Clinical trial NCT00003607: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 450
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Annecy
country: France
facility: Centre Hospitalier d'Annecy
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Chalon Sur Saone
country: France
facility: Centre de Radiotherapie du Parc
city: Creteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
city: Lyon
country: France
facility: Clinique de la Sauvegarde - Clinique Jeanne D'Arc
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut J. Paoli and I. Calmettes
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Orleans
country: France
facility: CHR D'Orleans - Hopital de la Source
city: Paris
country: France
facility: Hopital d'Instruction des Armees du Val de Grace
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Roanne
country: France
facility: CHG Roanne
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Valance
country: France
facility: Centre Marie Curie
Study officials:
affiliation: Centre Leon Berard
name: Pascal Pommier, MD
role: STUDY_CHAIR
References:
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.
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.