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Objective: To review the pioneering contributions of Dr. Robert Gibbons of Virginia Mason Medical Center to the evolution and development of the modern ureteral stent., Methods: We reviewed Dr. Gibbons' extensive work through primary sources, including interviews, projector slides, radiology images, stent prototypes, his personal writings, and archived documents. In addition, we performed a review of historical texts and manuscripts describing important innovations in the development of the ureteral stent., Results: In 1972, motivated by a desire to provide his patients with a long-term alternative to open nephrostomy and inspired by Drs. David Davis and Paul Zimskind, who in 1967 had described the use of indwelling ureteral silicone tubing, Dr. Gibbons began to experiment with modifications to improve upon existing stents. To address distal migration, Dr. Gibbons added "wings" that collapsed as the stent was advanced and expanded once in proper position to secure the stent in place. Barium was embedded into the proximal tip to facilitate radiographic visualization. A flange was added to the distal end, preventing proximal migration and minimizing trigonal irritation, and a tail was attached to aid in stent removal. The result was the original Gibbons stent, the first commercially available ureteral stent, and the establishment of Current Procedural Terminology code 52332, still used today., Conclusion: The ureteral stent is a fundamental component of urologic practice. In developing the Gibbons stent, Dr. Gibbons played a pivotal role in addressing the challenge of internal urinary diversion particularly for those who needed long-term management. Urologists and the patients they serve owe Dr. Gibbons and other surgeon-inventors a debt of gratitude for their innovative work., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: We describe a model capable of predicting prostate cancer (PCa)-specific mortality up to 20 years after a radical prostatectomy (RP), which can adjust the predictions according to disease-free interval., Patients and Methods: 752 patients were treated with RP for organ-confined PCa. Cox regression modeled the probability of PCa-specific mortality. The significance of the predictors was confirmed in competing risks analyses, which account for other-cause mortality., Results: The mean follow-up was 11.4 years. The 5-, 10-, 15- and 20-year actuarial rates of PCa-specific survival were 99.0, 95.5, 90.9 and 85.7%, respectively. RP Gleason sum (p < 0.001), pT stage (p = 0.007), adjuvant radiotherapy (p = 0.03) and age at RP (p = 0.004) represented independent predictors of PCa-specific mortality in the Cox regression model as well as in competing risks regression. Those variables, along with lymph node dissection status (p = 0.4), constituted the nomogram predictors. After 200 bootstrap resamples, the nomogram achieved 82.6, 83.8, 75.0 and 76.3% accuracy in predicting PCa-specific mortality at 5, 10, 15 and 20 years post-RP, respectively., Conclusions: At 20 years, roughly 20% of men treated with RP may succumb to PCa. The current nomogram helps to identify these individuals. Their follow-up or secondary therapies may be adjusted according to nomogram predictions., (Copyright (c) 2010 S. Karger AG, Basel.)

Objective: To assess the effect of adjuvant radiotherapy (aRT) on the rate of cancer-specific and overall survival after radical prostatectomy (RP) in a group of patients with a long-term follow-up, as there is controversy about the benefit of aRT after RP for prostate cancer when endpoints beyond biochemical and local recurrence are considered., Patients and Methods: Within a study cohort of 752 patients treated with RP, 118 (15.7%) received aRT; these patients were matched with controls who did not receive aRT after RP. Exact matches were made for pT stage, RP Gleason sum, surgical margin status, age (+/-10 years), year of surgery (+/-10 years) and delivery of hormonal therapy. Kaplan-Meier and life-table analyses were used to assess overall and cancer-specific survival, Results: The median (range) follow-up was 11.4 (0.1-41) years. The 10- and 20-year overall survival after RP in those with no aRT were, respectively, 81.1% and 44.8%, vs 75.5% and 40.0% in the aRT group (P = 0.1). The corresponding probabilities for cause-specific survival were, respectively, 97.3% and 89.0% vs 86.3% and 69.3% (P < 0.001). There was no statistically significant difference in the overall and cause-specific survival between the groups after matching (hazard ratio 0.9, log rank P = 0.6; and 2.1, log rank P = 0.1, respectively)., Conclusions: Our analysis showed that, in a matched case-control study, aRT has no effect on overall and cancer-specific survival. Further randomized long-term studies are necessary to confirm these results.

