Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00116220 |
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Recruitment Status
:
Active, not recruiting
First Posted
: June 28, 2005
Last Update Posted
: July 26, 2017
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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
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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 |
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 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 : | September 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Treatment 1
External beam radiation therapy + 6 months total androgen ablation
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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
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Active Comparator: Treatment 2
External beam radiation therapy
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Radiation: External Beam Radiotherapy
Once a day, 4-5 days per week for approximately 2 months
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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 ]
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| 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
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
| 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 |
Publications of Results:
Other 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 |
| First Posted: | June 28, 2005 Key Record Dates |
| Last Update Posted: | July 26, 2017 |
| Last Verified: | July 2017 |
Keywords provided by Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute:
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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 Genital Diseases, Male Prostatic Diseases Androgens Goserelin |
Flutamide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists |