Condition category
Cancer
Date applied
02/06/2014
Date assigned
01/08/2014
Last edited
03/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Bernardino Minana

ORCID ID

Contact details

University Hospital Morales Meseguer
Urology Department
Av Marques de los Velez
s/n
Murcia
30008
Spain

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 measures

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. Patient’s 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

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

Sponsor information

Organisation

Astelas Pharma S.A. (Spain)

Sponsor details

Parque Empresarial La Finca
Paseo del Club Deportivo
1
Bloque 14
2 planta
Pozuelo de Alarcon
28223
Spain

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes