0022-5347 / 90/ 1433 -0538$02.00/ 0 Vol. 143, March
THE JOURNAL OF UROLOGY
Printed in U.S.A.
Copyright © 1990 by AMERICAN UROLOGICAL ASSO CIATION , INC.
NERVE-SPARING RADICAL PROSTATECTOMY: EVALUATION OF RESULTS AFTER 250 PATIENTS WILLIAM J. CATALONA
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AND
STEVEN W. BIGG
From the Division of Urologic Surgery, Washington University School of Medicine, St. Louis, Missouri
J._. ~~-:
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dolo \
ABSTRACT
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To examine the efficacy of nerve-sparing radical retropubic prostatectomy in preserving sexual potency and urinary continence, and in providing complete tumor excision we analyzed the records of the first 250 consecutive patients with clinical stage A or B prostate cancer treated since this operation was adopted at our institution. Over-all, sexual potency was preserved in 71 of 112 patients (63%) who underwent bilateral nerve-sparing prostatectomy and 13 of 33 (39%) who underwent a unilateral nerve-sparing procedure with a minimum of 6 months of followup. Preservation of potency correlated with patient age (p equals 0.0035, chi-square) and was significantly (p less than 0.001, chi-square) higher in patients with pathologically organ-confined tumors (72%) than in those with pathologically extracapsular tumors (51%). Of 192 patients followed for at least 6 months 188 (98 %) achieved urinary continence postoperatively. Over-all, apparent complete tumor excision as defined by organ-confined tumor with negative surgical margins and undetectable postoperative prostate specific antigen levels was achieved in 14 preoperatively potent patients (42 %) who underwent a unilateral and 67 (59%) who underwent a bilateral nerve-sparing procedure. Completeness of tumor excision correlated with tumor stage. In approximately 45% of the patients incomplete tumor excision was owing to seminal vesicle and/or lymph node involvement or positive bladder neck margins that could not be attributed to the nerve-sparing modification. However, improper application of the nerve-sparing technique may have contributed in the others. We were unable to detect microscopic penetration of the capsule or distinguish between gross extracapsular tumor extension and periprostatic fibrosis at operation. We conclude that with proper application of nerve-sparing radical retropubic prostatectomy, potency can be preserved in the majority of patients without compromising the adequacy of tumor excision. The completeness of tumor excision appears to be determined primarily by the extent of the tumor. Therefore, patient selection is important. Patients with focal, well differentiated tumors are ideal candidates for a nerve-sparing procedure, while those with high volume, poorly differentiated tumors may be at a higher risk for positive surgical margins. The benefits of wide excision of the neurovascular bundles remain to be demonstrated formally. (J. Ural. , 143: 538-544, 1990)
In 1983 Walsh and associates introduced the nerve-sparing modification of radical retropubic prostatectomy in which the prostate is excised without injuring the neurovascular bundles that contain the cavernous nerves and vessels to preserve erectile potency.1 Since then, Walsh has modified and improved upon this operation and has demonstrated that with the nervesparing technique potency can be preserved in the majority of patients with organ-confined tumors.2• 3 Moreover, he has shown that 1 or both neurovascular bundles can be sacrificed deliberately in patients with evidence of extraprostatic tumor extension at operation. In so doing it is possible to obtain wider margins of resection than usually are achieved with either standard radical perineal or radical retropubic prostatectomy.4 Walsh and associates also demonstrated that erectile potency is preserved in the majority of patients in whom only 1 neurovascular bundle has been excised.5 Other than these studies, there have been few reports on the results of nerve-sparing radical prostatectomy.6- 8 We adopted the nerve-sparing radical prostatectomy in May 1983 and reported on our early results in 40 patients in 1985,6 documenting postoperative return of erectile function and correlating the incidence of positive surgical margins with the clinical stage of tumor and the technique of prostatectomy used (standard versus nerve-sparing). In the present study we analyzed and updated our results in achieving preservation of continence, potency and complete tumor excision in 250 consecutive patients treated with radical prostatectomy since the Accepted for publication September 18, 1989.
