Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	80 and under	Other	EORTC-22991 NCT00021450

Objectives

1. 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.
2. Compare the acute and late radiation-induced side effects of these regimens in these patients.
3. Compare the biochemical/clinical disease-free survival, overall survival, and time to local progression in patients treated with these regimens.
4. Compare the time to clinical biological failure or death in patients treated with these regimens.
5. Compare the quality of life of patients treated with these regimens.

Entry Criteria

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

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

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

Expected Enrollment

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

Outcomes

Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter

Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter
Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter
Local control as measured by Gray scale every 6 months until year 5, and annually thereafter
Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy
Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter
Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter

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.

Matzinger O, Duclos F, Bergh AV, et al.: Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991. Eur J Cancer : , 2009.[PUBMED Abstract]

Matzinger O, Poortmans P, Giraud JY, et al.: Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: dummy run and individual case review. Radiother Oncol 90 (3): 285-90, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Michel Bolla, MD, Study coordinator		Ph: 33-476-765-506 Email: mbolla@chu-grenoble.fr

Registry Information
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
Trial Start Date		2001-04-26
Registered in ClinicalTrials.gov		NCT00021450
Date Submitted to PDQ		2001-06-11
Information Last Verified		2008-04-13

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