ANDROGEN DEPRIVATION THERAPY WITHDRAWAL VERSUS MAINTENANCE AND INTERMITTENT DOCETAXEL THERAPY VERSUS CONTINUOUS ADMINISTRATION IN PATIENTS WITH PROSTATE CANCER RESISTANT TO CHEMICAL CASTRATION - PON-PC-02
- Conditions
- PROSTATIC ADENOCARCINOMA CHEMICAL CASTRATION RESISTANTMedDRA version: 9.1Level: HLTClassification code 10018187
- Registration Number
- EUCTR2010-019004-24-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA S. LUIGI GONZAGA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
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
1)serum PSA increase without radiological evidence of metastatic desease 2) previous chemoteraphy for prostatic ca 3) peripheral neuropathy >G1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method