Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00767286

Enrollment

Unknown

Registered

2008-10-07

Start date

Unknown

Completion date

2003-11-30

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Brief summary

RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

Detailed description

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.

Interventions

DRUGflutamide

DRUGgoserelin acetate

RADIATIONlow-LET cobalt-60 gamma ray therapy

RADIATIONlow-LET photon therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026