A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse
Launched by UNICANCER · Sep 24, 2013
Trial Information
Current as of April 25, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the combination of cabazitaxel, a chemotherapy drug, and pelvic radiotherapy to see how well they work together in treating men with high-risk localized prostate cancer. The goal is to find out if this combination can help patients live longer without their cancer progressing. To qualify for the trial, participants need to be men aged between 18 and 75 who have been diagnosed with prostate cancer and show at least two high-risk features, such as a high Gleason score or elevated prostate-specific antigen levels.
If you or a loved one is considering participating in this trial, you should expect to undergo a treatment plan that includes cabazitaxel and pelvic radiotherapy, as well as regular check-ups and tests to monitor your health. It's important to note that participants must not have other serious medical conditions and should not have received prior treatments for prostate cancer, except for certain allowed procedures. This trial is currently active but not recruiting new participants, so check with your healthcare provider for any updates or similar opportunities.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 1. Any T histologically confirmed adenocarcinoma of the prostate
- • 2. No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (\> 1 cm in small diameter)
- • 3. Gleason score ≥ 6
- 4. Meets at least 2 of the following criteria for high-risk:
- • Gleason score ≥ 8
- • T3 or T4 disease (T3 defined by MRI is acceptable)
- • Prostate-specific antigen equal or greater than 20 ng/mL
- • 5. No prior treatment for prostate cancer except lymph node dissection (patients with pN- and pN+ disease can be accrued) or ADT (started up to 6 weeks before randomization).
- • 6. 18 years ≤ Age ≤ 75 years
- • 7. Eastern Cooperative Oncology Group (ECOG) 0-1 performance status
- • 8. Expected life expectancy of more than 10 years
- • 9. Absolute neutrophil count ≥ 1.5 x 10⁹/L
- • 10. Platelets ≥ 100 x 10⁹/L
- • 11. Hb ≥ 9.0 g/dL
- • 12. Hepatic function: serum bilirubin ≤ 1 upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- • 13. Renal function (creatinine clearance using the Chronic Kidney Disease Epidemiology group (CKD-EPI) formula ≥ 60 mL/min).
- • 14. Potentially reproductive patients must agree to use an effective contraceptive method while on treatment and for 6 months after the final dose of investigational product.
- • 15. Patients must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials.
- • 16. Patients who have received the information sheet and signed the informed consent form.
- • 17. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Exclusion Criteria:
- 1. Patients with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
- • 1. infection,
- • 2. cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, left ventricular ejection fraction (LVEF) \> grade 2,
- • 3. uncontrolled diabetes mellitus,
- • 4. current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment),
- • 5. renal disease,
- • 6. active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded,
- • 7. known severely impaired lung function (spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) 70% or less of normal and O2 saturation of 88% or less at rest on room air).
- • 2. Other prior malignancy within the last 5 years, except basal cell skin cancer
- • 3. Physical or psychological condition that would preclude study compliance
- • 4. Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80
- • 5. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- • 6. Patients who received any other investigational drugs within the 30 days prior to the start of cabazitaxel.
- • 7. Previous pelvic irradiation that make prostatic irradiation impossible
- • 8. Severe GI disorders precluding pelvic irradiation
- • 9. Patients already included in another therapeutic trial involving an experimental drug
- • 10. Individual deprived of liberty or placed under the authority of a tutor.
- • 11. Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix 6). A one week wash-out period is necessary for patients who are already on these treatments
Trial Officials
Emmanuelle BOMPAS, Doctor
Principal Investigator
ICO-René Gauducheau - St Herblain
Jean-Christophe EYMARD, Doctor
Principal Investigator
Institut Jean Godinot - Reims
Guilhem ROUBAUD, Doctor
Principal Investigator
Institut Bergonié Bordeaux
Philippe BEUZEBOC, Doctor
Principal Investigator
Institut Curie Paris
Aline GUILLOT, Doctor
Principal Investigator
Institut de Cancérologie Lucien Neuwirth -ST Priest en Jarez
Claude EL KOURI, Doctor
Principal Investigator
Centre Catherine de Sienne - Nantes
Frank PRIOU, Doctor
Principal Investigator
CHD VENDEE - La Roche sur Yon
Aude FLECHON, Doctor
Principal Investigator
