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 :
Completed
First Posted : June 28, 2005
Last Update Posted : January 6, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: Flutamide (Eulexin) and Lupron or Zoladex Radiation: External Beam Radiotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 206 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 |
Actual Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
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 |
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 |
- 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 ]
- 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, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Anthony V D'Amico, M.D. Ph.D. | Dana-Farber Cancer Institute |
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 |
Other Study ID Numbers: |
95-096 |
First Posted: | June 28, 2005 Key Record Dates |
Last Update Posted: | January 6, 2022 |
Last Verified: | December 2021 |
Prostate Cancer Total Androgen Suppression endorectal coil MRI External Beam Radiation Therapy Prostate Cancer- High Risk, clinically Organ-Confined |
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 |