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Hormone Therapy in Treating Patients With Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bicalutamide
flutamide
triptorelin
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet
  • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent
  • Virga Jesse Hospital
  • U.Z. Gasthuisberg
  • Rambam Medical Center
  • St. Luke's Hospital and Medical School
  • Groot Ziekengasthuis 's-Hertogenbosch
  • Onze Lieve Vrouwe Gasthuis
  • Academisch Medisch Centrum
  • Academisch Ziekenhuis Groningen
  • Academisch Ziekenhuis Maastricht
  • St. Elisabeth Ziekenhuis
  • Medical Radiological Research Center
  • Marmara University Hospital
  • City General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 29, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00003026
Brief Title
Hormone Therapy in Treating Patients With Advanced Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
September 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
966 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Type
Drug
Intervention Name(s)
flutamide
Intervention Type
Drug
Intervention Name(s)
triptorelin
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Bolla, MD
Organizational Affiliation
CHU de Grenoble - Hopital de la Tronche
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
T. M. de Reijke, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels (Bruxelles)
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Virga Jesse Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
St. Luke's Hospital and Medical School
City
Guardamangia
ZIP/Postal Code
MSD 07
Country
Malta
Facility Name
Groot Ziekengasthuis 's-Hertogenbosch
City
's-Hertogenbosch
ZIP/Postal Code
5200 ME
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
St. Elisabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Medical Radiological Research Center
City
Obninsk
Country
Russian Federation
Facility Name
Marmara University Hospital
City
Istanbul
ZIP/Postal Code
81190
Country
Turkey
Facility Name
City General Hospital
City
Stoke-On-Trent
State/Province
England
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19516032
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
33999161
Citation
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.
Results Reference
derived

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Hormone Therapy in Treating Patients With Advanced Prostate Cancer

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