Relapsed high-risk hormone-sensitive prostate cancer
Conditions
Interventions
Trade Name: JEVTANA
Product Name: CABAZITAXEL
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
AZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be considered for enrollment into the study: 1. Pathologically confirmed adenocarcinoma of the prostate 2. Absence of distant metastasis at the diagnosis 3. Adequate radical treatment for prostate cancer: the following treatments are allowed for management of initial disease · Radical prostatectomy · External radical radiotherapy · Interstitial brachytherapy 4. Biochemical failure after primary treatment with curative intent (as per EAU 2011 guideline definitions): XML File Identifier: pgnqMWgEieDXnccenPA31nFWt5A= Page 15/25 · After RP: PSA level > 0.2 ng/ml with a second confirmation · After EBRT: PSA level > 2 ng/ml above the nadir · After IB: : PSA level > 2 ng/ml above the nadir 5. ADT for biochemical failure (all LHRH-A formulations and dosages are allowed) according to the daily clinical practice 6. Failure to achieve PSA nadir value after 6 months with ADT: patients who receiving ADT are followed every two months and are evaluated after 6 months of treatment comparing the PSA value to the value which was achieved at the nadir after radical treatment and before biochemical progression. The patients could be classified according to three different conditions: · Good responders to ADT (6-month PSA is equal or less than PSA nadir value) · Partially responders to ADT (6-month PSA is lower than value before ADT start but is greater than PSA nadir value) · Non responders to ADT (6-month PSA is greater than PSA nadir value or is increasing after a transient response) For the purposes of the present study are eligible only the patients partially responders 7. ECOG Performance Status 0 or 1 8. Laboratory requirements at entry EudraCT No. C.HO.SE. Protocol, Version 1.1, July 2012 28 · Absolute neutrophils = 1.5 x 109/L · Platelets = 100 x 109/L, Hemoglobin = 9 g/dl · Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will not be included in the study: 1. Age > 75 years 2. Prior systemic chemotherapy 3. Prior complete androgen blockage 4. Prior ADT for the biochemical failure lasting more than 6 months 5. History of prior malignancies, except for cured non melanoma skin cancer or other cancer curatively treated and with no evidence of disease for at least five years 6. Significant neurological or psychiatric disorders such as dementia that would prohibit them to understanding or rendering informed consent or from fully complying with treatment and follow-up 7. Other serious concomitant illness of medical conditions 8. Any other condition which in the judgment of the investigator would place the subject at undue risk or interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) plus ADT versus ADT plus prednisone (Arm B) in term of progression-free survival (PFS) in hormone-sensitive prostate cancer patients who fail to achieve PSA nadir value after 6 months of LHRH-A therapy for rising PSA after curative therapy.;Secondary Objective: To compare the two study arms for: · biochemical PFS · time to castration-resistance development · metastasis-free survival · overall survival · tolerability · impact on the quality of life;Primary end point(s): Kaplan-Meier estimates of progression-free survival;Timepoint(s) of evaluation of this end point: ARM A. The on-study evaluations must be performed on day 1 of each cabazitaxel course (or at least within 2 days before). The final evaluation must be performed within 4 weeks after the last drug administration. ARM B.The "on-study" evaluations will be performed within 1 week after randomization and at the 10th week after randomization.The final evaluation must be performed between the 19th and the 22nd week after randomization.Patients who are progression-free at the end of the "on study" period must be evaluated every 2 months until progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Kaplan-Meier estimates of biochemical progression-free survival · Kaplan-Meier estimates of time to distant metastasis appearance · Kaplan-Meier estimates of time to castration resistance development · Kaplan-Meier estimates of overall survival · type and grade of any adverse reaction to treatment with cabazitaxel, according to CTC-AE v. 4.03 · functional scales and items of EORTC QLQ-C30 v.3.0 questionnaire;Timepoint(s) of evaluation of this end point: ARM A. The on-study evaluations must be performed on day 1 of each cabazitaxel course (or at least within 2 days before). The final evaluation must be performed within 4 weeks after the last drug administration. ARM B.The "on-study" evaluations will be performed within 1 week after randomization and at the 10th week after randomization.The final evaluation must be performed between the 19th and the 22nd week after randomization.Patients who are progression-free at the end of the "on study" period must be evaluated every 2 months until progression. | — |
Countries
Italy
Contacts
Public ContactMEDICAL ONCOLOGY, S.CHIARA HOSPITAL
AZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO
Outcome results
None listed