Cabazitaxel in relapsed high-risk HOrmone-SEnsitiveprostate cancer patients. A multicentric Randomized phase II study.C.HO.SE. Trial
- Conditions
- Relapsed high-risk hormone-sensitiveprostate cancerTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2012-004412-55-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 140
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):
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· 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 <1.5 x ULN (If creatinine 1.0 - 1.5 x ULN, creatinine
clearance calculated according to CKD-EPI formula should be =60
mL/min)
· Serum bilirubin < 1 x UNL ASAT and ALAT < 2.5 UNL
9. Ability to fill the quality of life questionnaire
10. Obtained signed informed consent prior to start protocol specific
requirements
11. Patient compliance and geographic proximity that allow adequate
follow-up.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method