Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104741
• Other study ID #: UC-0160/0207
• Secondary ID: FRE-FNCLCC-GETUG
• Status: Completed
• Phase: Phase 3
• Start date: September 10, 2003
• Est. completion date: October 15, 2015

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: October 15, 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• flutamide

• triptorelin

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Clinique De Rochebelle	Ales
France	Institut Sainte Catherine	Avignon
France	Hopital Louis Pasteur	Colmar
France	Hopitaux Civils de Colmar	Colmar
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Hopital Intercommunal De Creteil	Creteil
France	Hopital Jean Monnet	Epinal
France	Centre Hospitalier Intercommunal des Alpes du Sud	Gap
France	Centre Oscar Lambret	Lille
France	Centre Hospital Regional Universitaire de Limoges	Limoges
France	Centre Leon Berard	Lyon
France	CHU de la Timone	Marseille
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Centre Hospitalier	Mulhouse
France	Centre Hospitalier de Mulhouse	Mulhouse
France	Centre Regional Rene Gauducheau	Nantes
France	Centre Antoine Lacassagne	Nice
France	Clinique De Valdegour	Nimes
France	CHU Pitie-Salpetriere	Paris
France	Hopital d'Instruction des Armees du Val de Grace	Paris
France	Hopital Saint-Louis	Paris
France	Hopital Tenon	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU Poitiers	Poitiers
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Institut Claudius Regaud	Toulouse
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of complete androgen blockade for 4 months
Primary	Survival, in terms of clinical or biological remission, at 5 years
Primary	Overall survival
Primary	Acute and late toxicity
Primary	Quality of life
Primary	Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)