Objectives: To clarify the role of phosphodiesterase type 5 ( PDE 5) inhibitors in post‐prostatectomy penile rehabilitation ( PPPR ). To compare nightly and on‐demand use of PDE 5 inhibitors after nerve‐sparing minimally invasive radical prostatectomy ( RP ). Patients and Methods: We conducted a single‐institution, double‐blind, randomized controlled trial of nightly vs on‐demand 50‐mg sildenafil citrate after nerve‐sparing minimally invasive RP . A total of 100 preoperatively potent men, aged <65 years, with scores on the E rectile F unction domain of the I nternational I ndex of E rectile F unction ( IIEF‐EF ) ≥26, underwent nerve‐sparing surgery. The patients were randomized to either nightly sildenafil and on‐demand placebo (nightly sildenafil group), or on‐demand sildenafil and nightly placebo (on‐demand sildenafil group; maximum on‐demand dose six tablets/month) for 12 months. Patients then underwent a 1‐month washout period. Validated measures of erectile function ( IIEF‐EF score and the E xpanded P rostate C ancer I ndex C omposite [ EPIC ]) were compared between treatment groups over the entire 13‐month time course, using multivariable mixed linear regression models. Results: The treatment groups were well matched preoperatively (mean age 54.3 vs 54.6 years, baseline IIEF‐EF score 29.4 vs 29.3, for the nightly vs the on‐demand sildenafil groups, respectively). No significant differences were found in erectile function between treatments (nightly vs on‐demand sildenafil) at any single timepoint after RP , after adjusting for potential confounding factors. When evaluated over all timepoints simultaneously, no significant effects of treatment group (nightly vs on‐demand sildenafil) were found on recovery of potency, as assessed by absolute IIEF‐EF scores ( P = 0.765), on percentage of men returning to an IIEF‐EF score >21 ( P = 0.830), or on IIEF‐EF score recovery to a percentage of baseline value ( P = 0.778). When evaluated over all timepoints simultaneously, no significant effects of treatment group were found on secondary endpoints such as assessment of potency (including EPIC item 59 response ‘erections firm enough for intercourse’), attempted intercourse frequency or confidence. Conclusions: Erectile recovery up to 1 year after RP does not differ between previously potent men who use sildenafil nightly compared to on‐demand. This trial does not support chronic nightly sildenafil as being any better than on‐demand sildenafil for use in penile rehabilitation after nerve‐sparing minimally invasive RP .
We have previously shown that endoglin (CD105) is upregulated in prostatic fluid of men with large volume prostate cancer. We chose to assess endoglin levels in urine and serum from men with prostate cancer or at increased risk for the disease: Urine samples were collected after digital rectal examination (DRE) from 99 men whose cancer status was confirmed by biopsy, and serum samples were collected from 20 men without prostate cancer at low risk for the disease and from 69 men diagnosed with prostate cancer that subsequently underwent radical prostatectomy (30 pT2, 39 pT3). Endoglin levels were assessed by ELISA. Urinary endoglin was elevated in men with biopsy‐positive prostate cancer compared to biopsy‐negative men (p = 0.0014). Urinary endoglin levels in men with prostate cancer correlated with radical prostatectomy tumor volume. The area under the receiver operating characteristic (ROC) curve was 0.72 for urinary endoglin and 0.50 for serum prostate‐specific antigen (PSA; sensitivity for cancer detection 73%, specificity 63%). There were no differences in serum endoglin between normal and cancer cases, but there were increases in serum endoglin in non‐organ confined (NOC, pT3+) versus organ‐confined (OC, pT2) cases (p = 0.0004). The area under the ROC curve was 0.75 for serum endoglin and 0.63 for PSA for predicting NOC status, with a sensitivity of 67% and a specificity of 80%. In conclusion, elevations in post‐DRE urinary endoglin suggest there may be value in further studying endoglin as a urinary biomarker of prostate cancer. Endoglin levels in both urine and serum may aid in prostate cancer detection and prognostication.
1 January 2014 in Urologic Oncology: Seminars and Original Investigations