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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02271659
Other study ID # 2011-704
Secondary ID
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


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
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