Informations générales (source: ClinicalTrials.gov)
An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients (CARLHA-2)
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
janvier 2020
décembre 2033
29 juin 2024
This is a multicenter, randomized, open label, phase III study comparing the efficacy and
safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT)
and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in
high-risk postprostatectomy biochemically relapsed prostate cancer patients.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:39 | Contacter | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Pierre BLANCHARD | 20/02/2024 09:54:11 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:27 | Contacter | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice - France | Shakeel SUMODHEE | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | Ahmed BENYOUCEF | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Emile ROUX - Le Puy-en-Velay - France | Kiêù LÊ | Contact (sur clinicalTrials) | |||
| Centre Paul STRAUSS - Strasbourg - France | Inès MENOUX | Contact (sur clinicalTrials) | |||
| Clinique Claude Bernard - Albi - France | Pierre AUBERDIAC | Contact (sur clinicalTrials) | |||
| Clinique Pasteur - ONCORAD - Toulouse - France | Igor LATORZEFF | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de la Loire Lucien Neuwirth - Saint-Priest-en-Jarez - France | Nicolas MAGNE | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Montpellier - Montpellier - France | David AZRIA | Contact (sur clinicalTrials) | |||
| Institut Jean Godinot - Reims - France | Grégoire BOUCHE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut de Cancérologie de l'Ouest - Angers - France | Stéphane SUPIOT | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - Saint Herblain - France | Stéphane SUPIOT | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie Paris Nord - Sarcelles - France | Guillaume SERGENT | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
1. Patients must have signed a written informed consent form prior to any trial
specific procedures
2. Age ≥18 years old and ≤80 years old
3. Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with
radical prostatectomy
4. Tumor stage pT2, pT3 or pT4* (*only in case of bladder neck involvement)
5. Patients should have no clinical and radiological signs (18FCH-PET CT-scan or
68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse or
pelvic nodal relapse (N1) detected on PET CT-scan can be randomized
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
7. PSA ≥0.2 ng/mL at the time of randomization with an elevation of PSA over three
consecutive assays. PSA increases over a 1-month interval minimum
8. At least 3 months between radical prostatectomy and randomization.
9. High-risk features as defined by at least one of these characteristics: PSA at
relapse >0.5 ng/mL or Gleason score >7 or tumor stage pT3b or resection margins R0
or PSA doubling time ≤6 months or pelvic lymph node relapse (N1, ≤5 lymph nodes)
10. Adequate renal function: serum creatinine <1.5 x upper limit of normal (ULN) or a
calculated corrected creatinine clearance ≥60 mL/min according to the
Cockcroft-Gault formula, creatinemia <2 ULN
11. Adequate hepatic function: total bilirubin ≤1.5 x ULN (unless documented Gilbert's
syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5
x ULN
12. Patients with QTc prolongation <500 ms, inclusion should considered after close
benefit/risk assessment and cardiologist advice
13. Patients must be willing and able to comply with the protocol for the duration of
the study including undergoing treatment and scheduled visits and examinations
14. Patients must be affiliated to the Social Security System
1. Patients must have signed a written informed consent form prior to any trial
specific procedures
2. Age ≥18 years old and ≤80 years old
3. Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with
radical prostatectomy
4. Tumor stage pT2, pT3 or pT4* (*only in case of bladder neck involvement)
5. Patients should have no clinical and radiological signs (18FCH-PET CT-scan or
68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse or
pelvic nodal relapse (N1) detected on PET CT-scan can be randomized
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
7. PSA ≥0.2 ng/mL at the time of randomization with an elevation of PSA over three
consecutive assays. PSA increases over a 1-month interval minimum
8. At least 3 months between radical prostatectomy and randomization.
9. High-risk features as defined by at least one of these characteristics: PSA at
relapse >0.5 ng/mL or Gleason score >7 or tumor stage pT3b or resection margins R0
or PSA doubling time ≤6 months or pelvic lymph node relapse (N1, ≤5 lymph nodes)
10. Adequate renal function: serum creatinine <1.5 x upper limit of normal (ULN) or a
calculated corrected creatinine clearance ≥60 mL/min according to the
Cockcroft-Gault formula, creatinemia <2 ULN
11. Adequate hepatic function: total bilirubin ≤1.5 x ULN (unless documented Gilbert's
syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5
x ULN
12. Patients with QTc prolongation <500 ms, inclusion should considered after close
benefit/risk assessment and cardiologist advice
13. Patients must be willing and able to comply with the protocol for the duration of
the study including undergoing treatment and scheduled visits and examinations
14. Patients must be affiliated to the Social Security System
1. Previous treatment with hormone therapy for prostate cancer
2. Histology other than adenocarcinoma
3. Surgical or chemical castration
4. Other malignancy except adequately treated basal cell carcinoma of the skin or other
malignancy from which the patient has been cured for at least 5 years
5. Previous pelvic radiotherapy
6. More than 5 (>5) pelvic lymph node relapses
7. Paraaortic, thoracic or supaclavicular nodal relapse (M1a)
8. History of Inflammatory bowel disease or any malabsorption syndrome or conditions
that would interfere with enteral absorption
9. Uncontrolled hypertension (defined as systolic blood pressure (BP) ≥140 mmHg or
diastolic BP ≥90 mmHg). Patients with a history of hypertension are allowed provided
blood pressure is controlled by anti-hypertensive treatment
10. Clinically significant history of liver disease consistent with Child-Pugh class B
or C
11. History of seizure or condition that may pre-dispose to seizure (including, but not
limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year
prior to randomization; brain arteriovenous malformation or intracranial masses such
as schwannomas and meningiomas that are causing edema or mass effect)
12. Medications known to lower the seizure threshold must be discontinued or substituted
at least 4 weeks prior to study entry
13. Severe or unstable angina, myocardial infarction, symptomatic congestive heart
failure, arterial or venous thromboembolic events (e.g pulmonary embolism,
cerebrovascular accident including transient ischemic attacks) or clinically
significant ventricular arrhythmias within 6 months prior to randomization
14. Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes
ventricular arrhythmias (e.g, heart failure, hypokalemia, or a family history of a
long QT syndrome), a QT or corrected QT (QTc) interval >500 ms at baseline
15. Medications known to prolong QTc
16. Known hypersensitivity to apalutamide or to any of its components
17. Galactosemia, Glucose-galactose malabsorption or lactase deficiency
18. Inability or willingness to swallow oral medication
19. Individual deprived of liberty or placed under the authority of a tutor
20. Patients already included in another therapeutic trial with an experimental drug or
having been given an experimental drug within the 30 days before inclusion