Clinical trial NCT02271659: Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
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
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate
external beam radiotherapy
brachytherapy boost
economical evaluation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 298
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: 5 years
Secondary outcomes:
measure: The evaluation of the overall survival at 5 years.
timeFrame: 5 years
measure: The evaluation of the specific survival at 5 years
timeFrame: 5 years
measure: The evaluation of the survival without any metastatic evolution at 5 years
timeFrame: 5 years
measure: The study of all toxicities
timeFrame: 5 years
measure: Medical and economical evaluation.
timeFrame: 5 years
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Besançon
country: France
facility: CHU Jean MINJOZ
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Institut Bergonie
city: Brest
country: France
facility: CHRU Morvan
city: Caen
country: France
facility: Centre Francois Baclesse
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Grenoble
country: France
facility: Hopital de la Tronche
city: Lyon
country: France
facility: Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard
city: Macon
country: France
facility: Centre d'oncologie et de radiothérapie Mâcon
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: Centre Val D'Aurelle
city: Nancy
country: France
facility: Institut de Cancerologie de Lorraine Alexis Vautrin
city: Neuilly Sur Seine
country: France
facility: Clinique Hartmann
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital George Pompidou
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: Institut Jean Godinot,
city: Reims
country: France
facility: Polyclinique Courlancy
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henry Becquerel
city: Saint-priest En Jarez
country: France
facility: Institut Cancérologique de la Loire
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villeurbanne
country: France
facility: Clinique du TONKIN
Study officials:
affiliation: HCL
name: Olivier CHAPET, MD
role: PRINCIPAL_INVESTIGATOR
References: