The news report: Friday, April 10, 2009

Today’s news reports deal with:

  • A comparative, single institution study of RALP vs RRP
  • Bone mineral density and osteoporosis in men treated with intermittent hormone therapy
  • Transdermal testosterone therapy in men with castration-resistant prostate cancer

In a separate report we have discussed the development of a pre-biopsy risk assessment nomogram that incorporates results from PCA3 testing.

Ficarra et al. have published data from a non-randomized, prospective, comparative study of all 208 patients undergoing robot-assisted laproscopic prostatectomy (RALP) or open retropubic radical prostatectomy (RRP) for clinically localized prostate cancer at an Italian institution between February 2006 and April 2007. There were 105 patients in the RRP and 103 patients in the RALP group. For RRP and RALP the median operative duration was 135 and 185 min, the intraoperative blood loss was 500 and 300 ml, and postoperative transfusion rates were 14 and 1.9 percent, respectively. There were post-operative complications in 9.7 of RRP patients and 10.4 percent of RALP patients.. Positive surgical margin rates in pT2 cancers were 12.2 and 11.7 percent for RRP and RALP, respectively. Forty-one percent of patients having RRP and 68.9 percent of those having RALP were continent at catheter removal. The 12-month continence rates were 88 percent after RRP and 97 percent after RALP, with the mean time to continence being 75 and 25 days, respectively. At the 12-month follow-up, 20/41 patients having bilateral nerve-sparing RRP (49% percent) and 52/64 having bilateral nerve-sparing RALP (81 percent) had recovery of erectile function. The authors conclude that, in their institution, RALP offers better results than RRP in terms of urinary continence and erectile function recovery, with similar positive surgical margin rates.

Spry et al. have completed a small, non-randomized, Phase II study designed to investigate changes in bone mineral density (BMD) and osteoporosis, over 3 years of intermittent androgen-suppression therapy. Patients in this study were enrolled between 1999 and 2002, and did not have metastatic bone disease at the time of enrollment. They were treated for 9 months with flutamide and leuprolide acetate, at which time therapy was stopped if their PSA levels were < 4 ng/ml. Hormone therapy was re-initiated when the PSA level exceeded the pretreatment level or was >20 ng/ml. Bone mineral density (BMD) in the hip and the spine was assessed at baseline; at completion of the initial treatment period; and at 1 and 2 years after initial treatment (POST period). They found that osteoporosis increased from 7 percent at baseline to 10 percent at 3 years. BMD declined a small amount after 9 months treatment. Subsequent BMD decline in the POST period was near to negligible. The BMD change in those remaining “off” therapy for 2 years (n = 20) was strongly associated with the level of testosterone recovery, which was less likely in older men.

Szmulewitz et al. have reported data from a randomized Phase I clinical trial of three different doses of transdermal testosterone in 15 older men with early-stage castration-resistant prostate cancer (CRPC). They state that testosterone is a feasible and reasonably well-tolerated therapy for men with early CRPC. However, there was no significant improvement in the patients’ quality of life, and there was only a borderline statistically significant improvement in hand-grip strength with treatment. The study was limited by sample size, a single arm, and variability of baseline patient characteristics. One patient was taken off study because of grade 4 cardiac toxicity, but there were no other grade 3 or 4 toxicities related to the study medication. One patient experienced symptomatic prostate cancer progression. Three patients demonstrated a decrease in PSA (the largest being 43 percent). The median time to progression was 9 weeks (range: 2-96 weeks), with no detectable difference between the three testosterone dose cohorts.

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