Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CAP01-11
Study information
Scientific title
Observational Epidemiological Study of disease progression and therapeutic approach in prostate Cancer Patients: an observational study
Acronym
GESCAP
Study hypothesis
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
Clinical Investigation Ethical Committee of the Hospital Virgen de las Nieves de Granada (Spain)
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
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/01/2012
Overall trial end date
01/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
25 centres with 4087 patients
Participant exclusion criteria
Patients who have withdrawn their informed consent to take part in the study
Recruitment start date
01/01/2012
Recruitment end date
01/03/2015
Locations
Countries of recruitment
Spain
Trial participating centre
University Hospital Morales Meseguer
Murcia
30008
Spain
Funders
Funder type
Industry
Funder name
Astellas Pharma S.A. (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. Cozar JM et al. BJU Int. 2012; 110(11 Pt B):E701-706.
2. Cozar JM. et al. Actas Urol Esp. 2013;37(1):12-19.