nerve-sparing modification was adopted at our institution. We correlated our results with relevant clinical parameters, and also evaluated our ability to distinguish accurately between periprostatic fibrosis and extracapsular tumor extension at operation. The results have altered our approach to radical prostatectomy in some patients with clinically localized prostate cancer. PATIENTS AND METHODS
Patients. A total of 250 consecutive private patients treated by 1 of us (W. J. C.) with clinical stage A or B prostate cancer underwent pelvic lymphadenectomy and radical retropubic prostatectomy between May 6, 1983 and November 30, 1988 using a technique similar to that described by Walsh and associates. 1- 3 All patients had negative pelvic lymph nodes on frozen section at operation. Clinical staging. The disease in all patients was staged with enzymatic serum prostatic acid phosphatase determinations using the thymolphthalein monophosphate substrate and radionuclide bone scans. Most patients also were evaluated by prostate specific antigen levels and pelvic computerized tomographic (CT) scans. Many patients also were evaluated with transrectal prostatic ultrasonography or magnetic resonance imaging. With a modification of the Whitmore-Jewett system the patients were classified as having clinical stage Al disease if they had clinically unsuspected well differentiated prostate cancer in fewer than 5% of a prostatectomy specimen removed
538
539
NERVE-SPARING RADICAL PROSTATECTOMY
for presumed benign hyperplasia. They were considered to have stage A2 disease if more than 5% of the specimen was involved, or if there was moderately or poorly differentiated carcinoma. Patients were classified as having clinical stage B 1 disease if they had palpable carcinoma of less than 2 cm. in diameter involving less than 1 lobe of the prostate and judged to be confined within the prostatic capsule. Stage B2 disease denoted palpable tumors involving both lobes of the prostate or induration of greater than 2 cm. in diameter judged to be confined within the prostatic capsule. All patients with clinical stage A or B disease (except 1) had a normal serum acid phosphatase level and a bone scan with confirmatory radiographs that showed no evidence of metastases. Findings on pelvic CT scans, transrectal prostatic ultrasonography or magnetic resonance imaging were not considered sufficient to exclude these patients from radical prostatectomy. Examination of surgical specimens. At operation the bladder neck and urethral margins were removed from the prostate by grasping the retracted urethra, including its mucosa! edges, with small Allis forceps and circumferentially excising the 2 to 3 mm. urethral stump. The bladder neck similarly was excised circumferentially, including the mucosa! edges and bladder neck muscle. These margins were sent as separate specimens. If the histological examination revealed cancer the surgical margins were considered to be positive. The excised prostate was dipped in india ink and immediately fixed in Bouin's solution to prevent the india ink from spreading into the tissue planes. The specimen then was "breadloafed" in 2 to 5 mm. segments, depending on the size of the gland, and fixed overnight in 10% phosphate buffered formalin solution. Then, 3 hematoxylin and eosin-stained sections from the right half and 3 from the left half of the prostate were examined for the peripheral surgical margins. In addition, 2 longitudinal sections through the base of the seminal vesicles were examined on each side. Two longitudinal sections through the apex of the prostate also were examined. The presence of cancer at the prostatic apex but not in the urethral margin was considered to be a positive anterior and/or posterior margin. If the tumor extended to an inked margin it was called a positive lateral, anterior or posterior surgical margin. Pathological staging. Pathological stages A and B were defined as for clinical staging except that the stage was verified histologically. Pathological stage C was divided into substages: stage Cl denoted microscopic extracapsular tumor extension and stage C2 referred to tumor extension to the fascia surrounding the seminal vesicles or the muscular walls of the seminal vesicle(s) proper with or without microscopically positive margins. Pathological stage Dl referred to patients with clinical stage A or B disease who at pelvic lymphadenectomy had histologically documented lymph node metastases. Organ-confined disease referred to patients with pathological stage A or B cancer. Extracapsular disease denoted pathological stage C or D tumor, and included all patients with positive margins of resection. Tumor grading. Tumors were graded according to the system used at Barnes Hospital into well, moderate or poorly differentiated adenocarcinoma. Followup. Patients were followed at 3 to 6-month intervals for 2 years and thereafter at approximately 6-month intervals. The last date of followup for this analysis was January 4, 1989. At followup a history, digital rectal examination, prostate specific antigen level and acid phosphatase determinations were obtained. Bone scans, CT scans or other tests were not performed routinely unless clinically indicated. Preoperative and postoperative erectile function. Preoperative and postoperative erectile function was determined by history. Information also was obtained from sexual partners when feasible. Postoperatively, the patient was classified as potent if the erection was sufficient for vaginal penetration and sexual
