Observational Epidemiological Study of disease progression and therapeutic approach in prostate Cancer Patients
| ISRCTN | ISRCTN19893319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19893319 |
| Secondary identifying numbers | CAP01-11 |
- Submission date
- 02/06/2014
- Registration date
- 01/08/2014
- Last edited
- 25/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The prostate is a small, satsuma sized gland, found between the penis and the bladder. It helps to make semen. Prostate cancer (PCa) is one of the most common cancers in the world. A Spanish epidemiological study in 2010 (a study that looks at patterns, causes and effects of a disease in a population) found that, in Spain, there were 81.82 cases of PCa per 100,000 men and there were 72.40 cases per 100,000 men in Europe as a whole. There are a number of different treatment
options for PCa. These include vigilant monitoring, radical prostatectomy, external radiotherapy, brachytherapy, external radiotherapy combined with hormone therapy, hormone monotherapy, biphosphonates and chemotherapy. Here, we have designed a new epidemiological study to find out the 1, 2 and 3-year survival rate for different PCa treatments for those patients that took part in the 2010 Spanish epidemiological study.
Who can participate?
Patients who had been included in the 2010 Spanish epidemiological study with newly diagnosed PCa.
What does the study involve?
Data for each of the participants in the study is collected for years 2011 to 2013 from their medical records. This is then looked at to find out information on different treatments and their survival rates.
What are the possible benefits and risks of participating?
There are no benefits or risks to participants as this is an observational trial.
Where is the study run from?
The study is run from a total of 25 hospitals that took part in the Spanish epidemiological study in 2010.
When is the study starting and how long is it expected to run for?
January 2012 to March 2015
Who is funding the study?
Astellas Pharma S.A. (Spain)
Who is the main contact?
Dr Bernardino Minana
Contact information
Scientific
University Hospital Morales Meseguer
Urology Department
Av Marques de los Velez, s/n
Murcia
30008
Spain
Study information
| Study design | Epidemiological observational multicentre national study. Patient data will be collected retrospectively from the medical records. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Observational Epidemiological Study of disease progression and therapeutic approach in prostate Cancer Patients: an observational study |
| Study acronym | GESCAP |
| Study objectives | In order to know the 1, 2 and 3 year survival rate, both biochemical progression-free survival and clinical progression-free survival, and to study the therapeutic approach in PCa patients we designed this Observational Epidemiological Study. |
| Ethics approval(s) | Clinical Investigation Ethical Committee of the Hospital Virgen de las Nieves de Granada (Spain) |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | This is an epidemiological, observational, multicentre, national study. A cohort of patients diagnosed with PCa in 2010 included in the Epidemiological study of the estimation of the incidence of PCa in Spain - 2010" will be studied. Patient data will be collected retrospectively from the medical records. Thus, data relative to 2011 will be collected during the early months of 2012, while, following the same procedure, data included in the medical records during 2012 and 2013 will be recorded in the study CRF in the early months of 2013 and 2014, respectively. The clinical variables required to determine the biochemical progression-free survival and clinical progression-free survival will be collected in the 3 study reference years: 2011, 2012 and 2013. It is an observational study. |
| Intervention type | Other |
| Primary outcome measure | 1. Biochemical progression-free survival at 1, 2 and 3 years after being diagnosed in 2010 2. Clinical progression-free survival at 1, 2 and 3 years after being diagnosed in 2010 |
| Secondary outcome measures | 1. Patients clinical variables at the time of diagnosis associated with the 1 and 3 year survival 2. Therapeutic approach 3. Cancer-specific survival and overall survival |
| Overall study start date | 01/01/2012 |
| Completion date | 01/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 25 centres with 4087 patients |
| Key inclusion criteria | Patient that was included in the study with code CaP01-10 with newly diagnosed, histopathologically confirmed PCa in any stage, between 1 January and 31 December 2010 |
| Key exclusion criteria | Patients who have withdrawn their informed consent to take part in the study |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 01/03/2015 |
Locations
Countries of recruitment
- Spain
Study participating centre
30008
Spain
Sponsor information
Industry
Parque Empresarial La Finca
Paseo del Club Deportivo, 1, Bloque 14, 2 planta
Pozuelo de Alarcon
28223
Spain
"ROR" |
https://ror.org/01cjash87 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2016 | 25/06/2020 | Yes | No |
| Results article | results | 01/07/2017 | 25/06/2020 | Yes | No |
| Results article | results | 01/01/2019 | 25/06/2020 | Yes | No |
Editorial Notes
25/06/2020: Publication references added.
