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Far below expectations: study on prostate cancer therapy canceled


Premature end for world's largest prostate cancer study
The world's largest prostate carcinoma study was launched in Germany around three and a half years ago. The investigation has now ended prematurely. The number of enrolled patients fell far short of expectations. The initiators of the study also blamed doctors for the failure.

Most common cancer in German men
Prostate cancer is the most common cancer in German men and the third most common cause of cancer death. According to estimates by the Robert Koch Institute (RKI), far more than 60,000 men in Germany contract a malignant tumor of the prostate gland every year. Over 12,000 die from prostate cancer each year. The world's largest study on this type of cancer has now failed. Not enough patients were found for the examination.

World's largest investigation terminated prematurely
Research in the area of ​​prostate cancer has made tremendous progress in recent years. For example, British researchers have found that certain genes play a major role in the development of prostate cancer. A few months ago, other scientists reported a new drug that would better treat aggressive prostate cancer.

But the world's largest prostate carcinoma study has now been canceled. "The German Cancer Aid, the statutory health insurance companies and private health insurance companies will not continue the PREFERE study to evaluate the common treatment options for early forms of prostate cancer and will end the study funding as of December 31, 2016 because the number of enrolled patients fell far short of expectations" , it says in a message.

Great expectations
In the long-term study that started three and a half years ago and was originally planned until 2030, great expectations were placed at the beginning. In the large study, the four common therapies for prostate cancer were to be compared and evaluated for their effectiveness, side effects and effects on the quality of life of those affected:

Surgical removal of the prostate (radical surgery), radiation from outside, active monitoring with regular checks and treatment of the tumor by radiation sources permanently placed in the prostate, the so-called brachytherapy.

This should find the best individual therapy for those affected. A total of 25 million euros were planned for the study.

Instead of 7,000, only 343 study participants
Well over 7,000 patients should take part in the study, but only 343 volunteers reported. The "study project did not meet the expectations regarding feasibility, especially the recruitment rate, on which the decision to fund the study was based", said the German Cancer Aid.

"In addition, recently published data from an English study (ProtecT study), according to the study directors, would have made fundamental changes in the study design necessary," said the experts. So it remains unclear which of the four options "benefits patients with early stage prostate cancer the most".

Urologists are made responsible for the failure
The initiators of the study also made the urologists jointly responsible for ending the investigation. As stated in the communication, there were indications that a quarter of the established urologists, who are usually the first point of contact for the patient, are not willing to participate in the "prefere study".

“Apparently the patients could not be adequately conveyed that the question of the best therapy is scientifically unanswered, that is, the recommendation of one is unfounded over the other. Otherwise the patients would have followed the logic that randomization in any case does not mean a disadvantage, but it does gain knowledge, ”explained Prof. Dr. Jürgen Fritze from the Association of Private Health Insurance.

Registered patients benefited
The study sponsors were disappointed with the termination of the study. "Unfortunately, this leaves the question of the best therapy for low-risk prostate cancer unanswered," said the chairman of the Federal Joint Committee (G-BA), Prof. Josef Hecken.

But despite the early termination of studies, the study also yields important findings. For example, the second assessment of the tissue samples has significantly reduced the risk of over- or under-therapy for those affected. According to Cancer Aid, patients enrolled in the past three and a half years have benefited from this advantage. (ad)

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Video: Stereotactic Body Radiotherapy for Prostate Cancer (October 2021).