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Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer


Phase 2
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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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 CenterNew York, New York  10032