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A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer


Phase 3
41 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Years

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

95-096

NCT ID:

NCT00116220

Start Date:

September 1995

Completion Date:

April 2014

Related Keywords:

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

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115