Medical and Economic Evaluation for Intermediate-risk Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer

• Registration Number: NCT02271659
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 298

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	5 years	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

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

Trial Locations

Locations (29)

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

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