PROSTATIC ADENOCARCINOMA CHEMICAL CASTRATION RESISTANT MedDRA version: 9.1 Level: HLT Classification code 10018187
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Triptorelin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA S. LUIGI GONZAGA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) prostatic adenoca with histological confirmation and clinical or radiological evidence of metastatic desease 2) metastatic desease hormone refractory 3) desease progression defined as PSA increase >50% compared with nadir 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)serum PSA increase without radiological evidence of metastatic desease 2) previous chemoteraphy for prostatic ca 3) peripheral neuropathy >G1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: THIS TRIAL IS UNDERTAKEN TO EVALUATE THE IMPACT IN TERMS OF SURVIVAL OF TWO TREATMENTE DECISION: 1) TO WITHDRAW OR CONTINUE ANDROGEN DEPRIVATION THERAPY 2) TO CONTINUE OR SUSPEND DOCETAXEL ADMINISTRATION IN PATIENTS WITH PROSTATE CANCER AND PSA RESPONSE;Secondary Objective: COMPARATIVE EVALUATION OF EFFECTS OF ANDROGEN DEPRIVATION THERAPY WITHDRAWAL VERSUS MAINTENANCE AND INTERMITTENT DOCETAXEL VERSUS CONTINUOUS ADMINISTRATION IN TERMS OF: 1)ANTINEOPLASTIC ACTIVITY 2)PAIN CONTROL 3) TOXICITY 4) QoL 5) Costs;Primary end point(s): Overall survival | — |
Countries
Italy
Outcome results
None listed