Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
GETUGP05
1 other identifier
interventional
298
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Jun 2013
Longer than P75 for not_applicable prostate-cancer
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedSeptember 13, 2016
September 1, 2016
8 years
June 2, 2014
September 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
5 years
Secondary Outcomes (5)
The evaluation of the overall survival at 5 years.
5 years
The evaluation of the specific survival at 5 years
5 years
The evaluation of the survival without any metastatic evolution at 5 years
5 years
The study of all toxicities
5 years
Medical and economical evaluation.
5 years
Study Arms (2)
Brachytherapy boost
EXPERIMENTALBrachytherapy 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 irradiation
ACTIVE COMPARATORExclusive 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- PSA level \> 20;
- Gleason \> 7;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Clinique Claude Bernard
Albi, 81000, France
CHU Jean MINJOZ
Besançon, 25030, France
Clinique Tivoli
Bordeaux, 33000, France
Institut Bergonie
Bordeaux, 33076, France
CHRU Morvan
Brest, 29609, France
Centre Francois Baclesse
Caen, 14076, France
Centre Georges François Leclerc
Dijon, 21079, France
Hopital de la Tronche
Grenoble, 38043, France
Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmette
Marseille, 13273, France
Centre d'oncologie et de radiothérapie Mâcon
Mâcon, 71031, France
Centre Val D'Aurelle
Montpellier, 34298, France
Institut de Cancerologie de Lorraine Alexis Vautrin
Nancy, 54519, France
Clinique Hartmann
Neuilly-sur-Seine, 92200, France
Centre Antoine Lacassagne
Nice, 06189, France
Institut Curie
Paris, 75248, France
Hopital Saint-Louis
Paris, 75475, France
Hopital George Pompidou
Paris, 75908, France
Hospices Civils de Lyon
Pierre-Bénite, 69495, France
CHU Poitiers
Poitiers, 86021, France
Institut Jean Godinot,
Reims, 51056, France
Polyclinique Courlancy
Reims, 51057, France
Centre Eugène Marquis
Rennes, 50420, France
Centre Henry Becquerel
Rouen, 76038, France
Institut Cancérologique de la Loire
Saint-Priest-en-Jarez, 42270, France
Centre Paul Strauss
Strasbourg, 67065, France
Institut Claudius Regaud
Toulouse, 31052, France
Institut Gustave Roussy
Villejuif, 94805, France
Clinique du TONKIN
Villeurbanne, 69626, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier CHAPET, MD
HCL
Central Study Contacts
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
June 2, 2014
First Posted
October 22, 2014
Study Start
June 1, 2013
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
September 13, 2016
Record last verified: 2016-09