Hormone Therapy in Treating Patients With Advanced Prostate Cancer
NCT ID: NCT00003026
Last Updated: 2012-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
966 participants
INTERVENTIONAL
1997-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer
NCT00003734
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
NCT00002633
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
NCT00004054
Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
NCT00023829
Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
NCT00104741
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bicalutamide
flutamide
triptorelin
radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michel Bolla, MD
Role: STUDY_CHAIR
CHU de Grenoble - Hopital de la Tronche
T. M. de Reijke, MD, PhD
Role: STUDY_CHAIR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , Belgium
Institut Jules Bordet
Brussels (Bruxelles), , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Virga Jesse Hospital
Hasselt, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Rambam Medical Center
Haifa, , Israel
St. Luke's Hospital and Medical School
Guardamangia, , Malta
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
St. Elisabeth Ziekenhuis
Tilburg, , Netherlands
Medical Radiological Research Center
Obninsk, , Russia
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
City General Hospital
Stoke-on-Trent, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-22961
Identifier Type: -
Identifier Source: secondary_id
EORTC-GU-22961
Identifier Type: -
Identifier Source: secondary_id
EORTC-22961
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.