Clinical trial NCT00967863: Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)
Official title: Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2009-08-28
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.

Detailed description: OBJECTIVES:

Primary

* Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer receiving prolonged hormone therapy.

Secondary

* Evaluate overall and specific survival.
* Assess acute and late toxicities of different modalities (conformal or intensity-modulated radiotherapy).
* Evaluate toxicities of the different doses with respect to hormonal therapy.
* Assess the quality of life (QLQ-C30 and PR 25).

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
* Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.

In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3 years.

After completion of study treatment, patients are followed up periodically for 10 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Unfavorable disease, defined by at least 1 of the following criteria:

    * Clinical stage T3 or T4
    * Gleason score ≥8
    * Serum prostate-specific antigen (PSA) ≥20 ng/mL and ≤100 ng/mL
* pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy
* No pelvic lymph nodes ≥15 mm by CT scan or MRI
* No axillary lymph node involvement (pN1)
* No bone metastasis
* Must be starting hormonal treatment on or up to 6 months before beginning radiotherapy

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy \>5 years
* Must be enrolled in a social security program
* No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
* No severe uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg)
* No contraindication to luteinizing hormone-releasing hormone agonists
* No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
* No hip prosthesis
* Must not be deprived of liberty or under guardianship
* No geographical, social, or psychological reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior pelvic irradiation
* At least 3-4 months since prior transurethral resection
* No other prior surgery for prostate cancer
* No concurrent participation in another clinical trial which would require approval upon entry to this trial

Primary outcomes:
measure: Biochemical or clinical progression-free survival at 5 years
timeFrame: 5 years
Secondary outcomes:
measure: Overall and specific survival
timeFrame: 10 years
measure: Acute and late toxicity
timeFrame: 10 years
measure: Quality of life as measured by QLQ-C30 and PR 25 questionnaires
timeFrame: 10 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Centre Francois Baclesse
city: Chambray-lès-Tours
country: France
facility: Clinique Léonard de Vinci
city: Chambéry
country: France
facility: Centre hospitalier Métropole Savoie
city: Créteil
country: France
facility: CHU Henri Mondor
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Hopital La Timone
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier
city: Montpellier
country: France
facility: Centre Val D'Aurelle
city: Mougins
country: France
facility: Centre Azureen de Cancerologie
city: Orléans
country: France
facility: Chr Orleans
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Plérin
country: France
facility: Centre CARIO - HPCA
city: Poitiers
country: France
facility: Hôpital Jean Bernard - CHU de Poitiers
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Herblain
country: France
facility: Centre Rene Gauducheau
city: Saint-Mandé
country: France
facility: Hia Begin
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie LUCIEN NEUWIRTH
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Clinique PASTEUR
city: Tours
country: France
facility: Ch Bretonneau
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Hopital Saint-Louis
name: Christophe HENNEQUIN, PhD
role: PRINCIPAL_INVESTIGATOR
References: