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

NCT ID: NCT00767286

Last Updated: 2014-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2003-11-30

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

flutamide

Intervention Type: DRUG

goserelin acetate

Intervention Type: DRUG

low-LET cobalt-60 gamma ray therapy

Intervention Type: RADIATION

low-LET photon therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Gerald E. Hanks, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

References

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Other Identifiers

RTOG-9202

Identifier Type: -

Identifier Source: secondary_id

CDR0000077690

Identifier Type: -

Identifier Source: org_study_id