Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Brachytherapy 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 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.

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.

Brachytherapy boost with 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.

Exclusive external beam radiotherapy

Olivier CHAPET, MD

Julien BERTHILLER

Laurent VOTRON, MD

Yasser HAMMOUD, MD

Nathalie BONICHON-LAMICHHANE, MD

Laurence THOMAS, MD

Jean-Pierre MALHAIRE, MD

Marlon SILVA, MD

Gilles CREHANGE, MD

Michel BOLLA, MD

Pascal POMMIER, MD

Fabrice LORCHEL, MD

Naji SALEM, MD

Carmen LLACER MOSCARDO, MD

Didier PEIFFERT, MD

Laurent CHAUVEINC, MD

Jean-Michel HANNOUN LEVI, MD

Alain LABIB, MD

Christophe HENNEQUIN, MD

Martin HOUSSET, MD

Stéphane GUERIF, MD

Tan Dat NGUYEN, MD

Frédéric MALLET, MD

Renaud DE CREVOISIER, MD

Ahmed BENYOUCEF, MD

Guy DE LAROCHE, MD

Marius POP, MD

BACHAUD Jean-Marc, MD

Alberto BOSSI, MD

ARDIET Jean-Michel, MD

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.

Medical and Economic Evaluation for Intermediate-risk Prostate Cancer

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

Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms

The toxicities include: acute and late toxicities, sexual toxicities, the quality of life of the patients (CTCAE version 4.0)

The complete medical and economical evaluation of the strategies

Hospices Civils de Lyon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer	NCT02271659	Prostate Cancer	Brachytherapy b... Exclusive exter...	18 Years - 80 Years	Hospices Civils de Lyon
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer	NCT02271659	Prostate Cancer	Brachytherapy b... Exclusive exter...	18 Years - 80 Years	Hospices Civils de Lyon

Spots Global Cancer Trial Database for brachytherapy boost with external beam radiotherapy