Official Title: “Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study”

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer.

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control

OBJECTIVES: - Compare the potential beneficial impact of radiotherapy with or without adjuvant bicalutamide and goserelin on the long-term outcome of patients with localized prostate cancer. - Compare the acute and late radiation-induced side effects of these regimens in these patients. - Compare the biochemical/clinical disease-free survival, overall survival, and time to local progression in patients treated with these regimens. - Compare the time to clinical biological failure or death in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for 7-7.5 weeks. - Arm II: Patients receive adjuvant oral bicalutamide once daily on days 1-30 and goserelin subcutaneously on days 8 and 98. Beginning on day 8, patients undergo radiotherapy as in arm I.

Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 5 years.

Intervention(s) in this Clinical Trial

• Drug: bicalutamide
• Drug: goserelin
• Procedure: adjuvant therapy
• Procedure: radiation therapy

Primary Measures

• Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter
  • Safety Issue?: No

Secondary Measures

• Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter
  • Safety Issue?: No
• Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter
  • Safety Issue?: No
• Local control as measured by Gray scale every 6 months until year 5, and annually thereafter
  • Safety Issue?: No
• Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy
  • Safety Issue?: Yes
• Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter
  • Safety Issue?: Yes
• Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II prostate cancer
• T1b-c, N0, M0 with prostate-specific antigen (PSA) at least 10 ng/mL and/or
• Gleason score at least 7 (UICC 1997 classification) OR
• T2a, N0, M0 (UICC 1997 classification)
• Serum PSA no greater than 50 ng/mL
• No involvement of pelvic lymph nodes

PATIENT CHARACTERISTICS:

Age:

• 80 and under

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other malignancy within the past 5 years except adequately treated basal cell skin cancer
• No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No prior hormonal therapy

Radiotherapy:

• No prior pelvic radiotherapy

Surgery:

• No prior radical prostatectomy

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: European Organization for Research and Treatment of Cancer

Overall Clinical Trial Officials and Contacts

Michel Bolla, MD  CHU de Grenoble - Hopital de la Tronche  

Information obtained from ClinicalTrials.gov on January 06, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00021450

Study ID Number: CDR0000068749

ClinicalTrials.gov Identifier: NCT00021450

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database