Hormone Therapy in Treating Patients With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003026
First received: November 1, 1999
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens.

PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: flutamide
Drug: triptorelin
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Estimated Enrollment: 966
Study Start Date: April 1997
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome (overall survival, clinical disease free survival, local regional control), quality of life (treatment side effects, sexual function), and health economy (cost effectiveness ratio).

OUTLINE: This is a randomized, multicenter study.

Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation. Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens. Antiandrogen treatment starts 1 week before the first injection of triptorelin.

Patients are then randomized to one of two treatment arms.

  • Arm I: Patients receive no further treatment.
  • Arm II: Patients receive antiandrogen for 2.5 years plus and LHRH analogue (triptorelin) administered every 3 months. Patients then continue the LHRH analogue alone for an additional 2.5 years in the absence of disease progression.

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

PROJECTED ACCRUAL: A total of 966 patients will be accrued over 5 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • T1c-T2a-b, N1-2 or pN1-2 (after pelvic lymphadenectomy)
    • T2c-T4, N0-2
  • Prior external radiotherapy for locally advanced prostatic carcinoma required
  • Prior hormone therapy (6 months of combined androgen blockade) for locally advanced prostatic carcinoma required with PSA no greater than 150 ng/mL before administration
  • No progressive disease after the 6 months of combined androgen blockage
  • No stages T1c/T2a-b with a negative pelvic lymph nodes status that is assessed clinically or surgically
  • No lymph node involvement to common iliac and/or periaortic lymph nodes (M1a)
  • No external iliac lymph node metastasis more than 5 cm in greatest dimension (N3)
  • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 5 years

Hematopoietic:

  • Hemoglobin at least 10 g/dL
  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No prior or concurrent cancers other than basal cell skin cancer
  • No serious nonmalignant disease resulting in a life expectancy of less than 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for prostate cancer

Chemotherapy

  • No prior chemotherapy for prostate cancer

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics
  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: NCT00003026

Locations
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
Institut Jules Bordet
Brussels (Bruxelles), Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Virga Jesse Hospital
Hasselt, Belgium, 3500
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Israel
Rambam Medical Center
Haifa, Israel, 31096
Malta
St. Luke's Hospital and Medical School
Guardamangia, Malta, MSD 07
Netherlands
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, Netherlands, 5200 ME
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022 GC
Russian Federation
Medical Radiological Research Center
Obninsk, Russian Federation
Turkey
Marmara University Hospital
Istanbul, Turkey, 81190
United Kingdom
City General Hospital
Stoke-On-Trent, England, United Kingdom, ST4 6QG
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Michel Bolla, MD CHU de Grenoble - Hopital de la Tronche
Study Chair: T. M. de Reijke, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Additional Information:
Publications:
Bolla M, van Tienhoven G, de Reijke TM, et al.: Concomitant and adjuvant androgen deprivation (ADT) with external beam irradiation (RT) for locally advanced prostate cancer: 6 months versus 3 years ADT--results of the randomized EORTC phase III trial 22961. [Abstract] J Clin Oncol 25 (Suppl 18): A-5014, 238s, 2007.
Giraud JY, Dusserre A, Conil M, et al.: Results of the dummy-run of EORTC trial no.22961: a phase III study of long term hormonal treatment on locally advanced prostatic carcinoma treated by radiation therapy and a 6 months CAB. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-699, 378, 2001.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003026     History of Changes
Other Study ID Numbers: EORTC-22961, EORTC-22961, EORTC-GU-22961
Study First Received: November 1, 1999
Last Updated: June 29, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Flutamide
Bicalutamide
Triptorelin Pamoate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 20, 2014