Hormone Therapy in Treating Patients With Advanced Prostate Cancer - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003026

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 III

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

Drug Information available for: Flutamide Triptorelin Bicalutamide Triptorelin pamoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

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

Estimated Enrollment:	966
Study Start Date:	April 1997

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

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
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Virga Jesse Hospital
Hasselt, Belgium, 3500
Israel
Rambam Medical Center
Haifa, Israel, 31096
Malta
St. Luke's Hospital and Medical School
Guardamangia, Malta, MSD 07
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, Netherlands, 5200 ME
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
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, England
City General Hospital
Stoke-On-Trent, England, United Kingdom, ST4 6QG

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	CDR0000065616, EORTC-22961, EORTC-GU-22961
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003026 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Contraceptive Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Adjuvants, Immunologic
Urogenital Neoplasms
Genital Diseases, Male

Flutamide
Hormones
Carcinoma
Androgen Antagonists
Triptorelin
Bicalutamide
Adenocarcinoma
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Contraceptive Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Urogenital Neoplasms
Reproductive Control Agents

Genital Diseases, Male
Luteolytic Agents
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Neoplasms by Site
Triptorelin
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009