Objectives: To develop and internally validate a nomogram predicting the individual probability of metastatic progression after radical prostatectomy according to the length of disease-free interval., Methods: Cox regression modeled the probability of metastatic progression of prostate cancer in 752 patients treated with radical prostatectomy with a mean follow up of 11.6 years (median 11.4; range 0.1-40.5). The significance of the predictors was confirmed in competing risks analysis, which accounts for other causes of mortality. The Cox regression model-based nomogram was internally validated with 200 bootstrap resamples., Results: Eighty-five of 752 patients (11.3%) developed metastatic progression. The 5, 10, 15 and 20-year actuarial rates of metastatic progression-free survival were, respectively, 95.9, 90.5, 84.8 and 80.5%. Pathological stage T3, elevated radical prostatectomy Gleason sum and delivery of adjuvant radiotherapy represented independent predictors of metastatic progression in both Cox and competing risks regression models, and constituted the nomogram predictors along with a fourth variable describing the presence of co-morbidities. After 200 bootstrap resamples the nomogram achieved 80.2, 77.7, 77.6 and 76.0% accuracy in predicting metastatic progression at 5, 10, 15 and 20 years after radical prostatectomy., Conclusions: Metastatic progression is a sign of poor prognosis in men with prostate cancer. Our nomogram is able to accurately predict the conditional probability of metastatic progression up to 20 years after radical prostatectomy.

Background: Men who undergo radical prostatectomy (RP) are at long-term risk of biochemical recurrence (BCR). In this report, the authors have described a model capable of predicting BCR up to at least 15 years after RP that can adjust predictions according to the disease-free interval., Methods: Cox regression was used to model the probability of BCR (a prostate-specific antigen level>0.1 ng/mL and rising) in 601 men who underwent RP with a median follow-up of 11.4 years. The statistical significance of nomogram predictors was confirmed with a competing-risks regression model. The model was validated internally with 200 bootstraps and externally at 5 years, 10 years, and 15 years in 2 independent cohorts of 2963 and 3178 contemporary RP patients from 2 institutions., Results: The 5-year, 10-year, 15-year, and 20-year actuarial rates of BCR-free survival were 84.8%, 71.2%, 61.1%, and 58.6%, respectively. Pathologic stage, surgical margin status, pathologic Gleason sum, type of RP, and adjuvant radiotherapy represented independent predictors of BCR in both Cox and competing-risks regression models and constituted the nomogram predictor variables. In internal validation, the nomogram accuracy was 79.3%, 77.2%, 79.7%, and 80.6% at 5 years, 10 years, 15 years, and 20 years, respectively, after RP. In external validation, the nomogram was 77.4% accurate at 5 years in the first cohort and 77.9%, 79.4%, and 86.3% accurate at 5 years, 10 years, and 15 years, respectively, in the second cohort., Conclusions: Patients who undergo RP remain at risk of BCR beyond 10 years after RP. The nomogram described in this report distinguishes itself from other tools by its ability to accurately predict the conditional probability of BCR up to at least 15 years after surgery., (Copyright (c) 2008 American Cancer Society.)

Objectives: We hypothesized that prostate cancer-specific survival (PCaSS) could be accurately predicted in men in whom radical prostatectomy (RP) failed and who received hormonal therapy (HT) after RP failure., Methods: Between 1954 and 1994, 752 consecutive patients underwent RP without neoadjuvant therapy. Of those, 114 patients (15.2%) received HT at RP failure and represent the focus of this analysis. Cox regression models and a nomogram targeted PCaSS. The main predictor was timing of HT initiation: at prostate-specific antigen (PSA) versus local versus distant recurrence. Covariates included age at HT, pathologic T stage, surgical margin status and Gleason sum at RP, use of adjuvant or salvage radiation, and time from RP to HT., Results: Mean and median follow-up periods were 5.1 and 3.9 yr; 70 deaths were recorded, of which 45 (39.8%) were due to PCa. At 1, 5, 10, and 15 yr, the estimates of PCaSS were, respectively, 97.1%, 68.3%, 49.3%, and 30.2% (median, 9.8 yr). Younger men and those with HT initiated at the time of distant recurrence had lower PCaSS. A nomogram predicting PCaSS at 2, 3, 4, and 5 yr after RP was developed and demonstrated 66% accuracy after 200-bootstrap internal validation., Conclusion: Despite RP failure, half the patients can expect to survive for 10 yr. The nomogram can help in discriminating between those with better versus worse PCaSS, better than relying on most educated guesses.

Purpose: We report on 25-year cancer control and survival outcomes after radical prostatectomy in a single center series of patients treated during a 40-year period., Materials and Methods: Between 1954 and 1994, 787 consecutive patients underwent radical prostatectomy at Virginia Mason Medical Center in Seattle, Washington. Kaplan-Meier 25-year probabilities of prostate cancer specific, overall, prostate specific antigen progression-free, local and distant progression-free survival were determined. Multivariate Cox regression models addressed prostate cancer specific mortality., Results: Prostate cancer specific survival, overall survival, prostate specific antigen progression-free survival, local and distant progression-free survival ranged from 99.0% to 81.5%, 93.5% to 19.3%, 84.8% to 54.5%, 95.3% to 87.8% and 95.9% to 78.2%, respectively. In univariate analyses pathological stage, surgical margin status, pathological Gleason sum, delivery of hormonal therapy and radiotherapy represented statistically significant predictors of prostate cancer specific mortality (all p < or =0.001). In multivariate analyses only Gleason sum (p = 0.03) and delivery of hormonal therapy (p < 0.001) remained significant., Conclusions: This is one of the most mature radical prostatectomy series. It demonstrates that long-term biochemical cancer control outcomes after radical prostatectomy might be suboptimal. However, local and distant control outcomes are excellent, and cancer specific mortality is minimal even 25 years after surgery.

