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

Recruiting in Palo Alto (17 mi)

Dr. Savita Dandapani, MD – Duarte, CA ...

Overseen bySavita Dandapani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body radiation in treating patients with prostate cancer that has spread to other places in the body. Radium Ra 223 dichloride contains a radioactive substance that collects in the bone and gives off radiation that may kill cancer cells. Hormone therapy using leuprolide acetate or goserelin acetate may fight prostate cancer by lowering the amount of testosterone the body makes. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving radium Ra 223 dichloride, hormone therapy and stereotactic body radiation may work better at treating prostate cancer.

Eligibility Criteria

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.

Inclusion Criteria

Aspartate aminotransferase (AST) =< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)

Platelets >= 100,000/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy)

Total serum bilirubin =< 2 x upper limit of normal (ULN) (to be performed within 14 days prior to day 1 of protocol therapy)

+32 more

Exclusion Criteria

I have previously received radium Ra 223 treatment.

I have or am receiving chemotherapy for cancer that has returned or spread, with some exceptions.

I am receiving radiation therapy targeted at my prostate.

+10 more

Participant Groups

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.

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.

Goserelin Acetate is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Zoladex for: