Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

NCT00006359 | Completed Phase 2

• 3 other identifiers: CALGB-99809U10CA031946CDR0000068228
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 26

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity

  q 3 mon for 2 yrs post tx initiation

Secondary Outcomes (2)

• Time to PSA failure

  6 years

• Survival

  6 years

Study Arms (1)

Androgen suppression + EBRT + Brachytherapy

EXPERIMENTAL

Androgen suppression with external beam radiation therapy followed by brachytherapy boost

Drug: LHRH agonist; Drug: antiandrogen; Radiation: radiation therapy; Radiation: Brachytherapy boost

Interventions

LHRH agonist DRUG

Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2

Androgen suppression + EBRT + Brachytherapy

antiandrogen DRUG

flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks

Androgen suppression + EBRT + Brachytherapy

radiation therapy RADIATION

4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)

Androgen suppression + EBRT + Brachytherapy

Brachytherapy boost RADIATION

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

Androgen suppression + EBRT + Brachytherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (26)

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

St. Francis Hospital

Wilmington, Delaware, 19805, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

Union Hospital Cancer Center at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Hudner Oncology Center at Saint Anne's Hospital

Fall River, Massachusetts, 02721, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

Arch Medical Services, Incoroporated at Center for Cancer Care Research

St Louis, Missouri, 63141, United States

Location

Washoe Cancer Services at Washoe Medical Center - Reno

Reno, Nevada, 89502, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

Camden, New Jersey, 08103, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13057, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

Community General Hospital of Greater Syracuse

Syracuse, New York, 13215, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Zimmer Cancer Center at New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Related Publications (2)

• 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.

  RESULT

• 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.

  PMID: 18407435 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone; Androgen Antagonists; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics

Study Officials

• Mark Hurwitz, MD

  Dana-Farber/Brigham and Women's Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2000
• First Posted: January 27, 2003
• Study Start: September 1, 2000
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2012
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

US (26)