Background: There is controversy as to whether extracorporeal shock wave lithotripsy fragmentation and ERCP retrieval of pancreatic stones are associated with relief of chronic pain or relapsing attacks of pancreatitis. Our most recent experience with this technology is reviewed., Methods: Forty patients with chronic calcific pancreatitis who required extracorporeal shock wave lithotripsy between 1995 and 2000 to facilitate pancreatic duct stone removal were retrospectively reviewed. Data collected included patient presentation, number of lithotripsy and ERCP sessions required, complications, and outcomes measures to include pre- and post-ESWL pain scale, monthly oxycodone (5 mg)-equivalent pills ingested, yearly hospitalizations, and need for subsequent surgery., Results: A single extracorporeal shock wave lithotripsy session was required for 35 patients who underwent a total of 86 ERCPs to achieve complete stone extraction from the main pancreatic duct. Minor complications occurred in 20%. There was one episode of pancreatic sepsis that was treated with antibiotics and removal of an occluded pancreatic prosthesis. At a mean [SD] follow-up of 2.4 (0.6) years, 80% of patients had avoided surgery and there was a statistically significant decrease in pain scores (6.9 [1.3] vs. 2.9 [1.1]; p = 0.001), yearly hospitalizations for pancreatitis (3.9 [1.9] vs. 0.9 [0.9]; p = 0.001), and oxycodone-equivalent narcotic medication ingested monthly (125 [83] vs. 81 [80]; p = 0.03)., Conclusions: Extracorporeal shock wave lithotripsy fragmentation of pancreatic duct calculi in conjunction with endoscopic clearance of the main pancreatic duct is associated with significant improvement in clinical outcomes in most patients with chronic pancreatitis.

Objectives: The modern three-piece inflatable penile prosthesis (IPP) has undergone multiple revisions since its introduction in 1973. We reviewed devices placed since the last major revision by American Medical Systems (AMS) in 1987., Methods: A retrospective chart review was refined with data from an independent patient and partner survey., Results: Two hundred twelve consecutive penile prosthetic devices placed by a single surgeon over an 8-year period are reviewed. One hundred sixty-nine of the devices were three-piece inflatables with 146 being primary implants. The average device has been in place 36.5 months (range 9 to 102). The infection rate in 146 primary three-piece devices was 2.1%. The infection rate in 46 secondary implants or revisions was 6.5%, excluding seven salvage attempts. Mechanical failure in 122 primary AMS devices placed was 4.1%. Mechanical failure in 24 Mentor devices was 4.2% if one discounts connector failures that were revised in 1990. A surgical complication and revision rate of 1.4% was noted in the 146 primary implants. An independent telephone survey achieved a 57% and 24% response rate in patients and partners with three-piece devices placed. In the group of 86 patients with a primary three-piece device placed and complete follow-up, the probability of having a normally functioning device placed in a single operative procedure was 90.6% at 3 years. On a 1 to 10 scale looking at all primary devices, secondary devices, revisions, and infections, the average and median satisfaction rate was as follows: 8.2, 8.5; 8.4, 9.0; 7.7, 7.75 for the Ultrex patients, CX 700 and Mentor patients, and all partners, respectively., Conclusions: The modern three-piece IPP is an excellent surgical option offering a very safe, reliable return to sexual activity for our patients.

Background: Bile duct calculi (BDC) can be cleared or treated with modern endoscopic techniques in most patients. However, large stones, bile duct strictures, or unusual anatomy may make endoscopic clearance difficult. The purpose of the present study was to determine the efficacy of extracorporeal shock-wave lithotripsy (ESWL) in treating patients with complicated BDC., Methods: Between 1989 and January 1995, 16 patients with BDC were treated at our institution with ESWL using a Dornier HM-3 lithotropter. The average age of patients was 62 years (range 32 to 88). Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and attempted stone extraction (100%), nasobiliary drainage (83%), and biliary stents (6%) were used prior to ESWL. Eleven patients (61 %) had solitary stones, ranging in diameter from 0.5 to 2.6 cm, whereas 7 patients had multiple stones, ranging in diameter from 0.5 to 5.0 cm. The indications for ESWL were stone impaction (56%), stone size (38%), and bile duct stricture (6%)., Results: The 16 patients received 27 ESWL treatments (mean = 2101 shock at 21 kV); with 4 patients (22%) requiring multiple treatments. Stone fragmentation was achieved in 94% of patients. All patients had ERCP performed post-ESWL, and only 2 (13%) patients required immediate operations. At discharge, 94% of patients were stone-free. Minor complications (eg, pain, hematuria) were common. With an average follow-up of 3 years, only 1 patient (6%) has required retreatment for BDC. Hepatic transplantation was required in an additional patient., Conclusions: In this cohort of patients with both major medical comorbidities and/or technical contraindications to standard methods of endoscopic and surgical clearance of BDC, we found that ESWL facilitated stone clearance in 94% of patients with minimal morbidity and no mortality. In our opinion, ESWL should be used more frequently in the treatment of these complex patients.

