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

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ClinicalTrials.gov Identifier: NCT00116220
Recruitment Status : Active, not recruiting
First Posted : June 28, 2005
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
Brigham and Women's Hospital
Saint Anne's Hospital
Beth Israel Deaconess Medical Center
Metro West Medical Center
Information provided by (Responsible Party):
Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Flutamide (Eulexin) and Lupron or Zoladex Radiation: External Beam Radiotherapy Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
Study Start Date : September 1995
Actual Primary Completion Date : April 2001
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Flutamide

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment 1
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
Active Comparator: Treatment 2
External beam radiation therapy
 Radiation: External Beam Radiotherapy
Once a day, 4-5 days per week for approximately 2 months


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy [ Time Frame: Years ]

Eligibility Criteria
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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116220


Locations
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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
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Principal Investigator: Anthony V D'Amico, M.D. Ph.D. Dana-Farber Cancer Institute
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00116220    
Other Study ID Numbers: 95-096
First Posted: June 28, 2005    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Keywords provided by Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute:
Prostate Cancer
Total Androgen Suppression
endorectal coil MRI
External Beam Radiation Therapy
Prostate Cancer- High Risk, clinically Organ-Confined
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Goserelin
 Flutamide
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists