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

Sponsored by:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00104741

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: flutamide Drug: triptorelin Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

Drug Information available for: Flutamide Triptorelin Triptorelin pamoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Estimated Enrollment:	450
Study Start Date:	July 2004

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

Ages Eligible for Study:	up to 74 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104741

Locations

France
Centre Alexis Vautrin	Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Contact Person 33-3-8359-8400
Centre Antoine Lacassagne	Recruiting
Nice, France, 06088
Contact: J. M. Hannoun-Levi, MD 33-4-9203-1260
Centre Eugene Marquis	Recruiting
Rennes, France, 35064
Contact: Elizabeth Le Prise, MD 33-2-9925-3000 elptrennes@fnclcc.fr
Centre Henri Becquerel	Recruiting
Rouen, France, 76000
Contact: Bernard M. Dubray, MD, PhD 33-232-082-262
Centre Hospital Regional Universitaire de Limoges	Recruiting
Limoges, France, 87042
Contact: Pierre Clavere, MD 33-5-5505-6268 pierre.clavere@chu-limoges.fr
Centre Hospitalier de Gap	Recruiting
Gap, France, 05007
Contact: Abdellatif Zribi, MD 33-4-9240-6785
Centre Hospitalier de Mulhouse	Recruiting
Mulhouse, France, 68051
Contact: Contact Person 33-3-8964-7522
Centre Hospitalier Lyon Sud	Recruiting
Pierre Benite, France, 69495
Contact: Contact Person 33-4-78-86-11-58
Centre Hospitalier Universitaire Bretonneau de Tours	Recruiting
Tours, France, 37044
Contact: Olivier Le Floch, MD 33-2-4747-4776 lefloch@med.univ-tours.fr
Centre Hospitalier Universitaire Henri Mondor	Recruiting
Creteil, France, 94000
Contact: Jean-Leon Lagrange, MD 33-1-49-814-524 jean-leon.lagrange@hmn.aphp.fr
Centre Hospitalier	Recruiting
Mulhouse, France, 68070
Contact: Alain Grandgirard 33-3-8964-7522
Centre Leon Berard	Recruiting
Lyon, France, 69373
Contact: Pascal Pommier, MD 33-4-7878-2648 pommier@lyon.fnclcc.fr
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Contact: Eric Lartigau, MD, PhD 33-3-2029-5911 e-lartigau@o-lambret.fr
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Recruiting
Montpellier, France, 34298
Contact: Jean-Bernard Dubois, MD 33-4-6761-3100
Centre Regional Rene Gauducheau	Recruiting
Nantes, France, 44035
Contact: Sylvain Bourdin, MD 33-2-4067-9900
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Recruiting
Marseille, France, 13273
Contact: Contact Person 33-91-22-37-00
CHU Pitie-Salpetriere	Recruiting
Paris, France, 75651
Contact: Jean-Marc Simon 33-142-178-174
CHU Poitiers	Recruiting
Poitiers, France, 86021
Contact: Contact Person 33-549-444-538
Clinique De Rochebelle	Recruiting
Ales, France, F-30100
Contact: Jacques Cretin 33-4-6654-2110
Clinique De Valdegour	Recruiting
Nimes, France, 30900
Contact: Jacques Cretin, MD 33-46-662-58-02
Hopital d'Instruction des Armees du Val de Grace	Recruiting
Paris, France, 75005
Contact: Maryse Fayolle-Campana 33-1-4051-4558
Hopital Intercommunal De Creteil	Recruiting
Creteil, France, 94010
Contact: Michel Martin, MD 33-1-45-17-52-10 michel.martin@chicreteil.fr
Hopital Jean Monnet	Recruiting
Epinal, France, BP590
Contact: Michel Aubertel 33-3-2968-7020
Hopital Louis Pasteur	Recruiting
Colmar, France, 68024
Contact: Contact Person 33-03-89-12-4102
Hopital Saint-Louis	Recruiting
Paris, France, 75475
Contact: Christophe Hennequin, PhD 33-1-4249-4949 christophe.hennequin@sls.ap-hop-paris.fr
Hopital Tenon	Recruiting
Paris, France, 75970
Contact: Francoise Pene, MD 33-1-5601-6562 francoisepene@tnn.aphp.paris.fr
Hopitaux Civils de Colmar	Recruiting
Colmar, France, 68024
Contact: Contact Person 33-3-8912-4000
Institut Claudius Regaud	Recruiting
Toulouse, France, 31052
Contact: Jean-Marc Bachaud, MD 33-5-6142-4242
Institut Jean Godinot	Recruiting
Reims, France, 51056
Contact: Tan Dat Nguyen, MD 33-03-2650-4351 tandat.nguyen@reims.fnclcc.fr
Institut Sainte Catherine	Recruiting
Avignon, France, 84082
Contact: Bruno Chauvet, MD 33-4-9027-6182
CHU de la Timone	Recruiting
Marseille, France, 13385
Contact: Contact person 33-91-385-708

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Bernard M. Dubray, MD, PhD

Centre Henri Becquerel

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000416088, FRE-FNCLCC-GETUG-14/0207, EU-20503
Study First Received:	March 3, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00104741 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II prostate cancer
stage III prostate cancer

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Contraceptive Agents
Hormone Antagonists
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms

Genital Diseases, Male
Flutamide
Hormones
Androgen Antagonists
Triptorelin
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Reproductive Control Agents

Luteolytic Agents
Genital Diseases, Male
Flutamide
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Neoplasms by Site
Triptorelin
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009