A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer.

BACKGROUND: Pomegranate juice has been associated with PSA doubling time (PSADT) elongation in a single-arm phase II trial. This study assesses biological activity of two doses of pomegranate extract (POMx) in men with recurrent prostate cancer, using changes in PSADT as the primary outcome. METHODS: This randomized, multi-center, double-blind phase II, dose-exploring trial randomized men with a rising PSA and without metastases to receive 1 or 3 g of POMx, stratified by baseline PSADT and Gleason score. Patients (104) were enrolled and treated for up to 18 months. The intent-to-treat (ITT) population was 96% white, with median age 74.5 years and median Gleason score 7. This study was designed to detect a 6-month on-study increase in PSADT from baseline in each arm. RESULTS: Overall, median PSADT in the ITT population lengthened from 11.9 months at baseline to 18.5 months after treatment (P < 0.001). PSADT lengthened in the low-dose group from 11.9 to 18.8 months and 12.2 to 17.5 months in the high-dose group, with no significant difference between dose groups (P = 0.554). PSADT increases >100% of baseline were observed in 43% of patients. Declining PSA levels were observed in 13 patients (13%). In all, 42% of patients discontinued treatment before meeting the protocol-definition of PSA progression, or 18 months, primarily due to a rising PSA. No significant changes occurred in testosterone. Although no clinically significant toxicities were seen, diarrhea was seen in 1.9% and 13.5% of patients in the 1- and 3-g dose groups, respectively. CONCLUSIONS: POMx treatment was associated with ≥ 6 month increases in PSADT in both treatment arms without adverse effects. The significance of this on-study slowing of PSADT remains unclear, reinforcing the need for placebo-controlled studies in this patient population.

The treatment of gross hematuria secondary to prostatic bleeding with finasteride.

PURPOSE: We evaluate the use of finasteride to control gross hematuria secondary to prostatic bleeding. MATERIALS AND METHODS: We reviewed retrospectively 42 patients treated with finasteride to treat gross hematuria. RESULTS: There were 28 evaluable patients who had taken finasteride for at least 6 months to control gross hematuria and hematuria ceased in 25 (91%). In 1 patient clot retention developed requiring transurethral resection of the prostate and 2 patients had 1 or more minor episodes of bleeding that resolved spontaneously. CONCLUSIONS: Finasteride appears to be an effective agent for controlling gross hematuria secondary to prostatic bleeding.

Is heparin contraindicated in pelvic lymphadenectomy and radical prostatectomy?

PURPOSE: We initiated a prospective study to verify or refute the complications of lymphocele formation and excessive blood loss associated with heparin prophylaxis in pelvic lymphadenectomy and radical prostatectomy. MATERIALS AND METHODS: A prospective study was completed on 579 men undergoing pelvic lymphadenectomy usually in association with radical prostatectomy. Patients were assigned to group 1 (given preoperative and postoperative subcutaneous heparin) and group 2 (no heparin). All patients were evaluated 2 to 3 weeks after surgery with ultrasound for pelvic lymphocele. RESULTS: There was no statistically significant difference in the number or size of pelvic lymphoceles or blood loss in group 1 versus group 2. CONCLUSIONS: The use of heparin prophylaxis to prevent thromboembolic complications in conjunction with pelvic lymphadenectomy and radical prostatectomy is not associated with increased blood loss or increased rate of lymphocele formation.

Antibiotic prophylaxis in ultrasound guided transrectal prostate biopsy.

PURPOSE: A retrospective review of a large group of transrectal ultrasound guided biopsies was performed to determine the symptomatic urinary tract infection rate associated with a consistent and defined antibiotic prophylaxis regimen. MATERIALS AND METHODS: A total of 4,439 biopsies was performed using an 18 gauge needle with ultrasound guidance. Patients were treated with 500 mg. ciprofloxacin twice daily for 8 doses beginning the day before biopsy. RESULTS: Of 5 symptomatic urinary tract infections noted 3 were complicated. CONCLUSIONS: These data demonstrate the low infection rate associated with this prophylaxis regimen.

The incidence and management of rectal injury associated with radical prostatectomy in a community based urology practice.

PURPOSE: We assessed the use of combination bowel preparation before radical prostatectomy. MATERIALS AND METHODS: We reviewed 533 radical prostatectomies performed from 1984 to 1994. All patients underwent preoperative combination bowel preparation. The incidence, management and sequelae of rectal injury were determined. The literature addressing the management of rectal injuries was reviewed. RESULTS: Rectal injury occurred in 8 patients (1.5%). Injury was recognized intraoperatively and repaired primarily in 6 cases, and repair included colostomy in 2. Injury was recognized postoperatively as recto-urinary fistula in 2 cases and initial management was conservative. No fistula closed with conservative management. There were no pelvic abscesses and no deaths. CONCLUSIONS: Combination bowel preparation permits safe closure of rectal injury at radical prostatectomy without the necessity of routine colostomy. In the event of recto-urinary fistula, conservative management is not warranted.

Bladder necrosis secondary to pelvic artery embolization: case report and literature review.

Bladder necrosis is a rare entity in the urological literature. We report a case of bladder necrosis secondary to pelvic artery embolization to control intractable hemorrhage from a pelvic fracture.

The use of prostate specific antigen and prostate specific antigen density in the diagnosis of prostate cancer in a community based urology practice.

Since 1989 we have used serum prostate specific antigen (PSA) levels as an indication for ultrasound guided systematic biopsies of the prostate. Realizing that the PSA level in part reflects prostatic glandular epithelial volume, we reviewed the accumulated data on our last 2,340 biopsies to determine if the quotient of PSA and prostatic volume, prostate specific antigen density, provided any further diagnostic information. There were evaluable data for 2,020 patients. Prostate specific antigen density levels are shown to have a strong correlation with the diagnosis of prostate cancer and provide a more reliable indication for ultrasound guided biopsy of the prostate than PSA alone.

The syndrome of inappropriate secretion of antidiuretic hormone following carotid endarterectomy. A case report and review of the literature.

The syndrome of inappropriate secretion of antidiuretic hormone (SIADH) has not been reported as a complication of carotid endarterectomy. We present a case of SIADH in a patient who underwent carotid endarterectomy four weeks after a completed stroke with good recovery. The presence of this syndrome was associated with the development of a neurological deficit.

Desmopressin control of surgical hemorrhage secondary to prolonged bleeding time.

Desmopressin has been used as a hemostatic agent in numerous hematological and nonhematological diseases. We report a case of surgical hemorrhage secondary to prolonged bleeding time of unexplained origin controlled with desmopressin.

Sarcoidosis and testicular tumors.

A thirty-five-year-old white man presented with hilar adenopathy and elevated alpha-fetoprotein after retroperitoneal node dissection and chemotherapy for mixed embryonal seminomatous testicular tumor. A biopsy completed by mediastinoscopy demonstrated sarcoidosis.

Importance of acid phosphatase in response criteria for prostate cancer.

The role of acid phosphatase in the definition of response to treatment for prostate cancer is unclear. To better define its predictive value, especially regarding survival rate, we reviewed the clinical course of 76 men with Stage D2 prostate cancer who were treated with combination chemotherapy.

Cystic hygroma of the breast.

Cystic hygroma is a common benign lymphatic tumor that presents at birth or during infancy. We report an unusual case of a cystic hygroma of the breast, which was discovered in a 49-year-old woman on screening mammography.