More from the European comparative effectiveness research front

Apparently the German health system is to initiate a large trial to investigate the comparative effectiveness of four different treatments for men initially diagnosed with low-risk prostate cancer, starting this year.

This trial is an outcome of German studies that have led them to conclude that there is insufficient data to confirm the benefits of permanent seed implantation (brachytherapy) as compared to more traditional first-line treatment options.

The new study is going to compare management with:

  • Permanent seed brachytherapy
  • Radical prostatectomy
  • External beam radiation therapy
  • Active surveillance

for men who clearly meet specific criteria for low-risk prostate cancer. The criteria for eligibility for the active surveillance arm are more stringent (e.g., Gleason score of 6 or lower) that the criteria for eligibility in the other three arms of the trial (e.g, Gleason score of 3 + 4 = 7 or lower).

Those who have a good grasp on German can read the full details of the rational for the study and the actual study design.  This is going to be a large and complex study, requiring (as far as we can tell) in excess of 6,0o0 patients, who will need to be followed for many years. It is also important to note that this is not a randomized study. Assuming they meet appropriate enrollment criteria, they will have a signifciant degree of choice as to their initial therapy and/or wht type of therapy they have if they move from active surveillance to invasive treatment.

What the “New” Prostate Cancer InfoLink sees as being important here is the fact that European health systems, clinicans, and investigators are increasingly willing to take on some of the toughest questions facing the prostate cancer: are there real differences between the outcomes of the differing major treatments that can be demonstrated in comparative, head-to-head clinical trials?

It will be interesting to see just how fast the investigators can accrue the large number of patients necessary for this trial.

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