Evaluation of clinical benefits of abiraterone acetate in real life study
Phase 4
Completed
- Conditions
- Metastatic castration resistant prostate cancerCancerMalignant neoplasm of prostate
- Registration Number
- ISRCTN52513758
- Lead Sponsor
- rology Department ASL Abruzzo 2
- Brief Summary
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29126389 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 145
Inclusion Criteria
1. Men over the age of 18
2. Biochemically or histologically confirmed progressive mCRPC
3. Castrate levels of testosterone (<50 ng/dl)
4. Chemonaive
5. Eligible for abiraterone acetate
Exclusion Criteria
Does not meet the inclusion criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival of patients enrolled (Overall Survival (OS), defined as time from the first dose of AA to the first clinical (pain, general status) or radiographic event), assessed from the time between treatment initiation to either the date of death or of last follow-up for surviving patients.
- Secondary Outcome Measures
Name Time Method <br> 1. PSA changes measured at the baseline and at 12 weeks (the PSA decline was defined as a response at 12 wk equal or greater than 50% in PSA relative to baseline)<br> 2. Toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 4.02 toxicity scale, assessed be evaluated monthly or earlier in case of toxic event<br> 3. Dropout rate and the reasons for discontinuation, evaluated monthly or earlier in case of premature dropout<br> 4. Patient’s satisfaction about the treatment, using a 4-items specific questionnaire (My condition has been: 1- greatly improved, 2- improved, 3- not changed, 4- worsened, during treatment”), evaluated every 12weeks or earlier in case of dropout<br>