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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: radiation therapy; Drug: flutamide; Drug: triptorelin

• Registration Number: NCT00104741
• Lead Sponsor: UNICANCER

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.

Study Timeline

• Study Start: 2003-09-10
• Study First Submitted: 2005-03-03
• Study First Submitted QC: 2005-03-03
• Study First Posted: 2005-03-04
• Primary Completion: 2015-10
• Study Completion: 2015-10-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 378

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiotherapy alone	radiation therapy	-
Radiotherapy + androgene deprivation	radiation therapy	-
Radiotherapy + androgene deprivation	flutamide	-
Radiotherapy + androgene deprivation	triptorelin	-

Primary Outcome Measures

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

Trial Locations

Locations (31)

Centre Hospital Regional Universitaire de Limoges; 🇫🇷 Limoges, France

Centre Hospitalier Universitaire Henri Mondor; 🇫🇷 Creteil, France

Clinique De Rochebelle; 🇫🇷 Ales, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

CHU de la Timone; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire Bretonneau de Tours; 🇫🇷 Tours, France

Hopital Louis Pasteur; 🇫🇷 Colmar, France

Hopitaux Civils de Colmar; 🇫🇷 Colmar, France

Centre Hospitalier Intercommunal des Alpes du Sud; 🇫🇷 Gap, France

Hopital Intercommunal De Creteil; 🇫🇷 Creteil, France

Hopital Jean Monnet; 🇫🇷 Epinal, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Hospitalier de Mulhouse; 🇫🇷 Mulhouse, France

Centre Hospitalier; 🇫🇷 Mulhouse, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Regional Rene Gauducheau; 🇫🇷 Nantes, France

Hopital d'Instruction des Armees du Val de Grace; 🇫🇷 Paris, France

Clinique De Valdegour; 🇫🇷 Nimes, France

Hopital Saint-Louis; 🇫🇷 Paris, France

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

CHU Poitiers; 🇫🇷 Poitiers, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France