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Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
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
ClinicalTrials.gov Identifier:
NCT00116220
First received: June 27, 2005
Last updated: August 1, 2016
Last verified: August 2016
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Flutamide
U.S. FDA Resources
Further study details as provided by Anthony V. D'Amico, MD, PhD, 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 ]
Secondary Outcome Measures:
- Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy [ Time Frame: Years ]
| Enrollment: | 226 |
| Study Start Date: | September 1995 |
| Estimated Study Completion Date: | April 2017 |
| Primary Completion Date: | April 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 (Adult, Senior) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00116220
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00116220 History of Changes |
| Other Study ID Numbers: |
95-096 |
| Study First Received: | June 27, 2005 |
| Last Updated: | August 1, 2016 |
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:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Goserelin Flutamide |
Androgens Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Hormones |
ClinicalTrials.gov processed this record on June 27, 2017