Purpose: A review was done to determine the effectiveness of extracorporeal shock wave lithotripsy (ESWL) in the treatment of impacted pancreatic duct calculi., Materials and Methods: A total of 19 patients, who were potential candidates for radical pancreatic surgery after unsuccessful endoscopic retrograde cholangiopancreatography, sphincterotomy and attempted stone extraction from the pancreatic ducts, underwent ESWL of the calculi. Followup ranged from 6 months to 6 years., Results: Of the 19 patients 14 avoided a major operation and 6 have remained pain-free for the long term. Two patients died of causes not related to ESWL or endoscopic retrograde cholangiopancreatography. Five patients eventually underwent a Whipple or Puestow procedure for relief of symptoms or persistent obstruction. Complications were minimal., Conclusions: ESWL is a valuable adjunct in patients with impacted pancreatic duct calculi unretrievable by primary endoscopic retrograde cholangiopancreatography.

Purpose: Various materials and techniques have been used to construct a pubovaginal sling. We believe that fascia lata has several advantages and report our experience., Materials and Methods: A total of 32 female patients with urodynamically proved intrinsic sphincter deficiency underwent a pubovaginal sling procedure using fascia lata. An unscarred fascial strip 24 to 28 x 2 cm. was attached to itself over a 3 to 4 cm. bridge of abdominal wall fascia. Results were tabulated by chart review and an independent patient survey., Results: Chart review revealed that 28 of 32 patients (87%) required no pads, and 3 improved and 1 did not. An independent patient survey revealed that 70% of patients (21 of 30) required no pads, 20% required 1 to 3 small pads and 10% required more than 3 small pads per day. Of the patients 80% would undergo the procedure again., Conclusions: Excellent results can be obtained with fascia lata for the treatment of intrinsic sphincter deficiency. A long, wide strip of fascia attached to itself allows for precise tensioning and good urethral closure, and minimizes the risk of obstruction.

Objective: Because of efficacy demonstrated with chemotherapy in patients with metastatic disease, the National Prostate Cancer Project in 1978 initiated two protocols evaluating adjuvant therapy following surgery (Protocol 900) and irradiation (Protocol 1000) for patients with localized disease at high risk for relapse., Methods: All patients underwent staging pelvic lymph node dissection. Following definitive treatment, patients were randomized to either cyclophosphamide 1 g/m2 intravenously every 3 weeks for 2 years, estramustine phosphate 600 mg/m2 orally daily for 2 years or to observation only. Accession closed in 1985 and included 184 patients in Protocol 900 (170 evaluable) and 253 in Protocol 1000 (233 evaluable)., Results: Nodal involvement was identified in 198 patients (49% of total): 29% in Protocol 900 and 63% in protocol 1000. Median progression-free survival (PFS) and survival have been greater for patients in Protocol 900 regardless of adjuvant, reflecting their lower pathologic stage. Median PFS is significantly greater for patients in Protocol 1000 receiving estramustine (52.2 months) compared to cyclophosphamide (35.0 months). Median PFS for patients with nodal involvement in Protocol 1000 receiving estramustine is increased (43.5 months) compared to no treatment (21.5 months). Patients with limited nodal involvement in Protocol 1000 have a longer median PFS (45.6 months) compared to patients with extensive disease (23.6 months). But in the latter group patients receiving estramustine experienced a significantly longer median PFS (43.5 months) compared to cyclophosphamide (29.1 months) or no adjuvant (13.5 months). Increased PFS with estramustine adjuvant was also noted in stage C patients (only Protocol 900) and in those with high-grade (grade 3) tumors (both protocols)., Conclusions: With now over 10 years mean follow-up for this series of patients, we conclude that adjuvant estramustine is beneficial for prostate cancer patients receiving definitive irradiation. This benefit is particularly noted in those patients with extensive nodal involvement (N+, D-1).

