Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Prostate cancer is a very common cancer affecting men. The prostate is a small gland in the pelvis. It is found only in men and is usually the size of a satsuma. Its function is to help with the production of semen, producing a thick white fluid to be mixed with sperm. Cancer of the prostate usually develops slowly, so patients may not be aware that they have the disease for many years. In some cases, the cancer is only diagnosed at a later stage, when the disease has already spread (and called metastatic prostate cancer). Symptoms include needing to urinate more frequently than before, needing to rush to the toilet, having problems passing urine, and feeling that the bladder is not completely empty after urinating. In advanced cases, the cancer may spread to the bones and lymph nodes and, more rarely, the lungs and the liver. Treatment options include radiotherapy, hormone therapy, chemotherapy and partial or complete removal of the prostate. Testosterone usually makes the cancer grow more quickly so treatments can be given to stop the body producing so much of this hormone. In some cases, the part of the testicle that produces the testosterone is removed. After a time, these treatments can stop working, at which point the cancer is known as castration resistant prostate cancer. Studies have shown that a treatment called abiraterone acetate (AA) can improve survival for men with metastatic castration-resistant prostate cancer. This study aims to gain a better understanding regarding the use of this drug in clinical practice.

Who can participate?
Men diagnosed with metastatic prostate cancer, treated with AA.

What does the study involve?
Patients are treated with 1000mg of AA once a day and 5mg prednisone twice a day. This treatment continues until the disease progresses, the participant dies or the treatment becomes too toxic to take any more.

What are the possible benefits and risks of participating?
Participants may benefit from taking part in this study though receiving a comprehensive, tailored follow-up.

Where is the study run from?
Eight prostate cancer treatment centers in Italy.

When is study starting and how long is it expected to run for?
November 2015 to November 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Luca Cindolo

Trial website

Contact information



Primary contact

Dr Luca Cindolo


Contact details

Urology Department ASL Abruzzo 2
via S.Camillo de Lellis 1

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

The aim of the study is to verify in clinical practice the results of RCTs concerning the abiraterone acetate in chemonaive patients wih metastatic castration-resistant prostate cancer.

Ethics approval

Not provided at time of registration

Study design

Retrospective multicentre observational

Primary study design


Secondary study design

Cross sectional study

Trial setting


Trial type


Patient information sheet


Metastatic castration resistant prostate cancer


All patients enrolled were patients with an indication to receive abiraterone acetate (AA). All consecutive patients with biochemically or histologically confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) and castrate levels of testosterone (<50 ng/dl.), chemonaive, treated with AA plus prednisone in 8 Italian tertiary cancer centres were gathered into a dedicated database. Patients were treated with AA 1000mg once daily in association with with prednisone 5mg twice a day until disease progression, death or unacceptable toxicity.

Intervention type



Phase IV

Drug names

Abiraterone acetate

Primary outcome measures

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

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

More than 100

Participant exclusion criteria

Participants not fulfilling the inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Urology Department
ASL Abruzzo 2

Sponsor information


Urology Department ASL Abruzzo 2

Sponsor details

via S.Camillo de Lellis 1

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

A brief report on progression free survival and on patient's satisfaction will be done in the summer of 2016; a complete paper with OS data and longer follow-up will be prepared in Winter 2016/2017

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/05/2016: Internal review