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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

bicalutamide

leuprolide acetate

adjuvant therapy

neoadjuvant therapy

quality-of-life assessment

brachytherapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Arizona

Outcomes

Primary Outcome Measures

Feasibility

Patient tolerance

Toxicities

Tumor response

Secondary Outcome Measures

Full Information

NCT ID

NCT00684905

First Posted

May 14, 2008

Last Updated

November 9, 2012

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00684905

Brief Title

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

Official Title

Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

April 2000 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

bicalutamide

Intervention Type

Drug

Intervention Name(s)

leuprolide acetate

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Intervention Type

Radiation

Intervention Name(s)

brachytherapy

Primary Outcome Measure Information:

Title

Feasibility

Title

Patient tolerance

Title

Toxicities

Title

Tumor response

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William W. Wong, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Mayo Clinic in Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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