Clinical trial NCT00104741: Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Official title: Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2005-03-04
Enrollment: 378
Sex: MALE
Minimum age (years): 0
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.

Detailed description: OBJECTIVES:

* Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer.
* Compare the survival rate, in terms of 5-year clinical or biological remission, in patients treated with these regimens.
* Compare overall survival in patients treated with these regimens.
* Compare acute and late toxicity of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.
* Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone.

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

* Arm I: Patients undergo conformal external beam radiotherapy.
* Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily. Androgen blockade therapy continues for a total of 4 months. Two months after initiation of androgen blockade therapy, patients undergo conformal external beam radiotherapy.

Quality of life is assessed.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer, meeting the following clinical staging criteria:

  * Stage T1b-T1c AND prostate specific antigen (PSA) ≥ 10 ng/mL OR Stage T1b-T1c AND Gleason score ≥ 7 OR Stage T2a-T3a
  * No lymph node invasion (N0 or N-)

    * Patients with ≥ 10% risk by the Partin table must undergo curage
  * No metastatic disease (M0) by thoracic radiography and bone scan
* PSA \< 30 ng/mL
* No history of invasive cancer

PATIENT CHARACTERISTICS:

Age

* Under 75

Performance status

* ECOG 0-1

Life expectancy

* At least 10 years

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

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
* No prior castration

Primary outcomes:
measure: Impact of complete androgen blockade for 4 months
measure: Survival, in terms of clinical or biological remission, at 5 years
measure: Overall survival
measure: Acute and late toxicity
measure: Quality of life
measure: Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)
Secondary outcomes:
Other outcomes:
Locations:
city: Ales
country: France
facility: Clinique De Rochebelle
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Colmar
country: France
facility: Hopitaux Civils de Colmar
city: Creteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Creteil
country: France
facility: Hopital Intercommunal De Creteil
city: Epinal
country: France
facility: Hopital Jean Monnet
city: Gap
country: France
facility: Centre Hospitalier Intercommunal des Alpes du Sud
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Marseille
country: France
facility: CHU de la Timone
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Mulhouse
country: France
facility: Centre Hospitalier
city: Nantes
country: France
facility: Centre Regional Rene Gauducheau
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: Clinique De Valdegour
city: Paris
country: France
facility: Hopital d'Instruction des Armees du Val de Grace
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Tenon
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: Centre Hospitalier Universitaire Bretonneau de Tours
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Henri Becquerel
name: Bernard M. Dubray, MD, PhD
role: STUDY_CHAIR
References:
citation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.