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Prostate CancerPhase 3NCT00021450

Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

A Phase 3 study testing bicalutamide, goserelin acetate and adjuvant therapy in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 20 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer. Read more about this study

Who is it for?
Ages Up to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bicalutamide, goserelin acetate and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
819 participants
Where
20 sitesin 11 countries
Study dates
Apr 2001to Jan 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 80 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage II prostate cancer
  • T1b-c, N0, M0 with prostate-specific antigen (PSA) at least 10 ng/mL and/or Gleason score at least 7 (UICC 1997 classification) OR
  • T2a, N0, M0 (UICC 1997 classification)
  • Serum PSA no greater than 50 ng/mL
  • No involvement of pelvic lymph nodes

PATIENT CHARACTERISTICS:

Age:

  • 80 and under

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other malignancy within the past 5 years except adequately treated basal cell skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No prior hormonal therapy

Radiotherapy:

  • No prior pelvic radiotherapy

Surgery:

  • No prior radical prostatectomy

Trial locations and contacts

20 sites in 11 countries.

20 sites in 11 countries

France5 sites

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Centre Paul Strauss

    Strasbourg, 67085

  • Centre d'Oncologie Saint-Yves

    Vannes, 56001

Other trials in France

Belgium3 sites

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Netherlands3 sites

  • Arnhems Radiotherapeutisch Instituut

    Arnhem, 6815 AD

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Dr. Bernard Verbeeten Instituut

    Tilburg, 5042 SB

Other trials in Netherlands

Italy2 sites

  • Spedali Civili di Brescia

    Brescia, 25124

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa, 16132

Other trials in Italy

Cyprus1 site

  • Bank Of Cyprus Oncology Centre

    Nicosia, 2006 Strovolos

Other trials in Cyprus

Czechia1 site

  • Charles University Hospital

    Hradec Králové, 500 05

Other trials in Czechia

Ireland1 site

  • Saint Luke's Hospital

    Dublin, 6

Other trials in Ireland

Luxembourg1 site

  • Hopital de la Ville D'Esch-sur-Alzette

    Esch-sur-Alzette, L-4240

Other trials in Luxembourg

Poland1 site

  • Medical University of Gdansk

    Gdansk, 80-211

Other trials in Poland

Spain1 site

  • Institut Catala d'Oncologia - Hospital Duran i Reynals

    Barcelona, 08907

Other trials in Spain

United Kingdom1 site

  • Belfast City Hospital Trust Incorporating Belvoir Park Hospital

    Belfast, Northern Ireland, BT8 8JR

Other trials in United Kingdom

About this study

Official title: Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer.

Read the detailed description

OBJECTIVES:

  • Compare the potential beneficial impact of radiotherapy with or without adjuvant bicalutamide and goserelin on the long-term outcome of patients with localized prostate cancer.
  • Compare the acute and late radiation-induced side effects of these regimens in these patients.
  • Compare the biochemical/clinical disease-free survival, overall survival, and time to local progression in patients treated with these regimens.
  • Compare the time to clinical biological failure or death in patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for 7-7.5 weeks.
  • Arm II: Patients receive adjuvant oral bicalutamide once daily on days 1-30 and goserelin subcutaneously on days 8 and 98. Beginning on day 8, patients undergo radiotherapy as in arm I.

Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 5 years.

Conditions
Prostate Cancer
Being tested
bicalutamide, goserelin acetate, adjuvant therapy, radiation therapy
Keywords
stage IIB prostate cancer, stage IIA prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bicalutamideDrug

  • goserelin acetateDrug

  • adjuvant therapyProcedure or surgery

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter

Secondary outcomes (6)

  1. Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter

  2. Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter

  3. Local control as measured by Gray scale every 6 months until year 5, and annually thereafter

  4. Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy

  5. Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter

  6. Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2001
  3. Primary completionApr 2008
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
819 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00021450
Sponsor's protocol ID
EORTC-22991
Other IDs
EORTC-22991
Status last verified
Sep 2016
First submitted
13 Jul 2001
Last updated
2 Sep 2016
Results posted
No

Publications

  • Matzinger O, Poortmans P, Giraud JY, Maingon P, Budiharto T, van den Bergh AC, Davis JB, Musat E, Ataman F, Huyskens DP, Gulyban A, Bolla M; EORTC Radiation Oncology Group. Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: dummy run and individual case review. Radiother Oncol. 2009 Mar;90(3):285-90. doi: 10.1016/j.radonc.2008.10.022. Epub 2008 Nov 27.

    PubMed 19038468

  • Matzinger O, Duclos F, van den Bergh A, Carrie C, Villa S, Kitsios P, Poortmans P, Sundar S, van der Steen-Banasik EM, Gulyban A, Collette L, Bolla M; EORTC Radiation Oncology Group. Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991. Eur J Cancer. 2009 Nov;45(16):2825-34. doi: 10.1016/j.ejca.2009.07.009. Epub 2009 Aug 12.

    PubMed 19682889

  • Bolla M, Neven A, Maingon P, Carrie C, Boladeras A, Andreopoulos D, Engelen A, Sundar S, van der Steen-Banasik EM, Armstrong J, Peignaux-Casasnovas K, Boustani J, Herrera FG, Pieters BR, Slot A, Bahl A, Scrase CD, Azria D, Jansa J, O'Sullivan JM, Van Den Bergh ACM, Collette L; EORTC Radiation Oncology Group. Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease. J Clin Oncol. 2021 Sep 20;39(27):3022-3033. doi: 10.1200/JCO.21.00855. Epub 2021 Jul 26.

    PubMed 34310202

  • Bolla M, Maingon P, Carrie C, Villa S, Kitsios P, Poortmans PM, Sundar S, van der Steen-Banasik EM, Armstrong J, Bosset JF, Herrera FG, Pieters B, Slot A, Bahl A, Ben-Yosef R, Boehmer D, Scrase C, Renard L, Shash E, Coens C, van den Bergh AC, Collette L. Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer: Results of EORTC Trial 22991. J Clin Oncol. 2016 May 20;34(15):1748-56. doi: 10.1200/JCO.2015.64.8055. Epub 2016 Mar 14.

    PubMed 26976418

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bicalutamide, goserelin acetate and adjuvant therapy in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 20 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France, Belgium, Netherlands, Italy, Cyprus and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00021450, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.

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