Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)
NCT ID: NCT00967863
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
500 participants
INTERVENTIONAL
2008-10-31
2026-10-31
Brief Summary
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PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.
Detailed Description
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Primary
* Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer receiving prolonged hormone therapy.
Secondary
* Evaluate overall and specific survival.
* Assess acute and late toxicities of different modalities (conformal or intensity-modulated radiotherapy).
* Evaluate toxicities of the different doses with respect to hormonal therapy.
* Assess the quality of life (QLQ-C30 and PR 25).
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
* Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3 years.
After completion of study treatment, patients are followed up periodically for 10 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
3-dimensional conformal radiation therapy
Patients undergo radiotherapy
intensity-modulated radiation therapy
Patients undergo radiotherapy
Arm II
Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
3-dimensional conformal radiation therapy
Patients undergo radiotherapy
intensity-modulated radiation therapy
Patients undergo radiotherapy
Interventions
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3-dimensional conformal radiation therapy
Patients undergo radiotherapy
intensity-modulated radiation therapy
Patients undergo radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
MALE
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Christophe HENNEQUIN, PhD
Role: PRINCIPAL_INVESTIGATOR
Hopital Saint-Louis
Locations
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Institut de Cancérologie de l'Ouest Paul Papin
Angers, , France
Institut Bergonie
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Centre hospitalier Métropole Savoie
Chambéry, , France
Clinique Léonard de Vinci
Chambray-lès-Tours, , France
CHU Henri Mondor
Créteil, , France
Centre Léon Bérard
Lyon, , France
Hopital La Timone
Marseille, , France
Centre de Cancérologie du Grand Montpellier
Montpellier, , France
Centre Val D'Aurelle
Montpellier, , France
Centre Azureen de Cancerologie
Mougins, , France
Chr Orleans
Orléans, , France
Hôpital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre CARIO - HPCA
Plérin, , France
Hôpital Jean Bernard - CHU de Poitiers
Poitiers, , France
Centre Eugène Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Gauducheau
Saint-Herblain, , France
Hia Begin
Saint-Mandé, , France
Institut de Cancérologie LUCIEN NEUWIRTH
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , France
Clinique PASTEUR
Toulouse, , France
Ch Bretonneau
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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References
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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.
Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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FRE-FNCLCC-GETUG-18/0706
Identifier Type: -
Identifier Source: secondary_id
2008-A00529-46
Identifier Type: OTHER
Identifier Source: secondary_id
EU-20966
Identifier Type: -
Identifier Source: secondary_id
CDR0000649028 UC-0160/0706
Identifier Type: -
Identifier Source: org_study_id