Medical and Economic Evaluation for Intermediate-risk Prostate Cancer (GETUGP05)

September 12, 2016 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

298

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi, France, 81000
      • Besançon, France, 25030
        • Not yet recruiting
        • Chu Jean Minjoz
        • Contact:
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonie
        • Contact:
      • Bordeaux, France, 33000
      • Brest, France, 29609
      • Caen, France, 14076
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges Francois Leclerc
        • Contact:
      • Grenoble, France, 38043
        • Recruiting
        • Hôpital de la Tronche
        • Contact:
      • Lyon, France, 69373
        • Recruiting
        • Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard
        • Contact:
      • Macon, France, 71031
        • Not yet recruiting
        • Centre d'oncologie et de radiothérapie Mâcon
        • Contact:
      • Marseille, France, 13273
      • Montpellier, France, 34298
      • Nancy, France, 54519
      • Neuilly Sur Seine, France, 92200
      • Nice, France, 06189
      • Paris, France, 75475
      • Paris, France, 75248
      • Paris, France, 75908
        • Not yet recruiting
        • hôpital george Pompidou
        • Contact:
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
      • Poitiers, France, 86021
        • Recruiting
        • CHU Poitiers
        • Contact:
      • Reims, France, 51056
      • Reims, France, 51057
        • Recruiting
        • Polyclinique Courlancy
        • Contact:
      • Rennes, France, 50420
        • Recruiting
        • Centre Eugene Marquis
        • Contact:
      • Rouen, France, 76038
      • Saint-priest En Jarez, France, 42270
        • Recruiting
        • Institut Cancérologique de la Loire
        • Contact:
      • Strasbourg, France, 67065
      • Toulouse, France, 31052
      • Villejuif, France, 94805
      • Villeurbanne, France, 69626

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brachytherapy boost
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
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.
Active Comparator: Exclusive external beam irradiation
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.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Olivier CHAPET, MD, HCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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