Clinical trial NCT00006359: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Toxicity
timeFrame: q 3 mon for 2 yrs post tx initiation
Secondary outcomes:
measure: Time to PSA failure
timeFrame: 6 years
measure: Survival
timeFrame: 6 years
Other outcomes:
Locations:
city: Lewes
country: United States
facility: Beebe Medical Center
state: Delaware
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Wilmington
country: United States
facility: St. Francis Hospital
state: Delaware
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute at Florida Hospital Orlando
state: Florida
city: Elkton MD
country: United States
facility: Union Hospital Cancer Center at Union Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
state: Massachusetts
city: Fall River
country: United States
facility: Hudner Oncology Center at Saint Anne's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Cancer Center - University Campus
state: Massachusetts
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center at University of Missouri - Columbia
state: Missouri
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Arch Medical Services, Incoroporated at Center for Cancer Care Research
state: Missouri
city: St. Louis
country: United States
facility: Missouri Baptist Cancer Center
state: Missouri
city: Reno
country: United States
facility: Washoe Cancer Services at Washoe Medical Center - Reno
state: Nevada
city: Camden
country: United States
facility: Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Syracuse
country: United States
facility: CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Hospital
state: New York
city: Syracuse
country: United States
facility: Veterans Affairs Medical Center - Syracuse
state: New York
city: Syracuse
country: United States
facility: Community General Hospital of Greater Syracuse
state: New York
city: Charlotte
country: United States
facility: Presbyterian Cancer Center at Presbyterian Hospital
state: North Carolina
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital, Incorporated
state: North Carolina
city: Wilmington
country: United States
facility: Zimmer Cancer Center at New Hanover Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
state: Ohio
city: Danville
country: United States
facility: Danville Regional Medical Center
state: Virginia
Study officials:
affiliation: Dana-Farber/Brigham and Women's Cancer Center
name: Mark Hurwitz, MD
role: STUDY_CHAIR
References:
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.
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.