A prospective, 1-year trial using saw palmetto versus finasteride in the treatment of category III prostatitis/chronic pelvic pain syndrome.

PURPOSE: This study was designed to assess the safety and efficacy of saw palmetto or finasteride in men with category III prostatitis/chronic pelvic pain syndrome (CP/CPPS). MATERIALS AND METHODS: A prospective, randomized, open label, 1-year study was designed to assess the safety and efficacy of saw palmetto and finasteride in the treatment of men diagnosed with CP/CPPS. Patients were randomized to finasteride (5 mg once daily) or saw palmetto (325 mg daily) for 1 year. Patients were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index, individual domains (pain, urinary symptoms, quality of life and mean pain score) and the American Urological Association Symptom Score at baseline, 3, 6 and 12 months. RESULTS: A total of 64 consecutive men 24 to 58 years old (mean age 43.2) with a diagnosis of CP/CPPS were equally randomized to the 2 treatment arms. All 64 men had previously received antibiotics (duration of 3 to 93 weeks), 52 (82%) had been on alpha-blockade. There were 61, 57 and 56 patients evaluable at 3, 6 and 12 months, respectively. At 1 year mean total National Institutes of Health Chronic Prostatitis Symptom Index score decreased from 23.9 to 18.1 in the finasteride group (p <0.003), and from 24.7 to 24.6 in the saw palmetto arm (p = 0.41). In the finasteride arm the quality of life and pain domains were significantly improved at 1 year; however, urination was not. Adverse events included headache (3 cases) in the saw palmetto group and decreased libido (2 cases) in the finasteride group. At the end of the trial 13 of 32 (41%) and 21 of 32 (66%) opted to continue saw palmetto and finasteride, respectively. CONCLUSIONS: CP/CPPS treated with saw palmetto had no appreciable long-term improvement. In contrast, patients treated with finasteride had significant and durable improvement in all various parameters except voiding. Further studies are warranted to ascertain the mechanism and reproducibility of these effects in a placebo controlled trial.

Renal cancer and pregnancy in two different female cohorts.

PURPOSE: Although human renal cell carcinoma (RCC) is considered refractive to hormone therapy, this lesion can be induced in the Syrian hamster by exogenous estrogen. Human RCC also has been demonstrated to contain estrogen receptors. Since there are significant changes of estrogen levels during pregnancy, we wanted to investigate if there were any associations between the hormonal variations of pregnancy and renal cancer in women using two distinct cohorts. MATERIALS AND METHODS: We reviewed the charts of 57 females who presented for treatment of renal cancer. We assessed the size of each tumor radiologically and pathologically, the tumor stage, the number of pregnancies and/or abortions/miscarriages, age at menarche, and use of oral contraceptives. We compared this cohort to a sample of 985 nuns, and then reviewed the literature on the association of pregnancy, contraceptives and renal cell carcinoma. We used analysis of multiple variables (ANOVA) and the student's t test to determine any significance (p<0.05). RESULTS: Our age range was 39 to 67 years, with a mean of 51. The tumor volumes ranged from 9 cm(3) to 1500 cm(3), and the number of pregnancies ranged from 1 to 14. Menarche ranged from 8 to 14. We did not find any significant correlation between menarche or the number of pregnancies and the size or stage of renal cancers. However, our nun population did not reveal any incidence or illness from renal cell carcinoma over a 20 year review. CONCLUSIONS: Although our first cohort did not demonstrate any significant associations between the number of pregnancies or age at menarche and RCC, our second cohort and a review of the literature supports the notion that pregnancy is a risk factor for renal cell carcinoma.

PSA response to finasteride challenge in men with a serum PSA greater than 4 ng/ml and previous negative prostate biopsy: preliminary study.

OBJECTIVES: To determine, in a prospective study, the prostate-specific antigen (PSA) response to finasteride challenge in men with a serum PSA greater than 4 ng/mL who had undergone previous biopsy. Patients with a serum PSA level greater than 4 ng/mL who have undergone repeated prostate biopsy with prostate cancer (CaP) that was not detected present a diagnostic dilemma. The magnitude of PSA reduction after administration of finasteride has been well documented. In addition, doubling of the PSA value after 1 year of finasteride has been touted to be a more useful paradigm for diagnosing CaP than PSA alone. METHODS: Thirty-eight men with a baseline serum PSA level greater than 4 ng/mL and a normal digital rectal examination who had been previously biopsied a minimum of two times, with CaP not detected, were given 5 mg finasteride daily. The PSA level was measured at 6 and 12 months with repeat transrectal ultrasonography and biopsy (12 cores) performed at 1 year. Changes in prostate volume, serum PSA, PSA density, and the incidence of CaP at 1 year were assessed. RESULTS: The mean age of the group was 60.5 years (+/-7.6). For the group, the average number of previous biopsies performed was 2.9 (range 2 to 6). The baseline PSA level for the entire group was 6.32 ng/mL (+/-3.2), and the baseline prostate volume was 37.3 cm3 (+/-12.4). At 1 year, the PSA level had decreased to 3.73 ng/mL (-41.0%), and the prostate volume had decreased to 30.4 cm3 (-18.5%). In the 11 men (29%) in whom CaP was detected, the serum PSA decreased from 7.3 to 5.2 ng/mL (-28.8%) and the prostate volume decreased from 37.3 to 32.3 cm3 (-13.4%). CaP was detected in 0 of 10 men with a serum PSA decrease of 50% or higher, in 6 (32%) of 19 men with a PSA decrease between 33% and 50%, and in 5 (56%) of 9 men who had a PSA decrease of less than 33%. CONCLUSIONS: The data in this preliminary study suggest that the magnitude of change in serum PSA after 1 year of finasteride challenge may be useful in diagnosing CaP in patients with elevated PSA levels and prior negative prostate biopsy.