Prostate CancerGETUGP05NCT02271659
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer
A study testing Brachytherapy boost with external beam radiotherapy and Exclusive external beam radiotherapy in people with Prostate Cancer, run by Hospices Civils de Lyon at 29 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Brachytherapy boost with external beam radiotherapy and Exclusive external beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 29 sitesFrance
- Study dates
- Jun 2013to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
France29 sites, 29 recruiting
- Recruiting
Clinique Claude Bernard
Albi, 81000
Laurent VOTRON, MD, 5 63 77 77 50 ext. 0033, votron@claude-bernard-albi.com
- Not yet recruiting
CHU Jean MINJOZ
Besançon, 25030
Yasser HAMMOUD, MD, 3 84 46 14 09 ext. 0033, yhammoud@chu-besancon.fr
- Recruiting
Clinique Tivoli
Bordeaux, 33000
Nathalie BONICHON-LAMICHHANE, MD, 5 56 39 47 28 ext. 0033, Bonichon-lamichhane@wanadoo.fr
- Recruiting
Institut Bergonie
Bordeaux, 33076
Laurence THOMAS, MD, 5 56 33 33 20 ext. 0033, Thomas@bergonie.org
- Recruiting
CHRU Morvan
Brest, 29609
Jean-Pierre MALHAIRE, MD, 2 98 22 37 40 ext. 0033, jean-pierre.malhaire@chu-brest.fr
- Not yet recruiting
Centre Francois Baclesse
Caen, 14076
Marlon SILVA, MD, 2 31 45 50 17 ext. 0033, m.silva@baclesse.unicancer.fr
- Recruiting
Centre Georges François Leclerc
Dijon, 21079
Gilles CREHANGE, MD, 3 80 73 75 18 ext. 0033, gcrehange@dijon.fnclcc.fr
- Recruiting
Hopital de la Tronche
Grenoble, 38043
Michel BOLLA, MD, 4 76 76 55 06 ext. 0033, mbolla@chu-grenoble.fr
- Recruiting
Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard
Lyon, 69373
Pascal POMMIER, MD, 4 78 78 26 52 ext. 0033, pommier@lyon.fnclcc.fr
- Not yet recruiting
Centre d'oncologie et de radiothérapie Mâcon
Mâcon, 71031
Fabrice LORCHEL, MD, 3 85 23 21 00 ext. 0033, lorchel.fabrice@wanadoo.fr
- Recruiting
Institut Paoli Calmette
Marseille, 13273
Naji SALEM, MD, SALEMN@marseille.fnclcc.fr
- Recruiting
Centre Val D'Aurelle
Montpellier, 34298
Carmen LLACER MOSCARDO, MD, 4 67 61 31 34 ext. 0033, carmen.llacer@valdorel.fnclcc.fr
- Recruiting
Institut de Cancerologie de Lorraine Alexis Vautrin
Nancy, 54519
Didier PEIFFERT, MD, d.peiffert@nancy.fnclcc.fr
- Not yet recruiting
Clinique Hartmann
Neuilly-sur-Seine, 92200
Laurent CHAUVEINC, MD, Laurent.chauveinc@free.fr
- Not yet recruiting
Centre Antoine Lacassagne
Nice, 06189
Jean-Michel HANNOUN LEVI, MD, 4 92 03 12 60 ext. 0033, Jean-Michel.HANNOUN-LEVI@nice.fnclcc.fr
- Recruiting
Institut Curie
Paris, 75248
Alain LABIB, MD, alain.labib@curie.net
- Recruiting
Hopital Saint-Louis
Paris, 75475
Christophe HENNEQUIN, MD, 1 42 49 90 24 ext. 0033, christophe.hennequin@sls.ap-hop-paris.fr
- Not yet recruiting
Hopital George Pompidou
Paris, 75908
Martin HOUSSET, MD, 1 56 09 34 21 ext. 0033, martin.housset@egp.aphp.fr
- Recruiting
Hospices Civils de Lyon
Pierre-Bénite, 69495
Olivier CHAPET, MD, 0033 4 78 86 42 59, olivier.chapet@chu-lyon.fr
- Recruiting
CHU Poitiers
Poitiers, 86021
Stéphane GUERIF, MD, 5 49 44 44 85 ext. 0033, s.guerif@chu-poitiers.fr
- Not yet recruiting
Institut Jean Godinot,
Reims, 51056
Tan Dat NGUYEN, MD, 3 26 50 43 51 ext. 0033, tandat.nguyen@reims.fnclcc.fr
- Recruiting
Polyclinique Courlancy
Reims, 51057
Frédéric MALLET, MD, 3 26 84 02 84 ext. 0033, fmallet@iccreims.fr
- Recruiting
Centre Eugène Marquis
Rennes, 50420
Renaud DE CREVOISIER, MD, 2 99 25 30 31 ext. 0033, Renaud.de.crevoisier@igr.fr
- Not yet recruiting
Centre Henry Becquerel
Rouen, 76038
Ahmed BENYOUCEF, MD, 2 32 08 22 62 ext. 0033, ahmed.Benyoucef@rouen.fnclcc.fr
- Recruiting
Institut Cancérologique de la Loire
Saint-Priest-en-Jarez, 42270
Guy DE LAROCHE, MD, 4 77 91 71 02 ext. 0033, guy.delaroche@icloire.fr
- Recruiting