In 1978 the National Prostate Cancer Project launched two protocols evaluating adjuvant therapy following surgery (Protocol 900) or irradiation (Protocol 1,000) for clinically localized prostate cancer. All patients underwent staging pelvic lymphadenectomy. Following definitive treatment, patients were randomized to either cyclophosphamide 1 gram/m2-IV every 3 weeks for 2 years, estramustine phosphate 600 mg/m2-po daily for up to 2 years, or to observation only. Patient accession closed in 1985 and includes 184 to Protocol 900 (170 evaluable) and 253 to Protocol 1,000 (233 evaluable). Lymph node involvement was identified in 198 patients (49% of total), 29% in Protocol 900, 63% in Protocol 1,000. Median progression-free survival (PFS) for patients with nodal involvement in Protocol 1,000 receiving estramustine phosphate adjuvant was longer (37.3 mo) compared to cyclophosphamide (30.9 mo) and to no treatment (20.9 mo). Median PFS for patients with limited nodal disease in Protocol 1,000 was longer (39.9 mo), regardless of adjuvant, compared to extensive nodal disease (20.7 mo). However for patients with extensive nodal involvement, those receiving adjuvant estramustine phosphate experienced a significantly longer median PFS (32.8 mo) compared to adjuvant cyclophosphamide (22.7 mo) and no adjuvant (12.9 mo). We conclude that adjuvant estramustine phosphate is of benefit in prostate cancer patients with extensive pelvic node involvement receiving irradiation as definitive treatment.

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.

A group of 170 impotent men achieved usable erections during a 26-month period with a combination of papaverine, phentolamine and prostaglandin E1 (triple-drug therapy) injected intracorporeally. Of the patients 146 elected to enter a pharmacological erection program using this combination. Patient age ranged from 24 to 85 years and the average duration on the program was 11.2 months. Average injection volume was 0.36 cc per injection (range 0.1 to 1). Among those patients managed by our nurse clinician, only 3 episodes of priapism were encountered (1.7%). Scarring was documented in 7 of 170 patients (4.2%) 1 week to 21 months after starting the injections. Pain was encountered in 6 of 170 patients (3.5%). A superior dose response coupled with a low incidence of priapism, pain and scarring have led us to use triple-drug therapy as our agent of choice in the pharmacological management of erectile dysfunction.

Total prostatectomy in the properly selected patient will provide disease-free survival rates comparable to the expected survival in similarly aged men for up to 30 years of observation (Figure 4). Patients who undergo total prostatectomy accept a very small risk of long-term permanent complications or mortality, and effective treatment is available for most complications. The morbidity and costs associated with hormone refractory metastatic prostate cancer are significant, with bone pain and anemia from bone marrow invasion, bladder dysfunction (retention, incontinence, and hematuria), urinary tract infection, anorexia, and uremia from obstructed ureters being common sequelae in the months before death. In the properly selected patient, minimal risk is incurred from total prostatectomy, the potential complications are well defined and manageable, and long-term disease-free survival is seen in most patients.

From May 1988 through May 1991, 14 patients with radiation-induced hemorrhagic cystitis confirmed by cystoscopy and biopsy, who had failed all other attempts at management and who had no evidence of infection or recurrent malignancy, were treated with hyperbaric oxygen therapy. During followup ranging from 10 to 42 months 8 patients (57%) had complete resolution of symptoms and 2 (14%) had marked improvement, for a total of 10 patients (71%) with a positive outcome. Of 4 patients (29%) with a poor outcome 3 had limited improvement and were later diagnosed as having recurrent malignancy that was not present on biopsy before hyperbaric treatment. One patient was withdrawn from hyperbaric treatment due to illness. The average cost per patient was $10,000 to $15,000, comparing favorably to the cost of multiple conservative treatments to control symptoms. Hyperbaric oxygen therapy for radiation-induced hemorrhagic cystitis appears to be an efficacious treatment modality for patients who have failed other forms of management.

Background: In 1978, the National Prostatic Cancer Project launched two protocols evaluating adjuvant therapy after surgery (Protocol 900) or irradiation (Protocol 1000) for clinically localized prostate cancer. All patients underwent staging pelvic lymphadenectomy., Methods: After definitive treatment, the patients were randomized either to receive cyclophosphamide 1 g/m2 intravenously every 3 weeks for 2 years or estramustine phosphate 600 mg/m2 orally daily for up to 2 years or to undergo observation only. Patient accession closed in 1985 and includes 184 patients in Protocol 900 (170 evaluable) and 253 in Protocol 1000 (233 evaluable)., Results: Lymph node involvement was identified in 198 patients (49% of total), 29% in Protocol 900 and 63% in Protocol 1000. The median progression-free survival (PFS) and survival were greater for patients in Protocol 900 compared with 1000, regardless of the adjuvant therapy. This reflected the greater proportion of patients with lower pathologic stage disease in the surgically treated group. The median PFS was significantly greater for all patients in Protocol 1000 receiving estramustine phosphate adjuvant (48.2 months) compared with patients randomized to receive cyclophosphamide (35.6 months). The median PFS for patients with nodal involvement in Protocol 1000 who received estramustine phosphate adjuvant was prolonged significantly (37.3 months) compared with no treatment (20.9 months). The median PFS for patients with limited nodal disease in Protocol 1000 was longer (39.9 months), regardless of the adjuvant therapy, compared with those with extensive nodal disease (20.7 months). However, in the latter patient group, those receiving adjuvant estramustine phosphate had a significantly longer median PFS (32.8 months) compared with those receiving adjuvant cyclophosphamide (22.7 months) or no adjuvant therapy (12.9 months)., Conclusion: Adjuvant estramustine phosphate was beneficial in patients with prostate cancer and pelvic node involvement who received irradiation as definitive treatment.

