Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Recruitment status was: Recruiting
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.
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
- Impact of complete androgen blockade for 4 months [ Designated as safety issue: No ]
- Survival, in terms of clinical or biological remission, at 5 years [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Acute and late toxicity [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
- Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone) [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104741
|Clinique De Rochebelle|
|Ales, France, F-30100|
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Hopital Louis Pasteur|
|Colmar, France, 68024|
|Hopitaux Civils de Colmar|
|Colmar, France, 68024|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94000|
|Hopital Intercommunal De Creteil|
|Creteil, France, 94010|
|Hopital Jean Monnet|
|Epinal, France, 88021|
|Centre Hospitalier Intercommunal des Alpes du Sud|
|Gap, France, 05007|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Hospital Regional Universitaire de Limoges|
|Limoges, France, 87042|
|Centre Leon Berard|
|Lyon, France, 69373|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|CHU de la Timone|
|Marseille, France, 13385|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Hospitalier de Mulhouse|
|Mulhouse, France, 68051|
|Mulhouse, France, 68070|
|Centre Regional Rene Gauducheau|
|Nantes, France, 44035|
|Centre Antoine Lacassagne|
|Nice, France, 06088|
|Clinique De Valdegour|
|Nimes, France, 30900|
|Hopital d'Instruction des Armees du Val de Grace|
|Paris, France, 75005|
|Paris, France, 75475|
|Paris, France, 75651|
|Paris, France, 75970|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Poitiers, France, 86021|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Centre Henri Becquerel|
|Rouen, France, 76000|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Study Chair:||Bernard M. Dubray, MD, PhD||Centre Henri Becquerel|