Hormone Therapy in Treating Patients With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003026
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

November 1, 1999
January 27, 2003
July 2, 2012
April 1997
September 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003026 on Archive Site
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Hormone Therapy in Treating Patients With Advanced Prostate Cancer
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

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.


  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Prostate Cancer
  • Drug: bicalutamide
  • Drug: flutamide
  • Drug: triptorelin
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2001   (Final data collection date for primary outcome measure)


  • 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



  • Any age

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 5 years


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


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • No prior biologic therapy for prostate cancer


  • No prior chemotherapy for prostate cancer

Endocrine therapy

  • See Disease Characteristics


  • See Disease Characteristics


  • See Disease Characteristics
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Belgium,   Israel,   Malta,   Netherlands,   Russian Federation,   Turkey,   United Kingdom
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European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
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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)
European Organisation for Research and Treatment of Cancer - EORTC
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP