Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer

This study is ongoing, but not recruiting participants.

First Received: June 27, 2005 Last Updated: December 20, 2007 History of Changes

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Saint Anne's Hospital Beth Israel Deaconess Medical Center Metro West Medical Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00116220

Purpose

This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.

Condition	Intervention	Phase
Prostate Cancer	Drug: Flutamide (Eulexin) and Lupron or Zoladex Radiation: External Beam Radiotherapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

Drug Information available for: Flutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone. [ Time Frame: Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy [ Time Frame: Years ] [ Designated as safety issue: No ]

Enrollment:	270
Study Start Date:	September 1995
Estimated Study Completion Date:	April 2008
Primary Completion Date:	April 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment 1: Active Comparator External beam radiation therapy + 6 months total androgen ablation	Drug: Flutamide (Eulexin) and Lupron or Zoladex Androgen suppression therapy Radiation: External Beam Radiotherapy Once a day, 4-5 days per week for approximately 2 months
Treatment 2: Active Comparator External beam radiation therapy	Radiation: External Beam Radiotherapy Once a day, 4-5 days per week for approximately 2 months

Detailed Description:

This was a randomized study comparing external beam radiation therapy with total androgen ablation for 6 months with radiation therapy alone. Drugs were given 2 months prior, 2 months during, and 2 months after radiation therapy. Eulexin and Lupron or Zoladex was used in this study.

Eligibility

Ages Eligible for Study:	41 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Biopsy proven prostate cancer
Negative bone scan
Lymph nodes by CT or MRI
Adequate blood work
Performance Status - ECOG 0-1
Life expectancy of at least 10 years
>40 years of age

Exclusion Criteria:

Prior history of malignancy
Prior hormonal therapy or chemotherapy
Prior pelvic radiation therapy
Unable to tolerate lying still 5-10 minutes/day

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116220

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Saint Anne's Hospital

Beth Israel Deaconess Medical Center

Metro West Medical Center

Investigators

Principal Investigator:

Anthony V D'Amico, M.D. Ph.D.

Dana-Farber Cancer Institute

More Information

Publications:

D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95.

Responsible Party:	Brigham and Women's Hospital ( Anthony D'Amico, MD, PhD )
Study ID Numbers:	95-096
Study First Received:	June 27, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00116220 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Prostate Cancer
Total Androgen Suppression
endorectal coil MRI
External Beam Radiation Therapy
Prostate Cancer- High Risk, clinically Organ-Confined

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin

Urogenital Neoplasms
Flutamide
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on May 07, 2009