Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
N/A
N/A
Male
Prostate Cancer
Trial Information
Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer
OBJECTIVES:
- Assess the disease free survival of patients with localized adenocarcinoma of the
prostate cancer.
- Evaluate the toxic effects of three dimensional conformal external beam radiotherapy
and androgen deprivation in these patients.
OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus
class III/IV).
Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid.
Patients are evaluated on a monthly basis for response. Patients with unchanged or
undetectable prostate specific antigen levels are considered to have reached maximal
hormonal response and three dimensional conformal external beam radiotherapy is instituted.
In addition, patients with disease progression are considered to have reached maximal
response, and three dimensional conformal external beam radiotherapy is instituted.
Radiotherapy must be administered within 6 months after initiation of leuprolide and
flutamide therapy.
Hormonal therapy is administered until 9 months of treatment have elapsed.
Patients will be followed every 3 months for the first year, every 4 months for the second
and third years, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3
years, and 58 patients from biologic class III-IV.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven localized adenocarcinoma of the prostate
- Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if
PSA is no greater than 4
- CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater
than 50
- Negative pelvic lymphadenectomy, if PSA is greater than 50
- Bone scan negative for metastases or PSA no greater than 20
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance Status:
- Not specified
Life Expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 70,000/mm3
- Hemoglobin at least 10 g/dL
- Patients on anticoagulant therapy must have a baseline PT test
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- ALT or AST less than 1.5 times ULN
- Alkaline phosphatase less than 1.5 times ULN
Renal:
- Creatinine less than 1.5 times ULN
Cardiovascular:
- No history of collagen vascular disease
Other:
- No acute infection requiring antibiotics
- No history of hypersensitivity to flutamide
- No history of hypersensitivity to leuprolide acetate
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Ronald D. Ennis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Herbert Irving Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000065883
NCT ID:
NCT00003124
Start Date:
May 1997
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
