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Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms

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Trial Information

Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.


Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2
years

Inclusion Criteria


Inclusion criteria :

- Documentation of histological prostate cancer;

- Patients with metastatic CRPC (Castration-Resistant Metastatic Prostate Cancer) who
progressed with hormone deprivation, including the withdrawal of antiandrogen-class
drugs for at least 4 weeks, and 6 weeks for bicalutamide or if documented that PSA
did not decrease during 3 months of this therapy;

- Documentation of metastasis by imaging (computerized tomography [CT], magnetic
resonance imaging [MRI] or bone scan), in patients with PSA < 20 ng/mL at the time of
inclusion

- Provide minor PSA response (characterized by a reduction between 1% and 49%) or
increase up to 24% in PSA levels, in relation to the value measured before starting
docetaxel therapy, measured at least 7 days after the fourth cycle of docetaxel;

- Patient has received 4 cycles of docetaxel at a dose of 75 mg/m2 ;

- ECOG performance status of 0 or 1;

- Marrow, liver and renal function within acceptable values;

- PSA ≥ 2 ng/mL;

- Testosterone level ≤ 50 ng/dL (for patients with no prior history of orchiectomy).

Exclusion criteria:

- Prior use of chemotherapy, except for docetaxel for four cycles;

- Documented disease progression during treatment with docetaxel (first 4 cycles);

- Patients with metastases resulting in neurological damage;

- Inability to continue receiving gonadotropin-releasing hormone agonists in patients
with no prior history of orchiectomy;

- Use of recombinant methionyl human granulocyte-colony stimulating factor
non-glycosylated (G-CSF) in the 24 hours preceding baseline;

- Any other current neoplasia or over the past 5 years, except for basal cell skin
carcinoma or squamous skin cell carcinoma;

- Known seropositivity for HIV (Human immunodeficiency Virus );

- Concomitant diseases, such as significant neurological or psychiatric disease;
uncontrolled hypercalcemia or any other serious comorbidity;

- Hypersensitivity or allergy to any of the study treatments.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median time to PSA progression

Outcome Time Frame:

up to 60 days

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Brazil: National Health Surveillance Agency

Study ID:

CABAZ_L_05933

NCT ID:

NCT01576029

Start Date:

October 2012

Completion Date:

November 2014

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

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