Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)

NCT00967863 | Active Not Recruiting DMC

• 4 other identifiers: CDR0000649028 UC-0160/0706FRE-FNCLCC-GETUG-18/07062008-A00529-46EU-20966
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 25

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Biochemical or clinical progression-free survival at 5 years

  5 years

Secondary Outcomes (3)

• Overall and specific survival

  10 years

• Acute and late toxicity

  10 years

• Quality of life as measured by QLQ-C30 and PR 25 questionnaires

  10 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.

Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

Arm II

EXPERIMENTAL

Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.

Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

Interventions

3-dimensional conformal radiation therapy RADIATION

Patients undergo radiotherapy

Arm I; Arm II

intensity-modulated radiation therapy RADIATION

Patients undergo radiotherapy

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Unfavorable disease, defined by at least 1 of the following criteria: * Clinical stage T3 or T4 * Gleason score ≥8 * Serum prostate-specific antigen (PSA) ≥20 ng/mL and ≤100 ng/mL * pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy * No pelvic lymph nodes ≥15 mm by CT scan or MRI * No axillary lymph node involvement (pN1) * No bone metastasis * Must be starting hormonal treatment on or up to 6 months before beginning radiotherapy PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy \>5 years * Must be enrolled in a social security program * No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years * No severe uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg) * No contraindication to luteinizing hormone-releasing hormone agonists * No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease) * No hip prosthesis * Must not be deprived of liberty or under guardianship * No geographical, social, or psychological reasons that would preclude follow up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior pelvic irradiation * At least 3-4 months since prior transurethral resection * No other prior surgery for prostate cancer * No concurrent participation in another clinical trial which would require approval upon entry to this trial

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 (25)

Institut de Cancérologie de l'Ouest Paul Papin

Angers, 49933, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

Centre hospitalier Métropole Savoie

Chambéry, 73011, France

Location

Clinique Léonard de Vinci

Chambray-lès-Tours, 37175, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hopital La Timone

Marseille, 13386, France

Location

Centre de Cancérologie du Grand Montpellier

Montpellier, 34070, France

Location

Centre Val D'Aurelle

Montpellier, 34298, France

Location

Centre Azureen de Cancerologie

Mougins, 06250, France

Location

Chr Orleans

Orléans, 45000, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Centre CARIO - HPCA

Plérin, 22190, France

Location

Hôpital Jean Bernard - CHU de Poitiers

Poitiers, 86021, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Gauducheau

Saint-Herblain, 44800, France

Location

Hia Begin

Saint-Mandé, 94160, France

Location

Institut de Cancérologie LUCIEN NEUWIRTH

Saint-Priest-en-Jarez, 42270, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Clinique PASTEUR

Toulouse, 31076, France

Location

Ch Bretonneau

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• Kim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2.

  PMID: 36884035 DERIVED

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

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)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Christophe HENNEQUIN, PhD

  Hopital Saint-Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: October 1, 2008
• Primary Completion: March 1, 2015
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (25)