Centre Paul Strauss
Strasbourg, 67065
Marius POP, MD, 3 88 25 85 16 ext. 0033, mpop@strasbourg.fnclcc.fr
- Recruiting
Institut Claudius Regaud
Toulouse, 31052
BACHAUD Jean-Marc, MD, bachaud.jean-marc@claudiusregaud.fr
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Alberto BOSSI, MD, Alberto.BOSSI@igr.fr
- Not yet recruiting
Clinique du TONKIN
Villeurbanne, 69626
ARDIET Jean-Michel, MD, 4 26 68 67 67 ext. 0033, jean-michel.ardiet@wanadoo.fr
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- Brachytherapy boost with external beam radiotherapy, Exclusive external beam radiotherapy
- Keywords
- Prostate, external beam radiotherapy, brachytherapy boost, economical evaluation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachytherapy boost with external beam radiotherapyRadiation
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 radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Brachytherapy boost | Experimental | 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 Receives: Radiation: Brachytherapy boost with external beam radiotherapy |
| Exclusive external beam irradiation | Active comparator | 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. Receives: Radiation: Exclusive external beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (5)
The evaluation of the overall survival at 5 years.
All cause mortality
Measured: 5 years
The evaluation of the specific survival at 5 years
Mortality due to prostate cancer
Measured: 5 years
The evaluation of the survival without any metastatic evolution at 5 years
Measured: 5 years
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)
Measured: 5 years
Medical and economical evaluation.
The complete medical and economical evaluation of the strategies
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier CHAPET, MD, Principal investigator, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271659
- Sponsor's protocol ID
- 2011-704
- Acronym
- GETUGP05
- Status last verified
- Sep 2016
- First submitted
- 2 Jun 2014
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02271659
- Acronym / sponsor ID
- GETUGP05 / 2011-704
- Conditions
- Prostate Cancer
- Keywords
- Prostate, external beam radiotherapy, brachytherapy boost, economical evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brachytherapy boost | Experimental | Radiation: Brachytherapy boost with external beam radiotherapyBrachytherapy 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 irradiation | Active comparator | Radiation: Exclusive external beam radiotherapyExclusive 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachytherapy boost with external beam radiotherapyBras 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. | Radiation | Brachytherapy boost |
| Exclusive external beam radiotherapyBras 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. | Radiation | Exclusive external beam irradiation |
Primary outcome
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 secondary outcomes
The evaluation of the overall survival at 5 years.
Time frame: 5 years
The evaluation of the specific survival at 5 years
Time frame: 5 years
The evaluation of the survival without any metastatic evolution at 5 years
Time frame: 5 years
The study of all toxicities
Time frame: 5 years
Medical and economical evaluation.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier CHAPET, MD principal investigator
HCL
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy boost with external beam radiotherapy and Exclusive external beam radiotherapy in people with Prostate Cancer, run by Hospices Civils de Lyon at 29 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier CHAPET, MD (0033 4 78 86 42 59, olivier.chapet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.