Urology
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Randomized Controlled Trial Clinical Trial
Chemoprevention trials in men with prostate-specific antigen failure or at high risk for recurrence after radical prostatectomy: Application to efficacy assessment of soy protein.
This article discusses the basic elements of chemoprevention trial designs using cohorts of men following radical prostatectomy who either have prostate-specific antigen (PSA) failure indicative of recurrence or are at high risk for recurrence (positive surgical margins, extracapsular extension, seminal vesicle invasion, positive lymph nodes, Gleason score of greater than or equal to 8, preoperative serum PSA less than 20 ng/mL). Two ongoing randomized, double-blind, placebo-controlled clinical trials with soy protein as intervention in these 2 populations are described. ⋯ In the trial with men with PSA failure (PSA 0.1 to 2.0 ng/mL), participants received treatment for 8 months and the primary endpoint is rise in PSA over time. The strengths and limitations of these designs are discussed and interim experience using studies with soy protein as the intervention agent are summarized.
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Randomized Controlled Trial Clinical Trial
Prostate-specific antigen-based early detection of prostate cancer--validation of screening without rectal examination.
The evaluation of the screening procedures for prostate cancer (PCa) was a part of the protocol of the European Randomized Study of Screening for Prostate Cancer (ERSPC), section Rotterdam, The Netherlands. We sought to establish an improved strategy for the early detection of PCa using a prostate-specific antigen (PSA) cutoff of 3.0 ng/mL or greater as the only indication for prostate biopsy with omission of the digital rectal examination (DRE). ⋯ Lowering the biopsy indication to a PSA cutoff of 3.0 ng/mL or greater without a DRE improved the positive predictive value from 18.2% to 24.3%. The number of biopsies necessary to detect 1 case of PCa accordingly changed from 5.2 to 3.4. The overall characteristics of the cases detected at that PSA cutoff differed very little from those detected with the regimen based on PSA, DRE, and transrectal ultrasound.
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Randomized Controlled Trial Clinical Trial
Analgesia during extracorporeal shock wave lithotripsy using the Medstone STS lithotriptor: a randomized prospective study.
To investigate and compare the effectiveness of three analgesic protocols for pain management during extracorporeal shock wave lithotripsy (ESWL) in a prospective, randomized clinical trial. ⋯ The use of KT was safe and effective for premedication before ESWL; patients receiving KT before ESWL reported lower pain scores and required less supplemental analgesia requirement than those who received MS or Emla; however, the differences were not statistically significant. Patients receiving Emla recorded the highest pain scores. Patients with ureteral stents had lower pain scores and required less supplemental analgesia.
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Randomized Controlled Trial Comparative Study Clinical Trial
Does androgen suppression enhance the efficacy of postoperative irradiation? A secondary analysis of RTOG 85-31. Radiation Therapy Oncology Group.
To evaluate the effect of immediate androgen suppression in conjunction with standard external beam irradiation (RT) versus RT alone on a group of men after prostatectomy who had indications for adjuvant treatment. ⋯ Patients with prostate cancer and indications for postoperative RT should be considered for combined RT and hormonal manipulation. Because statistically significant advantages for this experimental approach could not be defined for all end points studied (in particular, overall survival), efforts should be made to enroll these patients in the recently activated RTOG trial (96-01) comparing RT plus placebo to the combination of RT plus Casodex in the postoperative setting.
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Randomized Controlled Trial Clinical Trial
Neoadjuvant and adjuvant alpha-blockade improves early results of high-energy transurethral microwave thermotherapy for lower urinary tract symptoms of benign prostatic hyperplasia: a randomized, prospective clinical trial.
Improved long-term results with respect to symptoms, voiding function, and quality of life (QOL) in patients with lower urinary tract symptoms (LUTS) of benign prostatic hyperplasia (BPH) are achieved with targeted high-energy transurethral microwave thermotherapy (TUMT) compared with alpha-blocker treatment alone. However, maximal improvement after TUMT is not attained until 3 to 6 months after treatment. Measures to provide earlier symptom relief and improved voiding function and QOL would add to the clinical utility of TUMT. The objective of the present study was to determine whether neoadjuvant and adjuvant alpha-blockade is capable of accelerating a post-TUMT decrease in LUTS of patients with BPH. ⋯ Neoadjuvant and adjuvant alpha-blocker treatment results in significantly greater early symptom reduction and QOL score improvement after TUMT, adding to the clinical utility of this minimally invasive treatment modality. In addition, post-TUMT complications such as urinary retention may be reduced.