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Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00684905
First received: May 14, 2008
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: bicalutamide
Drug: leuprolide acetate
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Radiation: brachytherapy
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • Patient tolerance [ Designated as safety issue: Yes ]
  • Toxicities [ Designated as safety issue: Yes ]
  • Tumor response [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2000
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior external-beam irradiation.
  • Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
  • Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Biopsy-proven adenocarcinoma of the prostate

    • Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA)
  • 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:

  • ECOG performance status 0-2
  • WBC ≥ 3,000/μL
  • Platelet count ≥ 90,000/μL
  • Hemoglobin ≥ 10 g/dL
  • Alkaline phosphatase < 2 times normal
  • AST < 2 times normal
  • Normal prothrombin time and partial thromboplastin time
  • No significant obstructive urinary symptoms (AUA score ≤ 16)
  • No contraindication for general anesthesia

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior transurethral resection of the prostate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684905

Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: William W. Wong, MD Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: William Wailing Wong, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00684905     History of Changes
Obsolete Identifiers: NCT00956995
Other Study ID Numbers: 07-00, P30CA015083, 7-00, 7-00
Study First Received: May 14, 2008
Last Updated: November 9, 2012
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Bicalutamide
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013