The daily news update: Wednesday, March 11, 2009

Reports today deal with:

  • 5α-Reductase inhibitors and other agents in prevention of prostate cancer
  • Expansion of patient eligibility for an Ablatherm HIFU trial in the USA
  • Osteoprotegerin in development and progression of bone metastases
  • Chemo-immunotherapy for treatment of metastatic disease

Rittmaster et al. have reviewed available data on the use of 5α-reductase inhibitors (like finasteride and dutasteride) and other agents to reduce the risk for prostate cancer. (We assume that this article was submitted for publication some time before the publication of the recent AUA/ASCO guidelines on the use of 5α-reductase inhibitors to preventr prostate cancer.) Other classes of drug discussed in this article that may also have such potential include statins (e.g., simvastatin), cyclooxygenase-2  or COX-2 inhibitors (e.g., celecoxib), selective estrogen receptor modulators or SERMs (e.g., raloxifene), and some dietary supplements.

EDAP TMS has received approval from the U.S. Food and Drug Administration (FDA) to amend the protocol for the ENLIGHT trial — its  ongoing clinical study of high intensity focused ultrasound or HIFU  (using the company’s Ablatherm equipment) for the treatment of patients with localized prostate cancer. Changes in the study protocol now allow a minimum patient age of 50 years (down from the former 60 years of age); the addition of up to three more clinical trial sites in the USA; replacement of the required 5-day follow-up visit with a telephone call consultation; and inclusion of patients currently being treated with α-blockers or saw palmetto for benign prostatic hyperplasia. These changes to the study protocol are intended to accelerate recruitment in this study, although it is worth noting that no patient with a Gleason score of > 6 is eligible for participation in this trial, which makes it questionable how many of these patients over (say) 70 years of age actually need treatment at all.

Fili et al. have reviewed the potential role of osteoprotegerin (OPG), a member of the tumor necrosis factor (TNF) receptor family, in the development and progression of bone metastases.

Rosková et al. have reported on the clinical use of a combination of chemotherapy and immunotherapy in the treatment of patients with metastatic prostate cancer in the Czech Republic. They report that, because of the high levels of circulating CD4+, CD25+ regulatory T cells (“Tregs”) in their patients, they treated patients first with metronomic cyclophosphamide and then started regular vaccinations with dendritic cells (DCs) loaded with killed prostate cancer cells. Palliative chemotherapy with docetaxel was also maintained to reduce the tumor cell burden. According to their data, this form of combined chemo-immunotherapy resulted in notable improvements in the clinical and laboratory presentation of the patients and in decreases in patient PSA levels of > 90 percent.

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