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Hormone Therapy

Radium-223 + Hormone Therapy + SBRT for Metastatic Prostate Cancer

Phase 2

Waitlist Available

Led By Savita Dandapani, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

* Castration resistance defined as progression of disease despite serum testosterone level of < 50 ng/dL

* Only luteinizing hormone-releasing hormone (LHRH) agonist/antagonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not count

Must not have

Prior radium Ra 223 dichloride

Concomitant radiation treatment to primary prostate site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is studying radium Ra 223 dichloride, hormone therapy, and stereotactic body radiation to treat prostate cancer that has spread to other parts of the body.

Who is the study for?

This trial is for men with prostate cancer that has spread, who have started hormone therapy recently and have a life expectancy over 12 months. They should not have had chemotherapy for metastatic disease but may have tried one non-chemotherapy treatment. Men must be able to undergo radiation if they haven't already treated the primary tumor site, and their blood counts and liver function need to meet specific levels.

What is being tested?

The study tests combining radium Ra 223 (a radioactive substance targeting bone metastases), hormone therapy (lowering testosterone), and stereotactic body radiation (precise high-dose radiation) in treating advanced prostate cancer. The goal is to see if this combination works better than current treatments.

What are the potential side effects?

Possible side effects include fatigue, nausea, bone marrow suppression leading to low blood cell counts, potential harm to normal tissues from radiation, hormonal changes due to therapy like hot flashes or sexual dysfunction, and typical risks associated with receiving radioactivity.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has progressed despite low testosterone levels.

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I am only on LHRH treatment for my cancer, not just antiandrogens like bicalutamide.

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I am able to get out of my bed or chair and move around.

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I have been diagnosed with prostate cancer.

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My cancer has spread to other parts of my body.

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I will have surgery to reduce my prostate cancer before other treatments.

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My condition is not resistant to hormone therapy.

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I have up to 4 areas where my cancer has spread.

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I have at least one bone lesion and all my non-organ tumors are smaller than 5 cm.

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I have chosen not to receive the standard chemotherapy for my metastatic disease.

Exclusion Criteria

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

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I have previously received radium Ra 223 treatment.

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I am receiving radiation therapy targeted at my prostate.

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I have undergone orchiectomy.

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My health conditions, like heart problems, are under control.

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I have or had brain metastases.

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My HIV infection is not under control.

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I have had radiation for cancer that spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Objective response rate

Time to treatment failure

Secondary study objectives

Bone specific progression-free survival

Complete response (CR) rate defined as the proportion of patients achieving CR

Duration of overall complete response

+4 more

Other study objectives

Rate of normalization of the total alkaline phosphatase level

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)Experimental Treatment6 Interventions

Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leuprolide

FDA approved

Goserelin

FDA approved

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

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