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Medical and Economic Evaluation for Intermediate-risk Prostate Cancer (GETUGP05)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brachytherapy boost with external beam radiotherapy
Exclusive external beam radiotherapy
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, external beam radiotherapy, brachytherapy boost, economical evaluation

Eligibility Criteria

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

Inclusion Criteria:

  • age between 18 and 80 years;
  • life expectancy of greater than 10 years;
  • prostate adenocarcinoma histologically proven;
  • prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-2.
  • the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);
  • the signed consent form.

Exclusion Criteria:

  • PSA level > 20;
  • Gleason > 7;
  • clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion);
  • prostate volume > 60 cc;
  • pelvic lymph nodes involvement at dissection or imaging (ADP > 1.5 cm);
  • concurrent hormone therapy;
  • the presence of distant metastasis (M1);
  • history of abdominal or pelvic irradiation;
  • history of prostate resection in the previous 6 months and/or not allowing the implantation of markers;
  • history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma);
  • urinary discomfort with an IPSS (International Prostate Symptom Score) > 15 (without alpha-blocking);
  • inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
  • other undergoing study that may interfere with the present study;
  • patient under legal protection measure.

Sites / Locations

  • Clinique Claude BernardRecruiting
  • CHU Jean MINJOZ
  • Clinique TivoliRecruiting
  • Institut BergonieRecruiting
  • CHRU MorvanRecruiting
  • Centre Francois Baclesse
  • Centre Georges François LeclercRecruiting
  • Hopital de la TroncheRecruiting
  • Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon BerardRecruiting
  • Centre d'oncologie et de radiothérapie Mâcon
  • Institut Paoli CalmetteRecruiting
  • Centre Val D'AurelleRecruiting
  • Institut de Cancerologie de Lorraine Alexis VautrinRecruiting
  • Clinique Hartmann
  • Centre Antoine Lacassagne
  • Institut CurieRecruiting
  • Hopital Saint-LouisRecruiting
  • Hopital George Pompidou
  • Hospices Civils de LyonRecruiting
  • CHU PoitiersRecruiting
  • Institut Jean Godinot,
  • Polyclinique CourlancyRecruiting
  • Centre Eugène MarquisRecruiting
  • Centre Henry Becquerel
  • Institut Cancérologique de la LoireRecruiting
  • Centre Paul StraussRecruiting
  • Institut Claudius RegaudRecruiting
  • Institut Gustave RoussyRecruiting
  • Clinique du TONKIN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brachytherapy boost

Exclusive external beam irradiation

Arm Description

Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique

Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.

Outcomes

Primary Outcome Measures

Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy
Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms

Secondary Outcome Measures

The evaluation of the overall survival at 5 years.
All cause mortality
The evaluation of the specific survival at 5 years
Mortality due to prostate cancer
The evaluation of the survival without any metastatic evolution at 5 years
The study of all toxicities
The toxicities include: acute and late toxicities, sexual toxicities, the quality of life of the patients (CTCAE version 4.0)
Medical and economical evaluation.
The complete medical and economical evaluation of the strategies

