Medical and Economic Evaluation for Intermediate-risk Prostate Cancer

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02271659
• Other study ID #: 2011-704
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2014
• Last updated: September 12, 2016
• Start date: June 2013
• Est. completion date: June 2021

Study information

• Verified date: September 2016
• Source: Hospices Civils de Lyon
• Contact: Olivier CHAPET, MD
• Phone: 0033 4 78 86 42 59
• Email: olivier.chapet[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 298
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Brachytherapy boost with external beam radiotherapy
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.
• Exclusive external beam radiotherapy
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.

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Albi
France	CHU Jean MINJOZ	Besançon
France	Clinique Tivoli	Bordeaux
France	Institut Bergonie	Bordeaux
France	CHRU Morvan	Brest
France	Centre Francois Baclesse	Caen
France	Centre Georges François Leclerc	Dijon
France	Hopital de la Tronche	Grenoble
France	Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard	Lyon
France	Centre d'oncologie et de radiothérapie Mâcon	Macon
France	Institut Paoli Calmette	Marseille
France	Centre Val D'Aurelle	Montpellier
France	Institut de Cancerologie de Lorraine Alexis Vautrin	Nancy
France	Clinique Hartmann	Neuilly Sur Seine
France	Centre Antoine Lacassagne	Nice
France	Hopital George Pompidou	Paris
France	Hopital Saint-Louis	Paris
France	Institut Curie	Paris
France	Hospices Civils de Lyon	Pierre-Bénite
France	CHU Poitiers	Poitiers
France	Institut Jean Godinot,	Reims
France	Polyclinique Courlancy	Reims
France	Centre Eugène Marquis	Rennes
France	Centre Henry Becquerel	Rouen
France	Institut Cancérologique de la Loire	Saint-priest En Jarez
France	Centre Paul Strauss	Strasbourg
France	Institut Claudius Regaud	Toulouse
France	Institut Gustave Roussy	Villejuif
France	Clinique du TONKIN	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The evaluation of the overall survival at 5 years.	All cause mortality	5 years	No
Secondary	The evaluation of the specific survival at 5 years	Mortality due to prostate cancer	5 years	No
Secondary	The evaluation of the survival without any metastatic evolution at 5 years		5 years	No
Secondary	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)	5 years	No
Secondary	Medical and economical evaluation.	The complete medical and economical evaluation of the strategies	5 years	No