Hormone Therapy in Treating Patients With Advanced Prostate Cancer

NCT00003026 | Completed Phase 3

• 2 other identifiers: EORTC-22961EORTC-GU-22961
• Study Type: interventional
• Target: 966
• Locations: 7 countries
• Sites: 17

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate

Interventions

bicalutamide DRUG

flutamide DRUG

triptorelin DRUG

radiation therapy RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (17)

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Virga Jesse Hospital

Hasselt, 3500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

St. Luke's Hospital and Medical School

Guardamangia, MSD 07, Malta

Location

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, 5200 ME, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9700 RB, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Medical Radiological Research Center

Obninsk, Russia

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

City General Hospital

Stoke-on-Trent, England, ST4 6QG, United Kingdom

Location

Related Publications (4)

• Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Pierart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095.

  PMID: 19516032 RESULT

• 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.

  RESULT

• 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.

  RESULT

• King MT, Chen MH, Collette L, Neven A, Bolla M, D'Amico AV. Association of Increased Prostate-Specific Antigen Levels After Treatment and Mortality in Men With Locally Advanced vs Localized Prostate Cancer: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 May 3;4(5):e2111092. doi: 10.1001/jamanetworkopen.2021.11092.

  PMID: 33999161 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Flutamide; Triptorelin Pamoate; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Study Officials

• 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)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 1, 1997
• Primary Completion: September 1, 2001
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

GB (1); RU (1); MA (1); BE (6); NL (6); IL (1); TU (1)