Evaluation of clinical benefits of abiraterone acetate in "real life" study

Abiraterone acetate plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: multicentre Italian “real life” study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN52513758

Enrollment

150

Registered

2016-05-23

Start date

2015-11-01

Completion date

Unknown

Last updated

2022-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic castration resistant prostate cancer Cancer Malignant neoplasm of prostate

Interventions

All patients enrolled were patients with an indication to receive abiraterone acetate (AA). All consecutive patients with biochemically or histologically confirmed progressive metastatic castration-re

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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) 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 3. Dropout rate and the reasons for discontinuation, evaluated monthly or earlier in case of premature dropout 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	—

Measure

Time frame

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) 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 3. Dropout rate and the reasons for discontinuation, evaluated monthly or earlier in case of premature dropout 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

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026