Orchiectomy and orchiectomy plus mitomycin C for metastatic prostate cancer in patients with poor prognosis: the final results of a European Organization for Research in Cancer Therapy Genitourinary Group Trial.

PURPOSE: The outcome of patients with symptomatic metastatic prostate cancer is poor and improved treatment regimens are urgently needed. Theoretically, the combination of orchiectomy and chemotherapy could reduce androgen sensitive and insensitive cells in the prostate. This European Organization for Research in Cancer Therapy Genitourinary Group randomized, multicenter phase III trial demonstrates the outcome of orchiectomy alone versus orchiectomy followed by intravenous mitomycin C. MATERIALS AND METHODS: A total of 189 patients with metastatic prostate cancer and poor prognostic factors were randomized in this trial by 42 institutions. Of these patients 184 (97%) were eligible for study, including 90 treated with orchiectomy alone (orchiectomy only arm) and 94 treated with orchiectomy followed by 15 mg./m.2 mitomycin C in 1 week (combined treatment arm). Mitomycin C was administered every 6 weeks and treatment was continued as long as tolerance and patient compliance allowed, and no progression was observed. Objective and subjective criteria for progression were clearly defined in the protocol. RESULTS: Patient and tumor characteristics were well balanced between the 2 treatment arms. At a median followup of 4.2 years 144 patients had died, including 112 of prostate cancer. No significant differences for time to overall (p = 0.17), subjective (p = 0.25) and objective (p = 0.08) progression were found between the 2 treatment groups. For progression-free survival no difference was noted (p = 0.67) between the 2 treatment groups but a trend in favor of orchiectomy alone was observed for overall survival (p = 0.04). Mitomycin C induced considerable hematological, gastrointestinal, renal and pulmonary toxicity leading to discontinuation in 31% of patients with pulmonary toxicity and 7% with renal deterioration. In addition, the quality of life evaluation revealed significant reduction in the combined treatment arm. CONCLUSIONS: Based on the results of this randomized phase III study orchiectomy plus mitomycin C for metastatic prostate cancer in patients with poor prognostic factors cannot be recommended due to failure of improvement in survival and reduced quality of life parameters.

Specificity and accuracy of TRUS-measured PSA-density and transition zone-PSA in the diagnosis of prostate cancer.

Between 4 and 15 ng/ml serum prostate-specific antigen (PSA) has a low specificity for prostate cancer (PCa). One accepted method to enhance this specificity is transrectal ultrasonography (TRUS)-measured PSA-density (PSA-D). We compared this method with a new alternative, transition zone PSA (PSA-TZ). We measured total and transition zone prostatic volumes by TRUS and calculated PSA-D and PSA-TZ in 59 patients with suspicion of PCa and PSA between 4 and 15 ng/ml. All patients then had sextant biopsies of the prostate, 30 were positive for PCa and 29 showed benign tissue. With a cut-off value of 0.35, PSA-TZ had a positive predicted value of 77% for PCa, whereas PSA-D, with a cut-off value of 0.12, had a positive predicted value of 55%. Our data suggest PSA-TZ to be more reliable for avoiding unnecessary biopsies in patients with PCa suspicion and serum PSA below 15 ng/ml. PSA-TZ, calculated by TRUS, enhances the specificity of PSA for needle biopsy diagnosis of PCa.

Electromyography of cavernous smooth muscle during flaccidity: evaluation of technique and normal values.

Objective evaluation of the penile innervation in impotent patients is mostly restricted to examination of the somatic pudendal pathways. These tests provide little information on the pelvic-cavernous autonomic innervation of the corporeal bodies. Electromyography of the flaccid penile smooth muscle is a reproducible and non-invasive method of evaluating these autonomic pathways and the status of intrinsic smooth muscle. Examination techniques and normal values have been studied in 15 young and potent volunteers. Recordings in 13 patients with neuropathology and 57 impotent patients are discussed.

Reproducibility of transrectal ultrasound of prostatic disease.

One hundred patients with suspicion of prostatic disease were examined by transrectal ultrasound. Two urologists with experience in this technique performed the examination separately for each patient. In the present study the differential diagnosis between normal prostate, benign hypertrophy and prostate cancer was almost perfectly reproducible. However, prostatitis was a difficult diagnosis by transrectal ultrasound. Prostatic cysts and stones were readily recognised. Although not perfectly reproducible, the transverse dimensions of the prostatic adenomas were reasonably comparable. Measurement of the longitudinal diameter of prostatic adenomas was difficult and poorly reproducible in our hands.

Endoscopic resection as treatment of enuresis with posterior urethral valves.

25 boys with both nocturnal enuresis and diurnal urgency, underwent a transurethral resection of a posterior urethral valve. Seventeen patients were cured, two improved partially, two did not respond and four were lost to follow-up. The authors recommend a routine voiding cysto-urethrogram in the work-up of enuretic boys, especially when nocturnal enuresis goes with diurnal urgency.