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Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
UNICANCER
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, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate Stage I (T1b or T1c, N0, M0) Stage II (T2, N0, M0) Stage III (T3, N0, M0) Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria: Gleason score at least 7 Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN) T3 OR Good prognosis defined as meeting 1 of the following criteria: T1b or T2 T1c with Gleason score less than 7 and PSA less than 3 times ULN No metastases by bone scans or chest x-ray PATIENT CHARACTERISTICS: Age: 75 and under Performance status: Karnofsky 70-100% Life expectancy: More than 10 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 10 years except basal cell skin cancer No adenopathies PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months No concurrent luteinizing hormone-releasing hormone agonists No concurrent anti-androgen therapy No concurrent hormonal therapy in high-risk group Radiotherapy: No prior pelvic radiotherapy Surgery: No prior lymphadenectomy No prior surgical castration No prior prostatectomy At least 1 month since prior transurethral resection

Sites / Locations

  • Centre Paul Papin
  • Centre Hospitalier d'Annecy
  • Institut Bergonie
  • Centre Regional Francois Baclesse
  • Centre de Radiotherapie du Parc
  • Centre Hospitalier Universitaire Henri Mondor
  • Centre Oscar Lambret
  • Centre Hospital Regional Universitaire de Limoges
  • Clinique de la Sauvegarde - Clinique Jeanne D'Arc
  • Clinique de la Sauvegarde
  • Centre Leon Berard
  • Institut J. Paoli and I. Calmettes
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • CHR D'Orleans - Hopital de la Source
  • Hopital d'Instruction des Armees du Val de Grace
  • Centre Hospitalier Lyon Sud
  • Institut Jean Godinot
  • Centre Eugene Marquis
  • CHG Roanne
  • Clinique de l'Orangerie
  • Centre Paul Strauss
  • Institut Claudius Regaud
  • Centre Marie Curie

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 22, 2016
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00003607
Brief Title
Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
Official Title
Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UNICANCER

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.
Detailed Description
OBJECTIVES: Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis. Compare the toxic effects of these two regimens in these patients. Compare the quality of life of patients treated with these regimens. Determine the prognostic factors of progression in these patients. Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis). Patients are randomized to one of two treatment arms. Arm I: Patients receive pelvic irradiation plus local prostate irradiation. Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks. Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter. Patients are followed at 2 and 6 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 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, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate Stage I (T1b or T1c, N0, M0) Stage II (T2, N0, M0) Stage III (T3, N0, M0) Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria: Gleason score at least 7 Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN) T3 OR Good prognosis defined as meeting 1 of the following criteria: T1b or T2 T1c with Gleason score less than 7 and PSA less than 3 times ULN No metastases by bone scans or chest x-ray PATIENT CHARACTERISTICS: Age: 75 and under Performance status: Karnofsky 70-100% Life expectancy: More than 10 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 10 years except basal cell skin cancer No adenopathies PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months No concurrent luteinizing hormone-releasing hormone agonists No concurrent anti-androgen therapy No concurrent hormonal therapy in high-risk group Radiotherapy: No prior pelvic radiotherapy Surgery: No prior lymphadenectomy No prior surgical castration No prior prostatectomy At least 1 month since prior transurethral resection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Pommier, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Centre Hospitalier d'Annecy
City
Annecy
ZIP/Postal Code
74011 Cedex
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre de Radiotherapie du Parc
City
Chalon Sur Saone
ZIP/Postal Code
71100
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Clinique de la Sauvegarde - Clinique Jeanne D'Arc
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital d'Instruction des Armees du Val de Grace
City
Paris
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
CHG Roanne
City
Roanne
ZIP/Postal Code
F-42300
Country
France
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67010
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Marie Curie
City
Valance
ZIP/Postal Code
26000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18048817
Citation
Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73. doi: 10.1200/JCO.2006.10.5171.
Results Reference
result
Citation
Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005.
Results Reference
result

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Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

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