Evaluation of clinical benefits of abiraterone acetate in "real life" study
| ISRCTN | ISRCTN52513758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52513758 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 30/04/2016
- Registration date
- 23/05/2016
- Last edited
- 18/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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?
At least nine 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
Contact information
Scientific
Urology Department ASL Abruzzo 2
via S.Camillo de Lellis 1
Vasto
66054
Italy
 ORCID ID |
0000-0002-0712-2719 |
|---|
Study information
| Study design | Retrospective multicentre observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Abiraterone acetate plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: multicentre Italian “real life” study |
| Study objectives | 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(s) | Ethics approval was waived by the departmental IRB. |
| Health condition(s) or problem(s) studied | Metastatic castration resistant prostate cancer |
| Intervention | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Abiraterone acetate |
| Primary outcome measure | 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 study start date | 01/08/2015 |
| Completion date | 30/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 150 |
| Total final enrolment | 145 |
| Key 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 |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/11/2015 |
| Date of final enrolment | 01/02/2016 |
Locations
Countries of recruitment
- Italy
Study participating centre
Chieti
66100
Italy
Sponsor information
Hospital/treatment centre
via S.Camillo de Lellis 1
Vasto
66054
Italy
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| 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. An oral communication on these data was done during the National Congress of Italian Society of Urology , held in Venice in October 2016. |
| IPD sharing plan | The dataset supporting the conclusions of this article is included as additional file to the results publication. The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/11/2017 | Yes | No |
Editorial Notes
18/02/2022: The following changes have been made:
1. The individual participant data (IPD) sharing statement has been added.
2. The total final enrolment number has been added from the reference.
01/12/2017: Ethics information has been updated.
13/11/2017: Publication reference added.
02/02/2017: The overall trial dates have been updated from 01/11/2015 - 01/11/2016 to 01/08/2015 - 30/11/2017 and the recruitment start date has been updated from 01/11/2013 to 01/11/2015.
30/01/2017: The following changes have been made to the record:
1. The number of centres the study is run from has been changed from 8 to 9.
2. The target number of participants has been updated from 100 to 150.
2. The publication and dissemination plan has been added.