Many groups have taken the position that the digital rectal examination should be discontinued as part of the annual screening physical examination. We examined the effects of not doing a digital rectal examination on the early diagnosis of prostate cancer. The average time since a previous rectal examination increased as the stage of cancer increased. The digital rectal examination proved to be a relatively insensitive test, with 40% of stage D cancers being detected initially within 12 months of the most recent examination. Nevertheless, an annual digital rectal examination did detect a greater percentage of lower stage (and thus more localized and potentially curable) cancers when repeated within 12 months. When the last rectal examination was more than 24 months previous, cancers detected were more likely to be advanced. Without a digital rectal examination, patients would have their disease detected only by the presence of symptoms. When it was done because of symptoms, 81% of our patients had stage D cancers compared with 32% of stage B and 38% of stage C patients. Without the routine use of this examination, patients with prostate cancer would be more likely to have higher stage and less potentially curable lesions at the time of diagnosis. We conclude that the digital rectal examination remains an important part of routine annual physical examinations.

During the preceding 2 1/2 years 50 patients have undergone laser fragmentation of ureteral calculi at our medical center. Of these 50 patients 48 (96%) became free of stones without the need for an open operation: 44 (88%) were managed in 1 setting and 4 required adjunctive extracorporeal shock wave or ultrasonic lithotripsy, or a repeat session with the laser. Two patients (4%) eventually required an open operation: 1 required ureterolithotomy for a large impacted stone overlying the bony pelvis after a ureteroscope could not be advanced to this level and 1 had a good initial result with the laser but a persistent ureteral stricture developed and he required ureteroureterostomy 4 months later. Both open procedures were necessitated by mid ureteral stones, and the ureteral stricture was believed to be related to ureteroscopy and the impacted nature of the stone, rather than any damage by the laser probe.

Radical prostatectomy in patients who have had prior transurethral resection of the prostate has been reported to result in significant morbidity. From 1974 to 1982, 30 patients who had had previous transurethral resection of the prostate underwent radical perineal prostatectomy for localized prostatic cancer. Operative time and blood loss were similar to a group of patients who had not had prior transurethral resection of the prostate. Over-all, 3 patients (10 per cent) had total incontinence and 3 (10 per cent) had stress incontinence requiring a pad or device. No patient undergoing radical prostatectomy less than 4 weeks or more than 4 months after transurethral resection of the prostate had postoperative incontinence. When radical perineal prostatectomy was performed between 4 weeks and 4 months after transurethral resection of the prostate the incidence of incontinence was 50 per cent. Five patients experienced prolonged perineal urinary drainage, all but 1 of whom healed spontaneously. Of the 6 patients with incontinence 3 had prolonged drainage. No patient had a rectal injury and there was no operative mortality. Two patients died without cancer and 1 has evidence of disease recurrence. We conclude that radical prostatectomy may be performed safely with acceptable morbidity following transurethral resection of the prostate and that if 4 weeks has elapsed since resection it might be advantageous to wait 4 months before performing radical surgery to lessen the risk of incontinence.

A study was made of 35 patients with tumors of the renal pelvis. Tumors were indipendently graded and staged by a newly proposed method. The method of staging correlated well with grading of renal pelvic tumors and bore a direct relationship with prognosis. The high incidence of associated urothelial tumors, especially on the involved side, mandated radical nephroureterectomy including a bladder cuff as the treatment of choice.

