Phase II study of intravesical therapy with AD32 in patients with papillary urothelial carcinoma or carcinoma in situ (CIS) refractory to prior therapy with bacillus Calmette-Guerin (E3897): a trial of the Eastern Cooperative Oncology Group.

OBJECTIVE: To assess the safety and effectiveness of AD32, a doxorubicin analogue with little systemic exposure when administered intravesically, in patients with recurrent or refractory superficial urothelial carcinoma (formerly called transitional cell carcinoma [TCC]), or carcinoma in situ (CIS), who have failed prior BCG-based immunotherapy. METHODS: Eligible patients received six weekly doses (800 mg) of intravesical AD32 and were evaluated at 12-week intervals for 24 months or until date of worsening disease. Primary analysis was the proportion of all patients recurrence-free at 12 months. Treatment-related and GU-specific toxicities were also examined. All participating institutions submitted the protocol for Institutional Review Board (IRB) approval. RESULTS: The study was halted due to unavailability of study drug after accrual of 48 of a planned 64 patients; 42 were included in the analysis. Of these, 28 (67%) were still alive after median follow-up of 61.1 months. Of 21 TCC patients, 18 (85.7%) experienced disease recurrence (median time to recurrence, 5.3 months). Of the 5 CIS patients with complete response (CR), 3 (60%) experienced disease recurrence; (median time to recurrence, 37.3 months). Recurrence-free rates at 12 and 24 months were 20% (90% CI, 7.8%, 36.1%) and 15% (90 CI, 4.9%, 30.2%), respectively, for patients with TCC and 80% (90% CI, 31.4%, 95.8%) at both intervals for CIS patients with CR. Infection was the most common treatment-related toxicity; no grade 4 or higher toxicity was observed. The most common GU-specific toxicity was increased frequency/urgency. CONCLUSIONS: AD32 is safe and active for treatment of recurrent or refractory superficial bladder carcinoma. The agent awaits more complete characterization when drug production problems can be solved.

Prostate cancer in men using testosterone supplementation.

PURPOSE: Although an association between testosterone supplementation and the development of prostate cancer is unproven, a recent increase in the use of this therapy has reopened the debate about its safety in men at risk for prostate cancer. To increase awareness of this risk, we report on a series of patients in whom clinically significant prostate cancer developed and was presumed to be related to exogenous testosterone use. MATERIALS AND METHODS: The medical records of 6 urology practices were reviewed to identify men undergoing testosterone supplementation for sexual dysfunction or "rejuvenation " who were found to have prostate cancer after initiation of exogenous testosterone supplementation. Cases were analyzed to determine clinical and pathological parameters characterizing the presentation of prostate cancer. RESULTS: A total of 20 men were diagnosed with prostate cancer after initiation of testosterone therapy. Prostate cancer was detected within 2 years of testosterone initiation in 11 men (55%) and from 28 months to 8 years in the remainder. The tumors were of moderate and high grade, being Gleason sum 6, 7 and 8 to 10 in 9 (45%), 6 (30%) and 5 (25%) men, respectively. Median serum prostate specific antigen (PSA) concentration at diagnosis tended to be low at 5.1 ng/ml (range 1.1 to 329.0) and digital rectal examination generally proved more sensitive than PSA assays in detecting the cancer. Patients seen by nonurologist physicians were monitored less often for prostate cancer during testosterone use than those followed by urologists. CONCLUSIONS: Prostate cancer may become clinically apparent within months to a few years after the initiation of testosterone treatment. Digital rectal examination is particularly important in the detection of these cancers. Physicians prescribing testosterone supplementation and patients receiving it should be cognizant of this risk, and serum PSA testing and digital rectal examination should be performed frequently during treatment.

2003 American Urological Association Gallup survey: physician practice patterns, cryosurgery/brachytherapy, male infertility, female urology and insurance/professional liability.

PURPOSE: The Health Policy Survey and Research Committee of the American Urological Association and the Gallup Organization have performed 10 surveys of American urologists since 1992 for the purpose of assessing demographics and practice patterns. The results of the 2003 survey are presented. MATERIALS AND METHODS: A random sample of 510 urologists who have completed urological residencies was interviewed by telephone in February 2003. Major content areas were physician practice patterns, cryosurgery/brachytherapy, male infertility, female urology and insurance/ professional liability. RESULTS: Urologists are older, staying in practice longer and planning to retire later than ever before. Urologists are also seeing more patients in the office every year. Most urologists treat male infertility and female voiding dysfunction. CONCLUSIONS: American urologists are older, working harder and planning on continuing to do so for longer than in any year sampled in the last decade.

2001 American Urological Association Gallup Survey: changes in physician practice patterns, satisfaction with urology, and treatment of prostate cancer and erectile dysfunction.

PURPOSE: The Health Policy Survey and Research Committee of the American Urological Association and the Gallup organization have performed 9 surveys of American urologists since 1992 for the purpose of assessing demographics and practice patterns. The results of the 2001 survey are presented. MATERIALS AND METHODS: A random sample of 507 urologists was interviewed in February and March 2001. Major content areas were physician practice patterns, cryosurgery/brachytherapy, prostate specific antigen, erectile dysfunction, Medicare and the Internet. RESULTS: Membership in the American Urological Association continues to increase among American urologists. The number of patients seen weekly in the office also continues to increase. While age at retirement has not changed significantly, most urologists are satisfied with the specialty and increasing numbers are using the Internet. CONCLUSIONS: Minimally invasive procedures such as brachytherapy for prostate cancer continue to proliferate and there is evidence that the specialty of urology is continuing to become more office based. The demand for urological services appears to be continuing to increase.