Full Information

First Posted
June 2, 2014
Last Updated
September 12, 2016
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02271659
Brief Title
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
Acronym
GETUGP05
Official Title
Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment. The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, external beam radiotherapy, brachytherapy boost, economical evaluation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Brachytherapy boost
Arm Type
Experimental
Arm Description
Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique
Arm Title
Exclusive external beam irradiation
Arm Type
Active Comparator
Arm Description
Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy boost with external beam radiotherapy
Intervention Description
Bras A: External beam radiotherapy of 46 Gy delivered with a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds from Bard (110Gy) or high dose rate (14Gy) with a iridium-192 source) only to the prostate. Each center will choose the appropriate brachytherapy technique. The number of seeds or needles will depend on the prostate's volume.
Intervention Type
Radiation
Intervention Name(s)
Exclusive external beam radiotherapy
Intervention Description
Bras B: External beam radiotherapy of 46 Gy delivered with photons and a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.
Primary Outcome Measure Information:
Title
Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy
Description
Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms
Time Frame
5 years
Secondary Outcome Measure Information:
Title
The evaluation of the overall survival at 5 years.
Description
All cause mortality
Time Frame
5 years
Title
The evaluation of the specific survival at 5 years
Description
Mortality due to prostate cancer
Time Frame
5 years
Title
The evaluation of the survival without any metastatic evolution at 5 years
Time Frame
5 years
Title
The study of all toxicities
Description
The toxicities include: acute and late toxicities, sexual toxicities, the quality of life of the patients (CTCAE version 4.0)
Time Frame
5 years
Title
Medical and economical evaluation.
Description
The complete medical and economical evaluation of the strategies
Time Frame
5 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
Inclusion Criteria: age between 18 and 80 years; life expectancy of greater than 10 years; prostate adenocarcinoma histologically proven; prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-2. the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006); the signed consent form. Exclusion Criteria: PSA level > 20; Gleason > 7; clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion); prostate volume > 60 cc; pelvic lymph nodes involvement at dissection or imaging (ADP > 1.5 cm); concurrent hormone therapy; the presence of distant metastasis (M1); history of abdominal or pelvic irradiation; history of prostate resection in the previous 6 months and/or not allowing the implantation of markers; history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma); urinary discomfort with an IPSS (International Prostate Symptom Score) > 15 (without alpha-blocking); inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease; other undergoing study that may interfere with the present study; patient under legal protection measure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier CHAPET, MD
Phone
0033 4 78 86 42 59
Email
olivier.chapet@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BERTHILLER
Phone
0033 4 27 85 63 01
Email
julien.berthiller@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier CHAPET, MD
Organizational Affiliation
HCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Claude Bernard
City
Albi
ZIP/Postal Code
81000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent VOTRON, MD
Phone
5 63 77 77 50
Ext
0033
Email
votron@claude-bernard-albi.com
Facility Name
CHU Jean MINJOZ
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasser HAMMOUD, MD
Phone
3 84 46 14 09
Ext
0033
Email
yhammoud@chu-besancon.fr
Facility Name
Clinique Tivoli
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie BONICHON-LAMICHHANE, MD
Phone
5 56 39 47 28
Ext
0033
Email
Bonichon-lamichhane@wanadoo.fr
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence THOMAS, MD
Phone
5 56 33 33 20
Ext
0033
Email
Thomas@bergonie.org
Facility Name
CHRU Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre MALHAIRE, MD
Phone
2 98 22 37 40
Ext
0033
Email
jean-pierre.malhaire@chu-brest.fr
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlon SILVA, MD
Phone
2 31 45 50 17
Ext
0033
Email
m.silva@baclesse.unicancer.fr
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles CREHANGE, MD
Phone
3 80 73 75 18
Ext
0033
Email
gcrehange@dijon.fnclcc.fr
Facility Name
Hopital de la Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel BOLLA, MD
Phone
4 76 76 55 06
Ext
0033
Email
mbolla@chu-grenoble.fr
Facility Name
Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal POMMIER, MD
Phone
4 78 78 26 52
Ext
0033
Email
pommier@lyon.fnclcc.fr
Facility Name
Centre d'oncologie et de radiothérapie Mâcon
City
Macon
ZIP/Postal Code
71031
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice LORCHEL, MD
Phone
3 85 23 21 00
Ext
0033
Email
lorchel.fabrice@wanadoo.fr
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naji SALEM, MD
Email
SALEMN@marseille.fnclcc.fr
Facility Name
Centre Val D'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen LLACER MOSCARDO, MD
Phone
4 67 61 31 34
Ext
0033
Email
carmen.llacer@valdorel.fnclcc.fr
Facility Name
Institut de Cancerologie de Lorraine Alexis Vautrin
City
Nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier PEIFFERT, MD
Email
d.peiffert@nancy.fnclcc.fr
Facility Name
Clinique Hartmann
City
Neuilly Sur Seine
ZIP/Postal Code
92200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent CHAUVEINC, MD
Email
Laurent.chauveinc@free.fr
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel HANNOUN LEVI, MD
Phone
4 92 03 12 60
Ext
0033
Email
Jean-Michel.HANNOUN-LEVI@nice.fnclcc.fr
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain LABIB, MD
Email
alain.labib@curie.net
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe HENNEQUIN, MD
Phone
1 42 49 90 24
Ext
0033
Email
christophe.hennequin@sls.ap-hop-paris.fr
Facility Name
Hopital George Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin HOUSSET, MD
Phone
1 56 09 34 21
Ext
0033
Email
martin.housset@egp.aphp.fr
Facility Name
Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier CHAPET, MD
Phone
0033 4 78 86 42 59
Email
olivier.chapet@chu-lyon.fr
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane GUERIF, MD
Phone
5 49 44 44 85
Ext
0033
Email
s.guerif@chu-poitiers.fr
Facility Name
Institut Jean Godinot,
City
Reims
ZIP/Postal Code
51056
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tan Dat NGUYEN, MD
Phone
3 26 50 43 51
Ext
0033
Email
tandat.nguyen@reims.fnclcc.fr
Facility Name
Polyclinique Courlancy
City
Reims
ZIP/Postal Code
51057
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric MALLET, MD
Phone
3 26 84 02 84
Ext
0033
Email
fmallet@iccreims.fr
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
50420
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud DE CREVOISIER, MD
Phone
2 99 25 30 31
Ext
0033
Email
Renaud.de.crevoisier@igr.fr
Facility Name
Centre Henry Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed BENYOUCEF, MD
Phone
2 32 08 22 62
Ext
0033
Email
ahmed.Benyoucef@rouen.fnclcc.fr
Facility Name
Institut Cancérologique de la Loire
City
Saint-priest En Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy DE LAROCHE, MD
Phone
4 77 91 71 02
Ext
0033
Email
guy.delaroche@icloire.fr
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marius POP, MD
Phone
3 88 25 85 16
Ext
0033
Email
mpop@strasbourg.fnclcc.fr
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BACHAUD Jean-Marc, MD
Email
bachaud.jean-marc@claudiusregaud.fr
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto BOSSI, MD
Email
Alberto.BOSSI@igr.fr
Facility Name
Clinique du TONKIN
City
Villeurbanne
ZIP/Postal Code
69626
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ARDIET Jean-Michel, MD
Phone
4 26 68 67 67
Ext
0033
Email
jean-michel.ardiet@wanadoo.fr

12. IPD Sharing Statement

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Medical and Economic Evaluation for Intermediate-risk Prostate Cancer

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