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NCT Number: NCT00021450

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

Up to 80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bicalutamide

Drug

Goserelin acetate

Drug

adjuvant therapy

Procedure

radiation therapy

Radiation

Primary outcomes

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

Secondary outcomes

  1. Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter

  2. Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter

  3. Local control as measured by Gray scale every 6 months until year 5, and annually thereafter

  4. Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy

  5. Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter

  6. Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2008
Study completion
2016
First posted
Jan 27, 2003
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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