| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| 7-00 | Other Identifier | Mayo Clinic Cancer Center | |
| 7-00 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant radiation therapy kills tumor cells by placing material such as radioactive iodine directly into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.
OBJECTIVES:
OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration. Patients then undergo interstitial brachytherapy implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.
Quality of life is assessed at baseline and at every treatment and follow-up visit.
After completion of study therapy, patients are followed every 3 months for 2 years, every to 4-6 months for 3 years, and then annually thereafter.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bicalutamide | Drug | |||
| leuprolide acetate | Drug | |||
| adjuvant therapy | Procedure | |||
| neoadjuvant therapy | Procedure | |||
| quality-of-life assessment | Procedure | |||
| brachytherapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | ||
| Patient tolerance | ||
| Toxicities | ||
| Tumor response |
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DISEASE CHARACTERISTICS:
Biopsy-proven adenocarcinoma of the prostate
No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis
Clinical stage T1c-T3a disease at the time of recurrence
PSA < 10 ng/mL
Prostate volume by transrectal ultrasonography < 60 cc
Received prior external beam radiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| William W. Wong, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D016729 | Leuprolide |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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