223

Awards & Highlights

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.

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