Taxane-naive patients with metastatic hormone-refractory prostate cancer. MedDRA version: 9.1 Level: HLT Classification code 10036908 Term: Prostatic neoplasms malignant
Conditions
Interventions
Trade Name: QUADRAMET
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Samarium (153Sm) lexidronam
Concentration unit: MBq/kg megabecquerel(s)/kilogram
Concentration type: equal
Concent
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of prostate cancer. 2. Hormone-refractory disease as defined in by two consecutive rises (one week apart) in PSA with testosterone within castration levels (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Predominance of visceral metastases 2. Patients with risk of pathologic bone fracture who need immediate intervention. 3. Previous chemotherapy within the last 5 years. 4. Previous external beam therapy on more than 30% of bone marrow. 5. Any of the following abnormal baseline hematological values: Hemoglobin 1.5 ULN (upper limit of normal) SGPT/ALT and SGOT/AST > 1.5 x ULN 5. Abnormal renal function test Serum creatinine > 1.5 x ULN 6. Very extensive bone metastatic involvement, such as ?super scan? on scintigraphy. 7. Flutamide, Finasteride, Bicalutamide, megestrol acetate, cyproterone acetate or nitulamide within 6 weeks of randomization. 8. Cardiovascular: clinically relevant abnormalities, myocardial infarctions or other severe coronary artery disease within the prior six months, cardiac arrhythmia requiring medication or uncontrolled arterial hypertension. 9. Cardiac failure or non-compensated active heart disease (> class II of NYHA classification). 10. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma in situ. 11. Any other investigational drug within 4 weeks of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare time-to-progression (TTP) of 153Sm-EDTMP and Docetaxel + Prednisone (Arm 1) to Docetaxel + Prednisone (Arm 2).;Secondary Objective: The secondary objectives are comparison between the treatment arms of:  Tumor response  Overall survival  Quality of life  Pain assessment  Safety;Primary end point(s): Time-to-progression is the time from the first study drug administration until documented disease progression. | — |
Countries
France, Italy
Outcome results
None listed