CENTRE LEON BERARD - lyon
Igor LATORZEFF, Doctor
Principal Investigator
Clinique Pasteur Toulouse
Karim FIZAZI, Professor
Principal Investigator
Gustave Roussy, Cancer Campus Grand Paris-Paris
Jean BERDAH, Doctor
Principal Investigator
Clinique Ste Marguerite - Hyères
Stéphane CULINE, Professor
Principal Investigator
Hôpital St Louis - Paris
Sophie ABADIE-LACOURTOISIE, Doctor
Principal Investigator
ICO - Paul Papin - Angers
Philippe FOURNERET, Doctor
Principal Investigator
Centre hospitalier de Chambéry - Chambéry
Alain GRANDGIRARD, Doctor
Principal Investigator
Centre hospitalier de Mulhouse - mulhouse
Dominique BESSON, Doctor
Principal Investigator
Clinique Armoricaine de Radiologie - St Brieuc
Loïc MOUREY, Doctor
Principal Investigator
Institut Claudius REGAUD - Toulouse
Alain RUFFION, Professor
Principal Investigator
Centre hospitalier Lyon Sud - Pierre Bénite
Tristan MAURINA, Doctor
Principal Investigator
CHRU Jean Minoz - Besançon
Pierre CLAVERE, Professor
Principal Investigator
CHU Limoges - Limoges
Véronique BECKENDORF, Doctor
Principal Investigator
Institut de Cancérologie de Lorraine
Joan Carles, Doctor
Principal Investigator
Hospital Vall d'Hebron - Barcelone
Riccardo Valdagni, Professor
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei tumori - Milan
Philippe RONCHIN, Docteur
Principal Investigator
Centre Azuréen de Cancérologie - Mougins
Eric LECHEVALLIER, Professor
Principal Investigator
Hôpital de la conception - Marseille
Gwenaëlle GRAVIS, Doctor
Principal Investigator
Institut Paoli Calmettes - Marseille
Elise CHAMPEAUX-ORANGE, Doctor
Principal Investigator
CHR Orléans La Source - Orléans
Xavier ARTIGNAN, Doctor
Principal Investigator
Saint-Gregoire Private Hospital Center
Anne DONEUX, Doctor
Principal Investigator
Clinique Générale d'Annecy
Thibaud HAASER, Doctor
Principal Investigator
Hôpital Haut L'Evèque - Pessac
Youssef TAZI, Doctor
Principal Investigator
STRASBOURG ONCOLOGIE LIBERALE - CLINIQUE SAINTE ANNE - Strasbourg
Stéphane OUDARD, Professor
Principal Investigator
HOPITAL EUROPEEN GEORGES POMPIDOU - Paris
Brigitte LAGUERRE, Doctor
Principal Investigator
CENTRE EUGENE MARQUIS - Rennes
Hakim MAHAMMEDI, Doctor
Principal Investigator
CENTRE JEAN PERRIN - Clermont Ferrand
Nadine HOUEDE, Doctor
Principal Investigator
CHRU de Nîmes Caremeau - Nîmes
Gaël DEPLANQUE, Doctor
Principal Investigator
CH Paris Saint Joseph - Paris
Marjorie BACIUCHKA-PALMARO, Doctor
Principal Investigator
Hôpital Nord Marseille
yazid BELKACEMI, Doctor
Principal Investigator
Hôpital Henri Mondor - Créteil
Mostefa BENNAMOUN, Doctor
Principal Investigator
L'Institut Mutualiste Montsouris-Paris
ali HASBINI, Doctor
Principal Investigator
Clinique Pasteur - Brest
Emmanuel GROSS, Doctor
Principal Investigator
Hôpital privé Clairval - Marseille
Bérengère NARCISO RAHARIMANANA, Doctor
Principal Investigator
CHU de TOURS Hôpital Bretonneau
Carole HELISSEY, Doctor
Principal Investigator
Hôpital d'instruction des armées Bégin - St mandé
Marta GUIX, Doctor
Principal Investigator
Hospital del Mar
Begoña PEREZ-VALDERRAMA, Doctor
Principal Investigator
Hospital Universitario Virgen del Rocio -Sevilla
Enrique GALLARDO, Doctor
Principal Investigator
Parc Tauli Sabadell Hospital Universitari - Sabadell
Maria SAEZ, Doctor
Principal Investigator
H. Virgen de la Victoria - Malaga
Montserrat DOMENECH, Doctor
Principal Investigator
Althaia, Xarxa Universitaria i assistencial de Manresa
Sergio VAZQUEZ ESTEVEZ, Doctor
Principal Investigator
H. Lucus Augusti - Lugo
Luis Miguel Anton APARICIO, Doctor
Principal Investigator
H. Teresa Herrera - Coruna
Maria José MENDEZ VIDAL, Doctor
Principal Investigator
H. Reina Sofia
Pilar LOPEZ CRIADO, Doctor
Principal Investigator
M.D. Anderson Cancer Center
Begoña MELLADO GONZALEZ, Doctor
Principal Investigator
Hospital Clinic of Barcelona
Francisco GOMEZ VEIGA, Doctor
Principal Investigator
University of Salamanca
Salvador VILLA i FREIXA, Doctor
Principal Investigator
ICO Badalona - H.U. Germans Trias
Daniel CASTELLANO, Doctor
Principal Investigator
Hospital Universitario 12 de Octubre
About Unicancer
Unicancer is a leading French cooperative group dedicated to advancing cancer research and treatment through innovative clinical trials. Comprising a network of comprehensive cancer centers, Unicancer focuses on improving patient outcomes by fostering collaboration among healthcare professionals, researchers, and industry partners. The organization is committed to the development and implementation of cutting-edge therapeutic strategies, emphasizing personalized medicine and precision oncology. Through its rigorous research initiatives, Unicancer aims to enhance the understanding of cancer biology and contribute to the development of more effective treatments for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Villejuif, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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