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Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LHRH agonist
antiandrogen
radiation therapy
Brachytherapy boost
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Must have one of the following prognostic factors: Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score > 6 Stage T1-2, N0; PSA > 10 ng/mL and < 20 ng/mL; and Gleason score ≤ 6 Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6 Prostate volume < 60 cc by transrectal ultrasound No distant or nodal metastases No metastatic disease by bone scan, CT scan, or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic: Bilirubin ≤ 1.5 times upper limit of normal Renal: Not specified Other: Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for prostate cancer Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy No other prior hormonal therapy Radiotherapy: No prior radiotherapy for prostate cancer Surgery: No prior surgery for prostate cancer No prior transurethral resection of the prostate Other: No prior alternative therapy (e.g., PC-SPES) for prostate cancer

Sites / Locations

  • Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • St. Francis Hospital
  • Florida Hospital Cancer Institute at Florida Hospital Orlando
  • Union Hospital Cancer Center at Union Hospital
  • Brigham and Women's Hospital
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Hudner Oncology Center at Saint Anne's Hospital
  • UMASS Memorial Cancer Center - University Campus
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • Arch Medical Services, Incoroporated at Center for Cancer Care Research
  • Missouri Baptist Cancer Center
  • Washoe Cancer Services at Washoe Medical Center - Reno
  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
  • Roswell Park Cancer Institute
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • SUNY Upstate Medical University Hospital
  • Veterans Affairs Medical Center - Syracuse
  • Community General Hospital of Greater Syracuse
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Wayne Memorial Hospital, Incorporated
  • Zimmer Cancer Center at New Hanover Regional Medical Center
  • Comprehensive Cancer Center at Wake Forest University
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • Danville Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Androgen suppression + EBRT + Brachytherapy

Arm Description

Androgen suppression with external beam radiation therapy followed by brachytherapy boost

Outcomes

Primary Outcome Measures

Toxicity

Secondary Outcome Measures

Time to PSA failure
Survival
Progression free and overall survival will be assessed

Full Information

First Posted
October 4, 2000
Last Updated
July 15, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006359
Brief Title
Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
Official Title
Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
Detailed Description
OBJECTIVES: Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer. Determine the safety of EBRT+BT in these patients. Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients. OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks. Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds. Patients are followed every 3 months for 2 years and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

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, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Androgen suppression + EBRT + Brachytherapy
Arm Type
Experimental
Arm Description
Androgen suppression with external beam radiation therapy followed by brachytherapy boost
Intervention Type
Drug
Intervention Name(s)
LHRH agonist
Intervention Description
Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
Intervention Type
Drug
Intervention Name(s)
antiandrogen
Intervention Description
flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy boost
Intervention Description
Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
Primary Outcome Measure Information:
Title
Toxicity
Time Frame
q 3 mon for 2 yrs post tx initiation
Secondary Outcome Measure Information:
Title
Time to PSA failure
Time Frame
6 years
Title
Survival
Description
Progression free and overall survival will be assessed
Time Frame
6 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Must have one of the following prognostic factors: Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score > 6 Stage T1-2, N0; PSA > 10 ng/mL and < 20 ng/mL; and Gleason score ≤ 6 Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6 Prostate volume < 60 cc by transrectal ultrasound No distant or nodal metastases No metastatic disease by bone scan, CT scan, or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic: Bilirubin ≤ 1.5 times upper limit of normal Renal: Not specified Other: Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for prostate cancer Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy No other prior hormonal therapy Radiotherapy: No prior radiotherapy for prostate cancer Surgery: No prior surgery for prostate cancer No prior transurethral resection of the prostate Other: No prior alternative therapy (e.g., PC-SPES) for prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hurwitz, MD
Organizational Affiliation
Dana-Farber/Brigham and Women's Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
St. Francis Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
Facility Name
Florida Hospital Cancer Institute at Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Union Hospital Cancer Center at Union Hospital
City
Elkton MD
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hudner Oncology Center at Saint Anne's Hospital
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
UMASS Memorial Cancer Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Arch Medical Services, Incoroporated at Center for Cancer Care Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Washoe Cancer Services at Washoe Medical Center - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Community General Hospital of Greater Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Zimmer Cancer Center at New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Hurwitz MD, Halabi S, Archer L, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-192, 2010.
Results Reference
result
PubMed Identifier
18407435
Citation
Hurwitz MD, Halabi S, Ou SS, McGinnis LS, Keuttel MR, Dibiase SJ, Small EJ. Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: an initial report of CALGB 99809. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):814-9. doi: 10.1016/j.ijrobp.2008.01.010. Epub 2008 Apr 11.
Results Reference
result

Learn more about this trial

Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

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