Research team: Montserrat Ferrer Fores, Adela Virginia Becerra Bachino, Yolanda Pardo Cladellas, Olatz Garin Boronat, Oriol Cunillera Puértoles, Angels Pont Acuña, Paquita Morrilla Aguilar, Jordi Alonso Caballero and “Grupo multicéntrico español de cáncer de próstata localizado” (Multicentric Spanish Group for localizad prostate cancer).
The controversy on the preferred treatment against localized prostate cancer, which started in the late 90s with the publication of two articles which showed results in the control of cancer progression for braquitherapy and external radiotherapy, similar to those of radical prostatectomy, is still opened. Considering that secondary effects of some of the options can be different, the importance of also directing research on patients Health Related Quality of Life (HRQL) follows.
General Objectives: The aim of the project is to compare the effectivity at short and long term of the three more established treatment modalities for localize prostate cancer patients in terms of survival free of biochemical progression (PSA), secondary effects and Quality of Life.
Methodology: This is a prospective study, taken on at different periods (1, 3, 6, 12, 24, 36, 48 and 60 months) before and after treatment with 766 localized prostate cancer diagnosed patients. Patients were recluted consecutively in April-2003 and March-2005 in out-patient departments at 10 Spanish hospitals (2 in Urology and 8 in Radiotherapy Oncology). The decision on the election of the treatment was made together by both the doctor and the patient, with the following distribution: 206 Surgery, 324 Braquitherapy and 236 External Radiotherapy.
The inicial patient evaluation was done before treatment and it has been followed during three years. Currently we are taking the annual evaluations for the 4th and 5th year after treatment on. The clinical evaluation collects the information on biochemical and histological recidive (PSA). The HRQL includes: 1) a generic questionnaire SF-36; 2) the Functional Assessment of Cancer Therapy for cancer patients, General module and Prostate specific module (FACT-G and FACT-P); 3) the International Prostate Symptom Score (IPSS) of prostate symptoms; 4) the International Index of Erectile Function (IIES) of erectil disfunction; and 5) the Expanded Prostate Cancer Index Composite (EPIC), which measures localized cancer treatment’s impact.
Results: The first results of the 2 years follow-up study “Multicentric Spanish study of localized prostate cancer” (1) have been published recently. It is important to emphasize the fact that this is the first study on the impact of patient Quality of Life according to the different treatments conducted in Spain, and one of the first at the international level, (Radical Prostatectomy, brachytherapy and External Conformational Radiotherapy) which includes pre-treatment evaluation and follow-up of the patients evolution after two years, with repeated measures. This design allows to provide answers to the methodological problems which many previous studies presented. Most of those did not measure Quality of Life before the treatment even if this is fundamental in order to obtain conclusions, and some of them only presented the follow-up for only one year, which did not allow to detect modifications on the results at short or long term.
Among some of the results described in the article, the differences on the secondary effects of the medical treatments with the specific questionnaire Expanded Prostate Cancer Index Composite-EPIC (range from 0 to 100 from worst to better quality of life) stand out. The retropubic radical prostatectomy effects on the sexual function persist till the 2 years (EPIC sexual media 32,5 vs 43,6 and 49,8 in external radiotherapy and braquitherapy, respectively; p<0,001). The Generalized Estimation Equation models (GEE) created with the EPIC punctuations after two years as a dependent variable and adjusting it with the pre-treatment basal punctuation, the risk group, and the hormonal treatment show that patients having gone through a retropubic radical prostatectomy present results significatively inferior (worst) than those treated with braquitherapy in both the sexual nad the urinary incontinence dimensions (Beta= -20,4 and -14,01; p<0,001); the group of patients treated with external conformational radiotherapy presented worst results than the group treated with braquitherapy in the intestinal, sexual and hormonal EPIC (Beta= -3,55, -5,24 and -1,94; p<0,05).
In conclusion, secondary effects produced by prostatectomy in the sexual function and the urinary continence are important and persist, while patients treated with braquitherapy have recuperated similar levels to those previous to the treatment, after two years. Both the external conformational radiotherapy impact on the intestinal function and the braquitherapy one on the urinary irritation symptoms are moderate. Given the important differences between surgery and radiotherapy secondary effects shown in the study, it is important that the patient participated in the election of the treatment according to his own values and preferences.
Status: The justification on the importance of continuing with the study Hill 5 years is presented as the way to obtain survival results free of biochemical progression (a more brief period is not adequate to measure this parameter), results on the long term of the treatments secondary effects and their impact on patients HRQL.
Funding: Agència d’Avaluació de Tecnologia i Recerca Mèdica (AATRM), FIS