The outcome for the first 57 successive patients who underwent total perineal prostatectomy for clinically localized prostate cancer at the Virginia Mason Clinic and who have been followed up for a minimum of 15 years is reviewed for evaluation of the long-term impact of this operation on the disease. Twenty percent of the patients had pathologic stage C disease. Recurrence developed in 11 of the 55 patients (20%) who could be evaluated, and death from prostate cancer occurred in 6 (11%) during this interval. The actual observed overall survival at 15 years or more was 60%, the actuarial survival 67%, and the cause-specific survival 89%. The current morbidity of this operation was evaluated by review of the last 50 consecutive patients who underwent this procedure and had follow-up of at least 6 months. Operative time averaged 140 minutes, and blood loss averaged 660 ml; 22% of the patients required a transfusion. Average postoperative hospitalization was 5 days. Two patients required a temporary colostomy for unrecognized rectal injury, and 2 developed a stricture requiring more than one dilation. Three patients (6%) wear pads for mild stress incontinence. One patient died of a cerebral vascular accident.

Estramustine has been shown previously to be an effective drug in the treatment of metastatic prostatic cancer, demonstrating significant objective and subjective responses in long-term non-randomized trials and in other randomized trials. In this study prednimustine alone has shown a minimal over-all objective response rate of 12.9% of the cases, although with marked subjective improvement of pain relief and patient performance status. The combination of prednimustine with estramustine did not result in improvement of objective or subjective response parameters. The effects in terms of responses or in terms of toxicity for either agent were not additive when they were given in combination. Cross-over for those patients whose disease progressed on prednimustine therapy to estramustine had some benefit in over-all survival. Prednimustine alone or in combination with estramustine may be used safely and could improve markedly the quality of life for irradiated patients with advanced prostatic cancer who failed on hormonal treatment and have too poor a bone marrow reserve to be treated by other currently available myelosuppressive agents.

We herein present the results of our first 100 kidney transplants. The 1-year patient and graft survivals were 94 and 74 per cent, respectively, for living related grafts, and 85 and 57 per cent, respectively, for cadaver grafts. These results compare favorably to the recent standards set by the American Society of Transplant Surgeons Standards Committee (95.1, 78.6, 88.6 and 55 per cent). Initial hospitalization averaged 21 plus or minus 7 days, while hospitalization during the first year after transplantation averaged 35 plus or minus 21 days. Average expenses (Medicare reimbursed) during the first 12 months after kidney placement were $29,572 plus or minus $6,468 for 15 successive patients. A total of 22 complications occurred within 1 year of transplantation and 11 required surgical management. Of 24 patients who survived 1 year with loss of graft function 15 (62 per cent) required transplant nephrectomy. Causes of death and types of complications are presented. Our results suggest that high quality kidney transplantation may be available to patients in small transplant centers.

In the 36 months since its inception, the National Prostatic Cancer Project treatment subgroup has randomly assigned over 360 patients with progressive advanced prostatic cancer who were no longer responsive to endocrine manipulation to either one of four different clinical studies. The initial study demonstrated a clear superiority for 5-fluorouracil (5-FU) and cyclophosphamide over continued conventional therapy. Beneficial responses were documented and are associated with increased survival rates and relief from pain and other symptoms. A proportionately larger number of patients obtained clinical benefit (stable and partial regression) on cyclophosphamide than on standard or 5-FU therapy. The criteria for evaluation of patients are supported by the survival data, ie, responders have survived for a longer period of time than those patients who continued in progression. Preliminary data from the subsequent protocols have documented a 30% response (stable and partial regression) in patients receiving oral estramustine phosphate and definite responses in patients treated with DTIC; Too few patients have been treated with Leo 1031 to offer total response rates at this time, although the early results are promising. These clinical studies have firmly established a place for chemotherapy in the management of prostatic cancer. New trials will introduce single- and multiple-drug chemotherapy at earlier phases of the clinical course of prostatic cancer patients.

Patients with renal cell carcinoma often have no specific localizing symptoms or signs, and their presentation will often involve many organ systems. Since 40 per cent of these patients do not have genitourinary symptoms, care must be taken to avoid being misled by normal findings on urinalysis. More than 50 per cent of patients with renal cell carcinoma have vague symptoms suggesting a gastrointestinal origin; thus if primary gastrointestinal studies do not disclose a cause for these symptoms, excretory urography must be included as a screening procedure.

The response and duration of survival were evaluated for patients with stage D relapsing prostatic cancer who were randomized to cyclophosphamide (cytoxan), 5-fluorouracil (5-FU) or standard therapy, or to subsequent chemotherapies. The chemotherapies on initial randomization were superior to the standard therapy in the number of responders and duration of response. Survival was longer for responders (stable or partial regression) on chemotherapy by comparison to responders (stable only) on standard therapy. The survival for patients receiving initial and crossover chemotherapy was significantly improved for patients who responded to therapy. Chemotherapy of advanced relapsing stage D prostatic cancer is more beneficially treated by specific chemotherapy as shown in this randomized study.

