A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy.

Objectives: To study high-frequency 29 MHz transrectal side-fire micro-ultrasound (micro-US) for the detection of clinically significant prostate cancer (csPCa) on prostate biopsy, and validate an image interpretation protocol for micro-US imaging of the prostate. Materials and methods: A prospective randomized clinical trial was performed where 1676 men with indications for prostate biopsy and without known prostate cancer were randomized 1:1 to micro-US vs conventional end-fire ultrasound (conv-US) transrectal-guided prostate biopsy across five sites in North America. The trial was split into two phases, before and after training on a micro-US image interpretation protocol that was developed during the trial using data from the pre-training micro-US arm. Investigators received a standardized training program mid-trial, and the post-training micro-US data were used to examine the training effect. Results: Detection of csPCa (the primary outcome) was no better with the first-generation micro-US system than with conv-US in the overall population (34.6% vs 36.6%, respectively, P = .21). Data from the first portion of the trial were, however, used to develop an image interpretation protocol termed PRI-MUS in order to address the lack of understanding of the appearance of cancer under micro-US. Micro-US sensitivity in the post-training group improved to 60.8% from 24.6% (P < .01), while specificity decreased (from 84.2% to 63.2%). Detection of csPCa in the micro-US arm increased by 7% after training (32% to 39%, P < .03), but training instituted mid-trial did not affect the overall results of the comparison between arms. Conclusion: Micro-US provided no clear benefit over conv-US for the detection of csPCa at biopsy. However, it became evident during the trial that training and increasing experience with this novel technology improved the performance of this first-generation system.

Periurethral transurethral microwave thermotherapy for the treatment of benign prostatic hyperplasia: an interim 1-year safety and efficacy analysis using the thermatrx TMx-2000.

Transurethral microwave thermotherapy (TUMT) represents an accepted minimally invasive approach to the management of patients with benign prostatic hyperplasia (BPH). The TherMatrx TMx-2000 represents a further evolution in TUMT technique. This device uses periurethral transurethral microwave thermotherapy (P-TUMT) technology to directly target the BPH tissue adjacent to the prostatic urethra by using a catheter without a urethral-cooling surface. This article provides a technical review of the device and describes the results of a randomized, controlled multicenter study of P-TUMT for the treatment of symptomatic BPH. A discussion of the physiologic effects of P-TUMT is presented and compared to conventional TUMT. A comparison of P-TUMT to contemporary TUMT series in relation to efficacy and complications is also described. This study concludes that P-TUMT using the TherMatrx TMx-2000 device represents a minimally invasive, efficacious, and well-tolerated treatment for symptomatic BPH.

Upper tract transitional cell carcinoma following treatment of superficial bladder cancer with BCG.

Eighty-two consecutive patients treated with intravesical bacillus Calmette-Guerin (BCG) for recurrent superficial bladder tumors were evaluated for development of metachronous upper tract tumors (UTT). All patients had normal upper tract studies within three months of starting BCG treatment. With a median follow-up of sixty-two months (range 25 to 124), 11 patients (13.4%) were found to have UTT. The median interval between initiation of BCG therapy and diagnosis of the UTT occurrence was thirty-eight months (range 7 to 110). All patients were asymptomatic when the UTT was diagnosed. An abnormal surveillance intravenous or retrograde pyelogram was the method of diagnosis in 8 patients. Positive cytology alone directed diagnoses in 2 patients, and 1 patient was diagnosed in the workup of hematuria. Overall upper tract cytology was positive in 7 of 11 patients. Nephroureterectomy was performed in 9 patients and 2 had ureteroscopic biopsy and fulguration. Median follow-up after treatment of UTT was thirty-two months (range 3 to 80). UTT pathologic stage was Pa in 2 patients, P1 in 1 patient, and P2 or higher in 8 patients. Distant metastasis developed in 7 patients, 2 patients have recurrent superficial bladder tumors, and 2 patients are free of disease. The reported incidence in the literature for UTT tumors in patients with previous superficial or muscle invasive tumors ranges from 1.6 percent to 8.5 percent. The 13.4 percent incidence of UTT in the present study demonstrates the increased risk for patients in this series who were selected for BCG therapy. These risk factors include high tumor grade, associated carcinoma in situ (CIS), multiple tumors, T1 tumors, and failure of prior intravesical therapy. The fact that all patients were asymptomatic at the time of diagnosis of UTT emphasizes the importance of long-term periodic surveillance with radiographic and cytologic studies of the upper tracts for patients with similar risk factors.

Acute bilateral testicular torsion in the adolescent.

A case of acute bilateral testicular torsion in the adolescent is reported. This case reaffirms the need to perform bilateral scrotal exploration in cases of suspected torsion. Although it represents an extreme rarity, delay in exploration may have resulted in bilateral orchiectomy. The case also appears to be another example of intermittent testicular pain as a harbinger of impending torsion in a patient with the bell clapper deformity. Perhaps a more aggressive approach should be taken to explore patients surgically who present with intermittent scrotal pain.

Bacillus Calmette-Guerin therapy for high risk stage T1 superficial bladder cancer.

Numerous studies have shown bacillus Calmette-Guerin (BCG) to be an effective prophylactic and therapeutic agent for superficial transitional cell carcinoma of the bladder. The high grade stage T1 lesion treated by transurethral resection alone is reported to progress to muscle invasion in 30 to 50% of the patients. Therefore, some have recommended treatment with cystectomy. To evaluate BCG treatment of the stage T1 lesion we reviewed our results with a single or repeated 6-week course of the Armand-Frappier Pasteur strain BCG and compared them with those in the literature. We also compared these results with those of treatment of the stage TA lesion. We treated 30 stage T1 cancer patients who were described as at high risk based on the criteria of histology grade 3 in 24 and grade 2 in 6, carcinoma in situ present in 14 and positive urine cytology results 2 to 3 weeks after transurethral resection in 26. Followup ranged from 12 to 78 months, with a mean of 39 months. After a single 6-week course of BCG 14 patients (47%) had negative cytology and biopsy findings at 6 months. Also, 6 patients had conversion to negative cytology and biopsy results after a second 6-week course of treatment, for an over-all complete response rate of 66%. After the initial course of BCG 4 patients had progression to cystectomy: 1 for muscle invasion and 3 for a persistent stage T1 lesion. They had no evidence of disease 12 to 60 months postoperatively. One patient had progression to metastasis after a second course of BCG. Therefore, the over-all progression rate to cystectomy or metastasis was 17% (5 of 30 patients). All 5 patients were among the 16 who failed to achieve a complete response after the initial course of BCG. In conclusion, our experience and that of others demonstrate that BCG therapy is an effective initial treatment of stage T1 disease to prevent progression and recurrence, and to preserve bladder function. Close monitoring will identify those nonresponders who require surgical intervention.