Robert P. Gibbons

Prostate Cancer Clinical Guidelines Panel Summary Report on the Management of Clinically Localized Prostate Cancer

PURPOSE The American Urological Association convened the Prostate Cancer Clinical Guidelines Panel to analyze the literature regarding available methods for treating locally confined prostate cancer, and to make practice policy recommendations based on the treatment outcomes data insofar as the data permit. MATERIALS AND METHODS The panel searched the MEDLINE data base for all articles from 1966 to 1993 on stage T2 (B) prostate cancer and systematically analyzed outcomes data for radical prostatectomy, radiation therapy and surveillance as treatment alternatives. Outcomes considered most important were survival at 5, 10 and 15 years, progression at 5, 10 and 15 years, and treatment complications. RESULTS The panel found the outcomes data inadequate for valid comparisons of treatments. Differences were too great among treatment series with regard to such significant characteristics as age, tumor grade and pelvic lymph node status. The panel elected to display, in tabular form and graphically, the ranges in outcomes data reported for each treatment alternative. CONCLUSIONS In making its recommendations, the panel presented treatment alternatives as options, identifying the advantages and disadvantages of each, and recommended as a standard that patients with newly diagnosed, clinically localized prostate cancer should be informed of all commonly accepted treatment options.

Adjuvant Radiotherapy Following Radical Prostatectomy: Results and Complications

Between 1954 and 1978, 148 patients underwent radical perineal prostatectomy for adenocarcinoma clinically confined to the prostate gland. This report is based on 45 of these patients with microscopic extension of disease beyond the gland and a minimum 5-year followup. Of the patients 22 received adjuvant external beam radiation therapy and 23 did not. The groups were comparable with regard to significant prognostic variables. Patient selection was by surgeon preference. Local recurrences were seen in 1 of 22 patients (5 per cent) receiving adjuvant radiotherapy and 7 of 23 (30 per cent) undergoing an operation alone (p less than 0.05). Of 8 patients with local recurrence 7 died of the disease. Delayed radiotherapy of a local recurrence generally was not effective in controlling the disease. Of the 11 patients who died of prostatic cancer with a mean followup of 9.2 years 3 received adjuvant radiotherapy and 8 did not. Severe but nonfatal long-term complications were seen in 14 per cent of the irradiated patients and 6 per cent of those treated with an operation alone. Most of the complications occurred in the earlier years of the study in patients who received 60cobalt radiotherapy. When clinical stage B cancer of the prostate is found to be pathological stage C following radical perineal prostatectomy, adjuvant radiotherapy can decrease the incidence of subsequent local recurrence. The potential risk of adjuvant radiation therapy should be weighed and its use considered, particularly in patients whose tumor extends to the surgical margins or who have seminal vesicle invasion.

Total Prostatectomy for Localized Prostatic Cancer

Several treatment options currently are available for the patient with clinically localized carcinoma of the prostate and each has its proponents. Comparison of results between institutions becomes necessary to determine the relative value of these treatments, keeping in mind the absence of a suitable control group in any series. Such inter-institutional treatment comparisons are possible only if the patient compositions are similar in terms of age, grade and extent of disease. Comparisons of patients with stage B disease frequently are made because most urologists agree that these patients have palpable disease confined to the prostate and no evidence of metastasis. At our clinic willing patients with clinically localized adenocarcinoma of the prostate who have an expected 15-year survival are treated preferentially with total prostatectomy. We summarize our experience with total prostatectomy in 215 consecutive patients, including 213 who were available for followup. There were 16 patients with clinical stage A, 195 with clinical stage B and 2 with clinical stage C disease. Of these patients 207 underwent radical perineal prostatectomy and there were no operative deaths. Patients did not receive adjuvant hormonal therapy unless disease recurred. Of the 110 patients who have undergone the operation within the last 5 years 98 per cent are alive. Actual survival and survival free of disease, respectively, for the entire series were 55 and 48 per cent at 15 years, 75 and 67 per cent at 10 years, and 94 and 86 per cent at 5 years, compared to 55 and 48, 74 and 67, and 95 and 90 per cent, respectively, for the 195 patients with clinical stage B disease. We believe these results demonstrate that in terms of local control of the disease, over-all survival and survival free of disease total prostatectomy remains the optimal treatment for patients with clinically localized carcinoma of the prostate.

Treatment of newly diagnosed metastatic prostate cancer patients with chemotherapy agents in combination with hormones versus hormones alone

A prospective trial from July 1976 to September 1980 by the National Prostatic Cancer Project randomized newly diagnosed metastatic prostate cancer patients to DES 1 mg orally three times daily or orchiectomy; or DES, 1 mg, three times daily, plus cyclophosphamide at 1 mg/m2 iv every three weeks, or cyclophosphamide 1 g/m2 iv every three weeks plus estramustine phosphate (Estracyt) at 600 mg/m2 orally daily in three divided doses. There were 246 patients evaluated for response of 301 entered. These consisted of 83 on the DES/orchiectomy arm, 77 on DES plus cyclophosphamide, and 86 on Estracyt plus cyclophosphamide. Objective response rates, initially evaluated at 12 weeks, were similar among the treatments. However, chemotherapy as used in this study early in the diagnosis of metastatic disease appears to exhibit an improved effect on overall survival compared to hormone therapy alone. Analysis within groups having pain versus no pain at entry revealed a marked advantage after 80 weeks for chemotherapy when pain was initially present and a slight advantage during treatment (throughout follow‐up) when the pain was absent. Median survival times were 92, 91, and 94 weeks, respectively, for the three treatments. The progression‐free interval for responders showed no difference between initial treatments, although nearly one half of the patients are still in remission; hence, further follow‐up will be essential. Side effects were not excessive for the chemotherapy treatment arms and patient compliance was good. This national multicenter trial provides the basis for further testing of chemotherapy agents at an earlier phase for patients with newly diagnosed metastatic prostate cancer.

