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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00021450
First received: July 13, 2001
Last updated: February 18, 2011
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: goserelin acetate
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]
  • Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]
  • Local control as measured by Gray scale every 6 months until year 5, and annually thereafter [ Designated as safety issue: No ]
  • Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy [ Designated as safety issue: Yes ]
  • Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter [ Designated as 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 [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021450

Locations
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Cyprus
Bank Of Cyprus Oncology Centre
Nicosia, Cyprus, 2006 Strovolos
Czech Republic
Charles University Hospital
Hradec Kralove, Czech Republic, 500 05
France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
Centre Paul Strauss
Strasbourg, France, 67085
Centre d'Oncologie Saint-Yves
Vannes, France, 56001
Ireland
Saint Luke's Hospital
Dublin, Ireland, 6
Italy
Spedali Civili di Brescia
Brescia, Italy, 25124
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Luxembourg
Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette, Luxembourg, L-4240
Netherlands
Arnhems Radiotherapeutisch Instituut
Arnhem, Netherlands, 6815 AD
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Dr. Bernard Verbeeten Instituut
Tilburg, Netherlands, 5042 SB
Poland
Medical University of Gdansk
Gdansk, Poland, 80-211
Spain
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, Spain, 08907
United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
Belfast, Northern Ireland, United Kingdom, BT8 8JR
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Michel Bolla, MD CHU de Grenoble - Hopital de la Tronche
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00021450     History of Changes
Other Study ID Numbers: CDR0000068749, EORTC-22991
Study First Received: July 13, 2001
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Goserelin
Androgen Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014