A PHASE III TRIAL OF THE USE OF LONG TERM TOTAL ANDROGEN SUPPRESSION FOLLOWING NEOADJUVANT HORMONAL CYTOREDUCTION AND RADIOTHERAPY IN LOCALLY ADVANCED CARCINOMA OF THE PROSTATE
50 Years
N/A
Male
Prostate Cancer
Trial Information
A PHASE III TRIAL OF THE USE OF LONG TERM TOTAL ANDROGEN SUPPRESSION FOLLOWING NEOADJUVANT HORMONAL CYTOREDUCTION AND RADIOTHERAPY IN LOCALLY ADVANCED CARCINOMA OF THE PROSTATE
OBJECTIVES: I. Compare locoregional control, disease-free survival, and overall survival in
patients with carcinoma of the prostate who are considered at high risk of relapse and
receive long-term adjuvant zoladex (ZDX) vs. no adjuvant treatment following neoadjuvant
ZDX/flutamide and radiotherapy. II. Compare sexual function in patients treated with these
two regimens.
OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy and Releasing Factor
Agonist Therapy plus Radiotherapy. Flutamide, FLUT, NSC-147834; and Zoladex, ZDX,
NSC-606864; plus external-beam irradiation using megavoltage equipment with energies of at
least 4 MV (at least 6 MV preferred). Arm II: Neoadjuvant Antiandrogen Therapy and Releasing
Factor Agonist Therapy plus Radiotherapy followed by Adjuvant Releasing Factor Agonist
Therapy. FLUT; and ZDX; plus external-beam irradiation using equipment as in Arm I; followed
by ZDX.
PROJECTED ACCRUAL: 1,508 patients will be accrued over 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, locally advanced adenocarcinoma of the
prostate, including: Bulky primary tumors confined to the prostate (clinical Stage T2c)
Primary tumors extending beyond the capsule (clinical Stage T3-4) No common iliac or
para-aortic nodal involvement Regional lymph node involvement below the common iliac level
allowed Positive nodes on imaging studies must be biopsied by FNA or surgical sampling PSA
no more than 150 (mandatory) No distant metastases
PATIENT CHARACTERISTICS: Age: At least 50 Performance status: Karnofsky 70-100%
Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior
or concurrent second cancer except basal cell skin cancer No major medical or psychiatric
illness that would prevent completion of treatment or interfere with follow-up
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: No prior hormonal therapy Radiotherapy: No prior
radiotherapy Surgery: No prior radical surgery for carcinoma of the prostate
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Gerald E. Hanks, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000077690
NCT ID:
NCT00767286
Start Date:
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|
