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

NCT00104741 | Completed Phase 3 DMC

• 3 other identifiers: UC-0160/0207FRE-FNCLCC-GETUG-14/0207EU-20503
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 31

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.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (6)

• Impact of complete androgen blockade for 4 months

• Survival, in terms of clinical or biological remission, at 5 years

• Overall survival

• Acute and late toxicity

• Quality of life

• Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)

Study Arms (2)

radiotherapy alone

ACTIVE COMPARATOR

Radiation: radiation therapy

Radiotherapy + androgene deprivation

EXPERIMENTAL

Drug: flutamide; Drug: triptorelin; Radiation: radiation therapy

Interventions

flutamide DRUG

Radiotherapy + androgene deprivation

triptorelin DRUG

Radiotherapy + androgene deprivation

radiation therapy RADIATION

Radiotherapy + androgene deprivation; radiotherapy alone

Eligibility Criteria

• Age: 0 Years - 74 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (31)

Clinique De Rochebelle

Alès, F-30100, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Hopitaux Civils de Colmar

Colmar, 68024, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94000, France

Location

Hopital Intercommunal De Creteil

Créteil, 94010, France

Location

Hopital Jean Monnet

Épinal, 88021, France

Location

Centre Hospitalier Intercommunal des Alpes du Sud

Gap, 05007, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Centre Hospitalier

Mulhouse, 68070, France

Location

Centre Regional Rene Gauducheau

Nantes, 44035, France

Location

Centre Antoine Lacassagne

Nice, 06088, France

Location

Clinique De Valdegour

Nîmes, 30900, France

Location

Hopital d'Instruction des Armees du Val de Grace

Paris, 75005, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Centre Henri Becquerel

Rouen, 76000, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• 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.

  PMID: 25592642 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Flutamide; Triptorelin Pamoate; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Study Officials

• Bernard M. Dubray, MD, PhD

  Centre Henri Becquerel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: September 10, 2003
• Primary Completion: October 1, 2015
• Study Completion: October 15, 2015
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

FR (31)