CCE and Prostate Cancer

AHRQ has announced a study of comparative clinical effectiveness for treatment of prostate cancer. The study states:

Localized prostate cancer is a priority condition for comparative effectiveness research, and affects approximately 200,000 men in the United States each year. This study will examine the comparative effectiveness of management strategies for localized prostate  cancer. Currently, few studies have directly compared the effectiveness of the different management  modalities, including newer radiation and surgical techniques which have been widely adopted without proven benefit over older techniques.

The objectives are stated as:

1.  To directly compare the disease-free survival and treatment-related morbidity in men with localized prostate cancer treated by open radical prostatectomy, minimally-invasive (including laparoscopic and robotic) prostatectomy, 3D conformal radiation therapy, intensity-modulated radiation therapy, proton radiation therapy, and brachytherapy.

2.  To directly compare the prostate-cancer specific and global quality of life (QOL) in men with localized prostate cancer treated by the same treatment modalities.

Part of the problem is defining localized cancer. It is not just the issue of invasiveness and tumor margins but it is more importantly the genetic makeup of the PCa cells. That is what should be addressed as well. Otherwise we are lumping all cancers together. It is not as if we have no knowledge of what to look for, we do. (See my book on Prostate Cancer Genomics, draft 2011).

The major defect we argue is that the genomic profile will be more critical than say a Gleason score and if this becomes part of the HHS CCE protocol, they are doing a study with little if any merit. They are failing to consider the key profiling elements.

It is reasons like this that we are seriously concerned about the incompleteness and potentially false conclusions drawn for studies of this type.