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Far behind expectations study for treatment of prostate cancer discontinued
About three and a half years ago, the world's largest study on prostate carcinoma was launched in Germany. Now the investigation has ended prematurely. The number of enrolled patients fell far short of expectations. The initiators of the study also blame medical professionals 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), more than 60,000 men in this country suffer from a malignant tumor of the prostate gland every year. Over 12,000 die of prostate cancer each year. Now, the world's largest study on this cancer has failed. Not enough patients have been found for the examination.
Prostate cancer is the most common cancer in men in Germany. There are several ways to treat the disease. A study comparing and evaluating the different therapies has now been discontinued early. (Image: Kateryna_Kon / fotolia.com) World's largest investigation prematurely aborted
Research on 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. Other scientists reported a few months ago on a new drug that allows better treatment of aggressive prostate cancer.
But the world's largest study on prostate cancer has now been discontinued. "German Cancer Aid, statutory health insurances and private health insurers will discontinue the PREFERE trial evaluating common treatment options for prostate cancer onset and will discontinue study funding by 31 December 2016 because the number of enrolled patients has fallen far short of expectations" it says in a message.
Great expectations
The long-term study, which started three and a half years ago and was originally planned for 2030, had great expectations at the beginning. For the first time, the large-scale study aimed to compare and evaluate the four major prostate cancer therapies for their effectiveness, side effects, and their impact on the quality of life of those affected:
The operative removal of the prostate (radical surgery), the external radiation, the active monitoring with regular controls and the treatment of the tumor by permanently placed in the prostate radiation sources, the so-called brachytherapy.
This should be 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
More than 7,000 patients were expected to participate in the study, but only 343 subjects reported. The "study project has failed to meet the expectations of feasibility, in particular the recruitment rate underlying the decision to sponsor the study," said the German Cancer Aid.
"In addition, recently published data from an English study (ProtecT study), according to the study's own statements, would have necessitated fundamental changes in the study design," say the experts. It therefore remains unclear which of the four options "most benefit patients with prostate cancer at an early stage".
Urologists are made responsible for the failure
The initiators of the study also made the urologists co-responsible for ending the investigation. According to the communication, there were indications that a quarter of resident urologists, who are usually the first port of call for the patient, are unwilling to participate in the Prefere study.
"The patients could apparently not be sufficiently taught that the question of the best therapy is scientifically unanswered, so that the recommendation of one over the other therapy is unfunded. Otherwise, the patients would have followed the logic that randomization would not be a disadvantage at all, but gain recognition, "explained Prof. Dr. med. Jürgen Fritze from the Association of Private Health Insurance.
Registered patients have benefited
The sponsors were disappointed by the discontinuation of the study. "Unfortunately, the question of the best therapy for low-risk prostate cancer remains unclear," said the chairman of the Federal Joint Committee (G-BA), Prof. Josef Hecken.
However, despite the early termination of the study, important findings also result from the study. For example, the second evaluation of the tissue samples has significantly reduced the risk of over or under therapy for those affected. The patients enrolled in the last three and a half years have benefited from this benefit, according to the Cancer Aid. (Ad)