Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Immune System Diseases

Prostatic Neoplasms

Adenocarcinoma

Neoplasm Metastasis

Hypersensitivity

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Androgens

Hormones

Leuprolide

Goserelin

Bicalutamide

Antineoplastic Agents, Hormonal

Androgen Antagonists

Hormone Antagonists

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.

Goserelin Acetate

Intensity-Modulated Radiation Therapy

Laboratory Biomarker Analysis

Leuprolide Acetate

Cy A Stein

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.

PRIMARY OBJECTIVES:

I. To evaluate the time to prostate-specific antigen (PSA) relapse in patients with oligometastatic (=\< 5 lesions) hormone-sensitive prostate cancer treated with 36 weeks of androgen deprivation therapy and localized radiotherapy to all known tumor sites.

II. To assess the prostate-specific-antigen (PSA) and objective response rate to treatment with 36 weeks of androgen deprivation and localized radiotherapy in patients with oligometastatic hormone-sensitive prostate cancer.

III. To assess the toxicity of 36 weeks of androgen deprivation and localized radiation therapy to oligometastases in patients with oligometastatic hormone-sensitive prostate cancer.

IV. In appropriate situations evaluate the feasibility and toxicities of using helical tomotherapy image-guided intensity-modulated radiation therapy (IMRT) to treat oligometastatic sites.

OUTLINE:

ANDROGEN DEPRIVATION THERAPY (ADT): Patients not currently on ADT receive goserelin acetate subcutaneously (SC) or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide orally (PO) once daily (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.

After completion of study treatment, patients are followed up every 4 weeks for 2 years, then every 3 months after year 2, and then every 6 months thereafter.

Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer

Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to \> 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is \> 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is \> 3.

Number of Patients who achieved PSA nadir of \< 0.2 at 36 weeks.

Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment .

Length of follow-up in weeks to off-study date. Patients are treated for 36 weeks (+/- 2 weeks) with androgen deprivation therapy. Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 264.8 weeks (61.4 months; 5.1 years). Patients will remain off-treatment until they meet the criteria for re-treatment with androgen deprivation therapy, whereupon they will be taken off of the protocol. After patients are taken off protocol, we will do a chart review for long-term outcomes.

Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes.

Length of follow-up of the 8 patients with metastases limited to pelvic lymph nodes, months. Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.

Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes.

National Cancer Institute (NCI)

City of Hope Medical Center

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: Given PO

Goserelin Acetate: Given SC

Intensity-Modulated Radiation Therapy: Undergo IMRT

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given via injection

Treatment (Androgen Therapy, Radiation Therapy)

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

City of Hope National Medical Center, Duarte, CA USA

Region of Enrollment

The number of patients reaching a nadir of PSA \< 0.2 will be reported in the results.

Baseline Prostate Specific Antigen (PSA)

Count of patients with metastases limited to pelvic lymph nodes. This baseline is referenced in the results section.

Metastases limited to pelvic lymph nodes

Dr. Cy Stein

Metastatic prostate cancer patients treated with androgen deprivation.

Time to Prostate-specific Antigen (PSA) Relapse

Patients who achieved PSA nadir of \< 0.2 at 36 weeks.

Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks.

Metastatic prostate cancer patients treated with androgen deprivation therapy.

Spots Global Cancer Trial Database for psa level greater than two