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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancérologie de l'Ouest Paul Papin
  • Institut Bergonie
  • Centre Francois Baclesse
  • Clinique Léonard de Vinci
  • Centre hospitalier Métropole Savoie
  • CHU Henri Mondor
  • Centre Léon Bérard
  • Hopital La Timone
  • Centre de Cancérologie du Grand Montpellier
  • Centre Val D'Aurelle
  • Centre Azureen de Cancerologie
  • Chr Orleans
  • Hôpital Saint Louis
  • Centre Hospitalier Lyon Sud
  • Centre CARIO - HPCA
  • Hôpital Jean Bernard - CHU de Poitiers
  • Centre Eugène Marquis
  • Centre Henri Becquerel
  • Centre Rene Gauducheau
  • Hia Begin
  • Institut de Cancérologie LUCIEN NEUWIRTH
  • Centre Paul Strauss
  • Clinique PASTEUR
  • Ch Bretonneau
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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

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

Outcomes

Primary Outcome Measures

Biochemical or clinical progression-free survival at 5 years

Secondary Outcome Measures

Overall and specific survival
Acute and late toxicity
Quality of life as measured by QLQ-C30 and PR 25 questionnaires

Full Information

First Posted
August 27, 2009
Last Updated
October 24, 2022
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00967863
Brief Title
Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2008 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Intervention Description
Patients undergo radiotherapy
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Intervention Description
Patients undergo radiotherapy
Primary Outcome Measure Information:
Title
Biochemical or clinical progression-free survival at 5 years
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall and specific survival
Time Frame
10 years
Title
Acute and late toxicity
Time Frame
10 years
Title
Quality of life as measured by QLQ-C30 and PR 25 questionnaires
Time Frame
10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe HENNEQUIN, PhD
Organizational Affiliation
Hopital Saint-Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Clinique Léonard de Vinci
City
Chambray-lès-Tours
ZIP/Postal Code
37175
Country
France
Facility Name
Centre hospitalier Métropole Savoie
City
Chambéry
ZIP/Postal Code
73011
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital La Timone
City
Marseille
ZIP/Postal Code
13386
Country
France
Facility Name
Centre de Cancérologie du Grand Montpellier
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Centre Val D'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Azureen de Cancerologie
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
Chr Orleans
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre CARIO - HPCA
City
Plérin
ZIP/Postal Code
22190
Country
France
Facility Name
Hôpital Jean Bernard - CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Hia Begin
City
Saint-Mandé
ZIP/Postal Code
94160
Country
France
Facility Name
Institut de Cancérologie LUCIEN NEUWIRTH
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Clinique PASTEUR
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Ch Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT00967863
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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