German prostate cancer study
The German Prostate Cancer Study PREFERE (“Preference-based randomized study to evaluate four treatment modalities for prostate cancer with low and early intermediate risk”) was a large-scale oncological long-term study on the treatment of prostate cancer . Men with a low or medium risk of developing prostate cancer should be assigned to one of four treatment options and observed over a longer period of time.
The German Cancer Aid Foundation and the statutory and private health insurances pledged 25 million euros to finance the investigation, which was originally planned from 2013 to 2030 . In December 2016, the funding was stopped early because the number of enrolled patients was too low.
Goal and mission
In the PREFERE study, all four common treatment methods for early forms of prostate cancer were compared for the first time:
- surgical removal of the prostate (radical prostatectomy)
- External radiation ( percutaneous radiation therapy)
- Irradiation with implanted radiation sources (permanent seed implantation or brachytherapy)
- Active monitoring (therapy only if the tumor progresses)
All four options are recommended in the German treatment guidelines. However, in the opinion of those responsible for the study, earlier studies did not yet provide a sufficient answer as to which variant is most useful and which is least harmful. The Prefere study should clarify this question.
execution
A total of 7600 patients were to be recruited for the long-term study between 2013 and 2017 and randomly assigned to one of the four therapy options in around one hundred test centers.
The prerequisite for participation in the study was that the prostate cancer was not yet very advanced, had just been diagnosed and had not yet been treated. Each participant could deselect up to two options before the randomization. The patients were treated in certified cancer centers. The primary endpoint of the study was what is known as prostate cancer-specific survival. In addition to measurements that relate specifically to prostate cancer, measurements of various aspects of quality of life should be carried out during the entire term with a follow-up period of at least 13 years.
If a patient was interested in participating in the study, his treating urologist referred him to one of the participating study centers. There the doctor gave him detailed information about the study and the four possible therapy options. According to the decision of the person concerned, the patient should be cared for for a period of at least 13 years in cooperation with his resident urologist and by a study center. The prerequisite for participation in the study was that the prostate cancer was not yet very advanced, had just been diagnosed and had not yet been treated.
Quality of treatment
Clinics that participated in the research as study centers had to meet certain quality requirements such as a minimum number of prostate cancer treatments per year. They also had to be able to perform both the surgical treatment of the carcinoma and the two different options of radiation therapy . The centers also had to undergo a quality assurance procedure. As a result, patients should be able to rest assured that they were receiving the best possible treatment as part of the PREFERE study. Another advantage for patients was that particularly experienced and specialized pathologists also examined the participants' prostate tissue, which was taken during the biopsy , again. This second assessment, which is not part of the standard care, provided a higher degree of certainty in the diagnosis .
history
The urologist Michael Stöckle from the University Hospital Homburg / Saar and the radiation therapist Thomas Wiegel from the University Hospital Ulm were in charge of the PREFERE study . The following were involved in the study: the German Society for Urology , the German Society for Radiation Oncology (radiation therapy), the Professional Association of German Urologists , the German Cancer Society and the German Association for Prostate Cancer Self-Help .
The preparation of the study began in 2012. When it started in autumn 2013, over 60 hospitals nationwide were already participating as study centers. Thanks to an almost nationwide offer, men with a localized prostate cancer throughout Germany had the opportunity to take part in PREFERE and be treated in a hospital in their vicinity.
By January 2016, a total of around 350 subjects had been treated. The required number of around 2000 participants per year was thus far short of being achieved. The study was therefore discontinued at the end of 2016. It was emphasized that the termination of the PREFERE study would not have any disadvantages for the further care of the 343 patients who had previously decided to participate.
criticism
In the run-up to the study it was u. a. criticizes that the goals of the study would not be achievable, as the targeted recruitment figures are unrealistic. This criticism was rejected by the study director in a public statement. Criticism was also expressed that there was already sufficient scientific evidence to view active monitoring in this patient group as the best option and that the study therefore posed a question that has already been answered.
Individual evidence
- ↑ Prostate cancer study "Prefere" will not be continued. Accessed December 8, 2016
- ↑ Too few men: urologists argue about largest prostate cancer study . Spiegel online from March 25, 2015
- ↑ Interdisciplinary guideline of quality S3 for early detection, diagnosis and therapy of the various stages of prostate cancer. Short version 3.1 - 2nd update - October 2014 AWMF - Register - number 043 / 022OL . ( Memento of the original from March 22, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Retrieved January 21, 2016. PDF file (1.3 MB)
- ^ Directory of the study center, September 2013
- ↑ German prostate cancer study started successfully . Press release on the website of the IIKK eV, September 24, 2013. Accessed on January 21, 2016.
- ↑ "The German man does not like to be recruited for a study" . Süddeutsche Zeitung from January 19, 2016
- ^ Ian F. Tannock, Professor of Medical Oncology (Toronto): Statement on the PREFERE study. December 11th, 2012. Published on the website of the Men's Health Foundation . PDF file
- ↑ Thomas Wiegel u. a .: PREFERE - the German prostate cancer study. Questions and claims about starting your studies in January 2013 . In: Urologe , 2013, Volume 52, pp. 427–441. doi : 10.1007 / s00120-013-3156-y
- ^ C. Schäfer, L. Weisbach: PREFERE - open questions . In: Urologe , 2014, Volume 53, pp. 384–386. doi : 10.1007 / s00120-013-3258-6
