We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967863
First Posted: August 28, 2009
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UNICANCER
  Purpose

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.


Condition Intervention
Prostate Cancer Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Biochemical or clinical progression-free survival at 5 years [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Overall and specific survival [ Time Frame: 10 years ]
  • Acute and late toxicity [ Time Frame: 10 years ]
  • Quality of life as measured by QLQ-C30 and PR 25 questionnaires [ Time Frame: 10 years ]

Estimated Enrollment: 500
Study Start Date: October 2008
Estimated Study Completion Date: October 2026
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiotherapy
Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy
Experimental: Arm II
Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiotherapy
Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy

Detailed Description:

OBJECTIVES:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967863


Locations
France
Institut de Cancérologie de l'Ouest Paul Papin
Angers, France, 49933
Institut Bergonie
Bordeaux, France, 33076
Centre Francois Baclesse
Caen, France, 14076
Clinique Léonard de Vinci
Chambray-lès-Tours, France, 37175
Centre hospitalier Métropole Savoie
Chambéry, France, 73011
CHU Henri Mondor
Créteil, France, 94010
Centre Léon Bérard
Lyon, France, 69373
Hopital La Timone
Marseille, France, 13386
Centre de Cancérologie du Grand Montpellier
Montpellier, France, 34070
Centre Val D'Aurelle
Montpellier, France, 34298
Centre Azureen de Cancerologie
Mougins, France, 06250
Chr Orleans
Orléans, France, 45000
Hôpital Saint Louis
Paris, France, 75010
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69310
Centre CARIO - HPCA
Plérin, France, 22190
Hôpital Jean Bernard - CHU de Poitiers
Poitiers, France, 86021
Centre Eugène Marquis
Rennes, France, 35042
Centre Henri Becquerel
Rouen, France, 76038
Centre Rene Gauducheau
Saint-Herblain, France, 44800
Hia Begin
Saint-Mandé, France, 94160
Institut de Cancérologie LUCIEN NEUWIRTH
Saint-Priest-en-Jarez, France, 42270
Centre Paul Strauss
Strasbourg, France, 67065
Clinique PASTEUR
Toulouse, France, 31076
Ch Bretonneau
Tours, France, 37044
Centre Alexis Vautrin
Vandoeuvre Les Nancys, France, 54511
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Christophe HENNEQUIN, PhD Hopital Saint-Louis
  More Information

Additional Information:
Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00967863     History of Changes
Other Study ID Numbers: CDR0000649028 UC-0160/0706
FRE-FNCLCC-GETUG-18/0706
2008-A00529-46
EU-20966
First Submitted: August 27, 2009
First Posted: August 28, 2009
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UNICANCER:
adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases