Original Title: La efectividad y seguridad de los distintos tratamientos del cáncer de próstata

Authors' objectives: This review aims to determine the effectiveness and safety of the different therapeutic options available for prostate cancer.

Authors' results and conclusions: In the treatment of clinically localised cancer, randomised clinical tests do not provide any evidence to indicate that any of the three available options, i.e., expectant management, surgery or radiotherapy, are better than the others. Expectant care is a possible option, especially in older patients, persons of more than 74 years of age, or even younger persons, if they have lowvolume, well-differentiated tumours (Gleason grade 2 to 4), PSA levels of less than 10 ng/ml, and especially when they suffer from other serious pathologies that might reduce their life expectancy. It is recommended to offer active treatment to patients with prostate cancer in localised clinical state and with life expectancies of at least 10 years. There is not sufficient evidence to suggest conclusively that any of the curative options, i.e., surgery or radiotherapy, is better than the other with regard to an improvement in overall survival or in the specific survival in cases of prostate cancer. According to data provided by observational surveys, on the one hand, surgery seems to provide somewhat better results with regard to survival rates but, on the other hand, complications such as urinary incontinence or impotence often appear with greater frequency. With regard to cases in which a decision is made to treat this illness by means of radiotherapy, there is evidence of good quality from randomised clinical tests that find that external conformed radiotherapy produces fewer secondary effects than conventional radiotherapy. There is also evidence from randomised clinical tests that show that greater dosages of radiotherapy are associated with improvements in the control of tumours and in some cases, such as that of Gleason tumours of 8 to 10 with PSA levels of over 10ng/ml, with an improvement in the survival rate. In view of the fact that observational surveys have found that the frequency of secondary effects increases with the dosage, it seems reasonable to limit the use of higher dosages to patients with high Gleason grades and PSA levels. With regard to the role of brachytherapy, it should be pointed out that there is no good quality evidence to endorse brachytherapy as a more efficient treatment than those currently used in our environment for patients with localised prostate cancer. Regarding the possible role of administering hormonal treatment prior to prostatectomy, based on the results of clinical tests published, it may be concluded that there are no significant advantages to justify this. Data from randomised clinical tests show that androgenic suppression prior to or during external radiotherapy is a form of treatment that may have a positive impact on certain groups of patients, but that that it is still not clear which of these will benefit or whether its use offsets the secondary effects of the treatment. For this reason, we believe that the use of these anti-androgenic therapies in patients who are to be subjected to radiotherapy should be restricted to those patients who take part in clinical tests intended to clarify these doubts. In the treatment of locally advanced prostate cancer we believe that there is no good evidence to suggest that any of the therapeutic options is better than the others or the expectant care option. The decision must be taken taking the patient’s life expectancy into account, whether there is serious co-morbidity or not, and his/her preferences. The use of continuous hormonal therapy does not seem, in principle, to be justified more than in patients with very reduced life expectancy and the role of intermittent hormonal therapy is being assessed in the clinical tests currently in progress. With regard to the approach to disseminated prostate cancer, based on evidence from the meta-analysis of randomised clinical tests, it can be stated that both the orchidectomy and analogous LHRH treatments produce similar results with regard to the survival of patients and the progression-free time of the disease. There do not appear to be significant differences either in the results of different LHRH analogues, although none of the clinical tests that have been made has made direct comparisons between these. For its part, compared to the orchidectomy, treatments with non steroid anti-androgens are associated with a lower overall survival rate. There is not sufficient evidence to draw a conclusion as to which is the most appropriate moment to start the treatment, whether this is at the moment the dissemination of the disease is detected, when relevant symptomatology is produced or while this is progressing. The evidence from the meta-analysis of randomised clinical tests finds no significant differences to favour the use of the maximum androgenic blockage compared to surgical or hormonal castration alone. Although maximum androgenic blockage is associated with an increase in survival, this increase is very small and it is not clear whether this offsets the negative impact on the quality of life in view of the greater adverse effects of maximum blockage. In patients with hormonal-independent metastasis of prostate cancer, there will be no evidence to clarify in a reliable manner which are the safest and most effective treatment options, until the results of the numerous clinical tests in progress are completed and published.

Authors' methods: In this study, a bibliographical search (completed on November 20 2001) was made of randomised clinical tests that provide data regarding the effectiveness of the different options for treating prostate cancer in the following computerised database: Medline, CancerLit, Cochrane Library, the database of the NHS Centre for Reviews and Dissemination of the University of York, and Spanish Medical Index.

Project Status: Completed

Year Published: 2002

URL for published report: https://www.euskadi.eus/contenidos/informacion/2002_osteba_publicacion/es_def/adjuntos/2002/d_02-06_cancer_prostata.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Basque Office for Health Technology Assessment, Health Department Basque Government (OSTEBA)</p>