Kidney Stone Removal: Percutaneous Versus Surgical Lithotomy

Percutaneous removal of most urinary tract calculi may be performed as a 1-stage effort with techniques and skills developed recently in the specialties of urology and radiology. Ultrasonic fragmentation of most calculi was done to permit their extraction. Percutaneous ultrasonic lithotripsy was performed on 250 consecutive (a single exception) patients bearing stones that required removal. Targeted calculi were removed successfully from 97 per cent of these patients. One patient required surgical lithotomy. The previous 100 patients with stones underwent surgical lithotomy with 96 per cent success. Complications of percutaneous ultrasonic lithotripsy appeared equitable with those of surgical lithotomy. Of the patients who underwent percutaneous ultrasonic lithotripsy 6 (6 per cent) required extended hospital days or additional procedures for management of complications. None of these patients required a surgical incision. Anesthesia times were similar for both groups--average 159 plus or minus 4 (standard error) minutes for percutaneous ultrasonic lithotripsy and 193 plus or minus 8 minutes for surgical lithotomy. Hospital recovery days averaged 5.5 plus or minus 0.3 for percutaneous ultrasonic lithotripsy and 8.4 plus or minus 0.5 for surgical lithotomy (p less than 0.01). Associated costs averaged

Chemotherapy of advanced prostatic cancer Evaluation of response parameters

7,203 plus or minus 55 for lithotripsy and

Total Prostatectomy for Clinically Localized Prostatic Cancer: Long-term Results

8,849 plus or minus 660 for lithotomy (p less than 0.01). The number of narcotic administrations per patient (days 1 to 5 postoperatively) averaged 9.88 plus or minus 0.70 for lithotripsy and 16.82 plus or minus 0.78 for lithotomy (p less than 0.01). The average patient who underwent percutaneous ultrasonic lithotripsy felt capable of full activity 2.0 plus or minus 0.2 weeks following stone removal, whereas no patient who underwent previous surgical lithotomy recalls a recovery period of less than 3 weeks (p less than 0.01). We believe that most upper urinary tract calculi may be removed cost-effectively with a percutaneous approach. Compared to surgical lithotomy, percutaneous ultrasonic lithotripsy may result in rapid convalescence with diminished pain.

Experience with Indwelling Ureteral Stent Catheters

A total of 125 patients with progressing advanced prostatic cancer were entered into a chemotherapy study comparing cyclophosphamide, 5-fluorouracil, and standard therapy. Parameters of response were studied in 110 patients who could be evaluated. Thirty-six patients (33 per cent) were considered to have an objective response, that is becoming stable (29 patients) or in partial regression (7 patients). Negative response parameters (predictors of a poor response to chemotherapy or standard theraphy leading to progress) included (1) bone marrow evidence of prostatic cancer, (2) abnormal liver scan, (3) prior radiation therapy (indirectly through increased toxicity to chemotherapy), and (4) lack of bilateral orchiectomy prior to randomization. Positive indicators (predictors of good responses) included (1) reduction of primary tumor mass, especially after administration of 5-fluorouracil or cyclophosphamide, and (2) hemoglobin values. There were more objective responders to cyclophosphamide than standard therapy whether the hemoglobin was initially normal or low. Indeterminate parameters of response included weight gain, presence of bony or soft tissue metastases, relief of pain, performance status, excretory urography, and biochemical determinations of liver and renal function.

Needle tract seeding following aspiration of renal cell carcinoma.

The fate of the first 52 patients with clinically localized prostate cancer who underwent total perineal prostatectomy at our clinic and have been followed for a minimum of 15 years is reviewed to evaluate the long-term impact of this operation on the disease. None of these patients received any adjuvant therapy. Nine patients (17 per cent) had recurrence and 5 (10 per cent) died of disease during this interval. The actual observed over-all survival at 15 years was 64 per cent, the actuarial survival was 67 per cent and the cause-specific survival was 90 per cent.

Clinical outcomes in patients who undergo extracorporeal shock wave lithotripsy for chronic calcific pancreatitis.

A new indwelling ureteral stent to provide long-term ureteral drainage is described. This radiopaque stent is manufactured of non-reactive, non-collapsible tubing and is designed to resist downward expulsion and upward migration. Internal stent diversion offers advantages in managing patients whose ureters are obstructed by malignancy. 1) Endoscopic placement of the ureteral stent is associated with less morbidity and mortality than supravesical diversion. 2) Unilateral obstruction can be corrected at the time of diagnosis, thus ensuring that later supravesical diversion will not be necessary. 3) If time proves that the urinary diversion is no longer desirable in terms of quality of life, the stent can be removed.