We report 10 cases of renal tumors in a solitary kidney that were treated surgically with efforts to spare renal function. Three patients were rendered anephric to excise completely the renal cancer and 2 remain without disease. The remaining 7 patients had complete tumor excision with the aid of partial nephrectomy. One patient had bilateral oncocytomas. Of the 6 partial nephrectomy patients with cancer 1 (18 per cent) remains free of metastatic disease. Concern is expressed for the role of partial nephrectomy as curative surgery for renal cancer.

A case of tumor implantation along the needle tract 20 months after needle aspiration of a renal cell carcinoma is reported. This rare but possible complication of needle aspiration should not discourage its use in the evaluation of renal mass lesions. Needle aspiration should be reserved for those patients in whom the clinical findings, roentgenograms and sonography indicate a benign process (that is to confirm that the mass is benign).

Extracorporeal shock wave lithotripsy (ESWL) is now the preferred method for treating most renal calculi. We designed a cassette and grid holder and a technique for filming in the water bath. The excellent film quality permits initial localization of small or faint calculi and confirmation of satisfactory fragmentation during ESWL. The technique facilitates patient treatment and throughput and should reduce the repeat treatment rate.

This cooperative study was sponsored by the National Prostatic Cancer Project to determine the usefulness of serum acid phosphatase levels as a predictive indicator with regard to performance status, sites of metastases, response to treatment, and survival in patients with advanced prostatic carcinoma. The results indicate that survival was significantly shorter for those patients who had elevation of thier on-study (pretreatment) total serum acid phosphatase ler cent reduction of primary tumor mass, relief of pain, and acid phosphatase activity. No correlation could be demonstrated between serum acid phosphatase and performance status, site of metastases, and other criteria of response to therapy. It is concluded that this test as currently determined spectrophotometrically at this stage of disease and if employed alone is not sufficient to allow for total evaluation of the response of therapy. It is, however, helpful when used in correlation with the previously mentioned positive factors.

Optimal management of men with diffuse incidental prostatic cancer (Stage A2) is an unresolved issue. Current forms of therapy include radical prostatectomy, external beam radiation therapy, and no treatment. Long-term results with curative therapy have been unreported because of the relatively recent substaging of Stage A into incidental and diffuse disease. The results of radical prostatectomy in 25 patients with Stage A2 prostatic cancer were reviewed. Incontinence was the most serious complication and occurred in four patients (16%). Pathologically, 24 patients (96%) had residual carcinoma present in the radical prostatectomy specimen. In 22 men (88%) the tumor was entirely confined to the prostate. Two patients (8%) demonstrated seminal vesicle invasion, and one (4%) had capsular penetration. In follow-up metastatic disease has developed in one patient, and another died without evidence of cancer. The remaining patients are alive without evidence of disease. Since 88% of men with Stage A2 disease have their tumor entirely confined to the prostate, radical prostatectomy offers an excellent chance of long-term cure, as in Stage B prostatic cancer.

In summary, the completed NPCP clinical trials have demonstrated that treatment with single antitumor agents and some combinations provide potential benefit to men with metastatic disease, both in those who have failed conventional hormonal therapy as well as those with newly diagnosed metastatic lesions. A summary of overall objective response rates in trials conducted on hormone-refractory patients is shown in Tables 17 and 18. In addition to demonstrating that chemotherapy can elicit a favorable response in patients with relapsing stage D disease, the NPCP has demonstrated that patients who respond to chemotherapy survive significantly longer than nonresponders. Furthermore, it has been demonstrated in these patients that objective partial regressions have been seen only with chemotherapy. Active single agents in prostatic cancer include methotrexate, cis-platinum, Estracyt, cyclophosphamide, 5-FU, DTIC, and streptozotocin. Finally, there may be some benefit in terms of response rate and survival when adding chemotherapy to conventional hormone therapy in patients with previously untreated stage D disease.

In summary, the management of the patient with disseminated bladder tumors can tax the knowledge and skills of the urologist who must also orchestrate and utilize the expertise of others in an attempt to prolong useful survival with chemotherapy while striving to provide maximum comfort by the prompt palliation of a variety of symptoms and problems which can occur.

Estramustine has been shown previously to be an effective drug in the treatment of metastatic prostatic cancer, demonstrating significant objective and subjective responses in long-term non-randomized trials and in other randomized trials. In this study prednimustine alone has shown a minimal over-all objective response rate of 12.9 percent of the cases, although with marked subjective improvement of pain relief and patient performance status. The combination of prednimustine with estramustine did not result in improvement of objective or subjective response parameters. The effects in terms of responses or in terms of toxicity for either agent were not additive when they were given in combination. Cross-over for those patients whose disease progressed on prednimustine therapy to estramustine had some benefit in over-all survival. Prednimustine alone or in combination with estramustine may be used safely and could improve markedly the quality of life for irradiated patients with advanced prostatic cancer who failed on hormonal treatment and have too poor a bone marrow reserve to be treated by other currently available myelosuppressive agents.