Claudio Teloken

Effect of dutasteride on the risk of prostate cancer

BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. METHODS In this 4-year, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, we compared dutasteride, at a dose of 0.5 mg daily, with placebo. Men were eligible for inclusion in the study if they were 50 to 75 years of age, had a prostate-specific antigen (PSA) level of 2.5 to 10.0 ng per milliliter, and had had one negative prostate biopsy (6 to 12 cores) within 6 months before enrollment. Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years. RESULTS Among 6729 men who underwent a biopsy or prostate surgery, cancer was detected in 659 of the 3305 men in the dutasteride group, as compared with 858 of the 3424 men in the placebo group, representing a relative risk reduction with dutasteride of 22.8% (95% confidence interval, 15.2 to 29.8) over the 4-year study period (P<0.001). Overall, in years 1 through 4, among the 6706 men who underwent a needle biopsy, there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group (P=0.81). During years 3 and 4, there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group, as compared with only 1 in the placebo group (P=0.003). Dutasteride therapy, as compared with placebo, resulted in a reduction in the rate of acute urinary retention (1.6% vs. 6.7%, a 77.3% relative reduction). The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia, except that in our study, as compared with previous studies, the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group (0.7% [30 men] vs. 0.4% [16 men], P=0.03). CONCLUSIONS Over the course of the 4-year study period, dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia. (ClinicalTrials.gov number, NCT00056407.)

The Effect of Dutasteride on the Usefulness of Prostate Specific Antigen for the Diagnosis of High Grade and Clinically Relevant Prostate Cancer in Men With a Previous Negative Biopsy: Results From the REDUCE Study

PURPOSE We assessed whether dutasteride enhances the usefulness of total prostate specific antigen for diagnosing clinically significant prostate cancer. MATERIALS AND METHODS The 4-year REDUCE study evaluated the efficacy and safety of 0.5 mg dutasteride daily for prostate cancer risk reduction in men with a prostate specific antigen of 2.5 to 10.0 ng/ml and a negative prostate biopsy. Specificity, sensitivity, and positive and negative predictive values of prostate specific antigen for the diagnosis of prostate cancer were assessed. RESULTS Final prostate specific antigen before biopsy and change from month 6 to final prostate specific antigen performed better for the diagnosis of Gleason score 7-10 tumors in men who received dutasteride vs placebo as assessed by the area under the ROC curves (0.700 vs 0.650, p = 0.0491; and 0.699 vs 0.593, p = 0.0001, respectively). Increases in prostate specific antigen were associated with a higher likelihood of biopsy detectable, Gleason score 7-10 and clinically significant (modified Epstein criteria) prostate cancer. Percentage decreases in prostate specific antigen from baseline to month 6 in the dutasteride arm did not predict prostate cancer overall or Gleason score 7-10 cancer. CONCLUSIONS In men with a previously negative prostate biopsy, prostate specific antigen performed better during the 4-year study as a marker of prostate cancer in men who received dutasteride vs placebo. The degree of prostate specific antigen increase after 6 months was a better indicator of clinically significant cancer in the dutasteride arm than in the placebo arm. Conversely, the initial decrease in prostate specific antigen in men taking dutasteride did not predict the likelihood of prostate cancer.

Diabetes mellitus is associated with subnormal serum levels of free testosterone in men

To evaluate the relationship between diabetes mellitus (DM) and serum levels of free (FT) and total (TT) testosterone.

Glycosylated haemoglobin levels and the severity of erectile function in diabetic men

To evaluate the association between the levels of glycosylated haemoglobin (HbA1c) and the severity of erectile dysfunction (ED) in men with diabetes mellitus (DM).

Experience with early catheter removal after radical retropubic prostatectomy

PURPOSE We tested the hypothesis that early catheter removal may be accomplished safely after radical prostatectomy. MATERIALS AND METHODS Cystography on postoperative day 4 or 5 in 42 of 67 consecutive patients who underwent radical retropubic prostatectomy revealed no extravasation in 30 and the urethral catheter was removed (group 1). The control group included 25 patients who did not undergo cystography, and the catheter was removed 14 days postoperatively (group 2). RESULTS Immediate and late continence was achieved in 14 (46.7%) and 25 (83.3%) cases in group 1, and in 8 (32%) and 22 (88%) cases in group 2, respectively (p>0.05). Catheterization was performed easily without any endoscopic or surgical procedure in 2 patients (6.7%) in group 1 who presented in urinary retention after catheter removal. Wound infection and pelvic abscess developed in 1 case (3.3%). There were no late complications. In group 2 urinary retention developed in 1 patient (4%), wound infection in 1 (4%) and hematuria in 1 (4%). Two patients (8%) had late vesical neck contracture at 4 and 10 months, respectively, which required urethrotomy in 1. In 1 patient (4%) a stricture in the anterior urethra was dilated. CONCLUSIONS Our study shows that early catheter removal may be accomplished safely in most patients after radical retropubic prostatectomy, and was not associated with a higher complication rate.

Usefulness of prostate-specific antigen (PSA) rise as a marker of prostate cancer in men treated with dutasteride: Lessons from the REDUCE study

Study Type – Prognostic (RCT)

Prosthetic Penile Infection: “Rescue Procedure” with Rifamycin

Penile prosthetic implantation is a successful procedure for the management of male erectile impotence. However, infection remains the most serious complication requiring removal of the device. Later reinsertion can be difficult due to fibrosis and a shortened penis. We present 3 cases of penile infection with Staphylococcus epidermidis in which a new penile prosthesis was placed after 72 hours of continuous irrigation of the corpora cavernosa with rifamycin. The procedure requires judicious selection of patients and a stable clinical status.

Persistence of müllerian duct derivative syndrome in 2 male patients with bilateral cryptorchidism.

The persistent müllerian duct syndrome represents a rare form of male pseudohermaphroditism secondary to anti-müllerian hormone deficiency. We describe 2 cases of phenotypically male postpubertal patients with a uterus and tubes. Both patients presented with bilateral cryptorchidism, 1 was seen for gynecomastia and 1 was seen for an abdominal mass that was found to be a testicular tumor.

A case of xanthogranulomatous cystitis

We report a case of xanthogranulomatous cystitis (XC) in a 76-year-old man who presented with painless hematuria and a bladder mass on imaging studies. Xanthogranuloma is a chronic inflammatory condition that most commonly involves the kidney. XC is a rare condition of still unknown aetiology with only about 20 cases reported to date. The gold standard treatment is surgical resection. Consideration should be given to this entity in the differential diagnosis of urinary bladder masses.

Effects of the chronic use of finasteride on testicular weight and spermatogenesis in Wistar rats

Objective To evaluate spermatogenesis in rats chronically exposed to finasteride, as the recent use of finasteride in young men to prevent hair loss has raised concerns about chronic use and fertility.