Hormone + Radiation Therapy for Metastatic Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byCy A Stein

Age: 18+

Sex: Male

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 II trial studies how well hormone therapy and intensity-modulated radiation therapy work in treating patients with prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy using goserelin, leuprolide acetate, or bicalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving hormone therapy and intensity-modulated radiation therapy may work better in treating patients with prostate cancer.

Research Team

Cy A Stein

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for men with metastatic prostate cancer who haven't had prior radiation for metastasis, have a good performance status (WHO 0-2), and have limited number of lesions. They should not have brain metastases or severe medical conditions, no history of orchiectomy, and must not be refractory to hormone therapy.

Inclusion Criteria

I may have had hormone therapy for up to 36 weeks before joining this study.

I have not had radiation for cancer that has spread.

I understand the trial's nature and can give my written consent.

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Exclusion Criteria

I do not have any severe ongoing health issues or uncontrolled infections.

I have had surgery to remove one or both of my testicles.

Patients undergoing therapy with other investigational agents

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Treatment Details

Interventions

Bicalutamide (Hormone Therapy)
Goserelin Acetate (Hormone Therapy)
Intensity-Modulated Radiation Therapy (Radiation)
Leuprolide Acetate (Hormone Therapy)

Trial OverviewThe study tests if combining hormone therapy (goserelin, leuprolide acetate, bicalutamide) with targeted high-dose radiation (intensity-modulated radiation therapy) can better treat prostate cancer that has spread compared to standard treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (androgen therapy, radiation therapy)Experimental Treatment5 Interventions

ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.

Bicalutamide is already approved in Japan, Canada for the following indications: