Prostate cancer is one of the major health problems of the male population. Its frequency increases with age: 90% of cases are diagnosed in people older than 65. The aetiology is not entirely clear, although it is known to be related to factors such as environmental, lifestyle, family history and genetic^1,2.

It is estimated that in 2000 there were 1,555,000 cases in the world of men with prostate cancer³. For men, it is the third most common cancer in the world and in Spain^1,3, and represents approximately 11% of all neoplasias in European men⁴.

The estimated prevalence in Spain in 2001 was 157.9 cases/100,000 inhabitants. Of these, 21% had been diagnosed within the previous year; 46%, within the previous 4 years; 23%, between 5 and 10 years beforehand; and 10% had been ill for over 10 years⁵.

The prevalence of prostate cancer is increasing, and it is expected that this trend will continue due to several factors, such as the detection of more cases at earlier stages of the disease, increased survival thanks to diagnostic and therapeutic improvements and the longer life expectancy of the population⁵. We also know that many prostate tumours remain dormant, as only one-third of those discovered in autopsies were clinically discovered².

It is difficult to study the incidence of prostate cancer, given the limited number of cancer population records¹. ABased on available data, it is estimated that in the year 2000, 543,000 new cases of prostate cancer appeared in the world³. The incidence in Spain in 1998 was 10,659 new cases, with a rate^b of 45.33 per 100,000 inhabitants. This is one of the lowest rates in the European Union, which that year had 68 cases per 100,000 inhabitants^1,2. During the period 1997-2000, the incidence in Spain was 13,212 new cases a year, with an annual rate of 56.29 per 100,000 inhabitants-year¹.

The incidence of prostate cancer increased in all Spanish records (1983-97), which may be explained partly by better quality information, but mainly by three factors: increased life expectancy (which increases the age population), the use of prostate-specific antigen (PSA) measurements since the late eighties, which allows the detection of the disease at earlier stages, and the existence of more and better image diagnostic methods¹.

It is estimated that in 2000 there were 204,000 deaths in the world from prostate cancer³. In European Union males, prostate cancer accounts for 3% of all deaths and 9-10% of deaths from neoplasia^1,4. It is the third leading cause of cancer death in Spain and Europe^1,2,4,6. The mortality rate in Spain rose progressively up to 1998, until reaching a rate^c of 24 deaths per 100,000, corresponding to 5,728 deaths^1,2,7. Subsequently, this rate began to decline, probably due to improvements in diagnosis and certification of the cause of death², reaching a rate of 18.22 per 100,000 inhabitants in 2005, with approximately 5,500 mortalities⁷.

The survival rate in Spain in 2003 was around 86% for the year of diagnosis and 65.5% after 5 years, figures comparable to those of neighbouring countries^1,2.

With regard to decision-making in the clinical management of prostate cancer, we know that there is variability. For example, in the choice of radical or expectant treatment at the time of initial diagnosis, the amount of radiotherapy applied, clinical management after treatment with intent to cure and in rates of prostatectomy^8-13.

Within Spain, geographical differences for the risk of death from prostate cancer are not very pronounced, and no geographical pattern is clear^1,2,7

The Clinical Practice Guidelines (CPG) are a set of “recommendations developed in a systematic manner to help professionals and patients to make decisions on the most appropriate health care, and to select the most appropriate diagnostic or therapeutic options when dealing with a health problem or a specific clinical condition”¹⁴.

Since 2006, the Ministry of Health and Consumer Affairs in Spain has promoted the development of a Programme for preparing clinical practice guidelines based on scientific evidence in the Quality Plan for the National Health Service (SNS). A collaboration agreement between the Ministry, through its SNS Quality Agency, and the Carlos III Health Institute was established in the framework of this programme, with different health technology evaluation agencies and bodies. A common methodology for preparing a CPG was defined in this agreement, which was embodied in a methodology manual¹⁴, and which also prompted several evidence-based guides to be produced.

Several international CPGs on prostate cancer have been developed, for example by the European Association of Urology⁴, the National Comprehensive Cancer Network (NCCN) in the United States¹⁵ or the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom^16,17. By contrast, there are hardly any clinical practice guidelines on prostate cancer in our resources. The Prostate OncoGuide by the Catalan Health Agency for Technological Evaluation in Medical Research¹⁸, 2004, is based on the revision and compilation of other clinical practice guidelines on the same subject.

As a result, and taking into account the high prevalence of this neoplasia and the existing variations in clinical management, within the framework of the collaboration agreement with the health technology evaluation agencies and units, the Ministry commissioned the Aragon Institute of Health Sciences, I+CS, to prepare the current guide based on the evidence of prostate cancer treatment, with the aim of boosting the cancer health strategy adopted by the Interterritorial Council¹⁹.

This document is the complete version of the Clinical Practice Guidelines for Prostate Cancer Treatment (http://www.guiasalud.es).