intercourse or not potent if the erection was insufficient for vaginal penetration. Urinary continence. The patients were considered to be continent if they did not require a protective pad to keep the clothing dry. Patients who were dry under virtually all normal ) circumstances but who elected to wear a precautionary pad for occasional leakage of a few drops of urine with severe coughing or straining also were considered as being continent. Nerve-sparing procedure. Throughout t his series our primary goal was to achieve complete tumor excision with preservation of potency being of secondary importance. In patients in whom evidence suggested gross extracapsular tumor extension at operation the neurovascular bundle in question was deliberately sacrificed by wide ipsilateral excision, dissecting the bundle off of the anterior surface of the rectum. In patients who were not potent preoperatively no attempt was made to preserve the neurovascular bundles. In these patients the bundles were taken wider (as in our former standard radical prostatectomy) than in potent patients but the entire neurovascular bundles were not deliberately and completely dissected off the anterior rectal wall (as in a superradical prostatectomy) unless there was evidence of extracapsular tumor extension. RESULTS
Patient age. Mean patient age over-all was 64 years (table 1). The mean age was 61 years for patients with clinical stage Al, 65 for those with stage A2, 62 for t hose with stage Bl and 65 for those with stage B2 disease. Clinical stage. Of the patients 13 had clinical stage Al, 40 stage A2, 82 stage Bl and 115 stage B2 disease (table 2). All except 1 patient had normal preoperative serum prostatic acid 1. Comparison of the preservation of potency as a func tion of clinical stage, age and type of nerve-sparing procedure performed in patients who were potent preoperatively and were followed for at least 6 months
TABLE
Clinical Stage
Pt. Age
U nilat. Procedure No. Potent/ Total (%)
40-49 50- 59 60-69 70-79
Al
Totals 40-49 50- 59 60-69 70- 79
A2
40-49 50-59 60- 69 70- 79
Totals B2
(0)
2/3 0/1 2/5
(67) (0) (40)
0/2
(0)
(0) 0/2 1/1 (100) (0) 0/ 1 2/ 3 (67) 2/ 2 (100) 5/7 (71)
Totals Bl
0/1
Bilat. Procedure No. Potent/ Total(%)
40-49 50- 59 60- 69 70-79
Totals
(80) (50)
5/7 0/ 1 2/3 5/ 10 2/ 4 9/18
(71) (0) (67) (50) (50) (50)
(25) (20) (60) (32)
(67) 2/ 3 15/ 17 (88) 13/24 (54) (0) 0/1 30/45 (67) 1/ 1 (100) 10/12 (83) 14/22 (64) (20) 2/7 27/ 42 (64)
13/33 (39)
71/ 112 (63)
1/4 2/10 3/5 6/19
Totals
4/5 1/2
Relationship between clinical and pathological stage in 250 consecutive patients undergoing radical prostatectomy
TABLE 2.
Clinical Stage Al A2 Bl B2 Totals
Pathological Stage T otals Al
A2
7
6 26
7
32
Bl
B2
Cl
C2
01
48
16 39
8
55
0 2 0 30
0 0 0
48
0 12 18 38
68
32
8
13 40 82 115 250
r,.A;,
540
CATALONA AND BIGG
phosphatase levels. The patient with an elevated acid phosphatase titer was believed to have hepatic dysfunction. It was considered that the acid phosphatase titer may have been elevated on this basis. Thus, he was offered radical prostatectomy. A pathologically organ-confined tumor was found and postoperatively this patient maintained an undetectable prostate specific antigen level with persistent mild elevation of acid phosphatase and no evidence of recurrent tumor for 24 months. Of 53 patients classified as having clinical stage A disease 45 (85%) were referred for radical prostatectomy after transurethral prostatectomy had been done elsewhere for clinical benign hyperplasia. Many of these patients had palpable abnormalities in the prostate gland after transurethral resection. However, it was impossible to distinguish between postoperative changes and baseline abnormalities. Therefore, these patients were classified as having clinical stage Al or A2 disease as stated previously. Pathological stage. Pathological stage was Al in 7 patients, vf A2 in 32, Bl in 48, B2 in 55, Cl in 68, C2 in 32 and Dl in 8. (15, All but 1 patient with patholo ical sta e Cl disease had ositive i;;urgica margins. Many of these patients had multiple sites of capsular penetration. We did not observe a case in which ~ e was capsular penetrationexcTusivelyin-tne regionoftlie neurov~ar15un e that was covere -by"tl1e bunaie wiUia negative surgical margin. The distribution of pathological stages as a function of clinical stage is shown in table 2. None of the 13 stage Al cancer patients had extraprostatic tumor spread, although 6 had more extensive or more undifferentiated tumor within the prostate. In contrast, the disease in 14 of 40 patients (30%) with stage A2, 18 of 82 (22%) with stage B 1 and 76 of 115 (68 %) with stage B2 cancer was clinically understaged. Over-all, clinical understaging occurred in 108 of the 250 patients (43%) with clinical stage A or B prostate cancer. Tumor grade in relation to clinical understaging. Occasionally, there was a discrepancy between the tumor grade of the diagnostic biopsy and that of the radical prostatectomy specimen. This topic has been considered in detail previously9 and will not be addressed further. Clinical understaging occurred in 18 of 75 patients (24%) with well differentiated, 65 of 143 (45%) with moderately differentiated and 25 of 32 (78%) with poorly differentiated tumors. The correlation between tumor grade and clinical understaging was significant at a 0.00001 level by chi-square analysis. Nerve-sparing procedure. Deliberate wide excision of the neurovascular bundle was performed unilaterally in 62 patients (25%) and bilaterally in 13 (5%). In the remaining patients who were potent preoperatively an attempt was made to mobilize the prostate medial and anterior to the neurovascular bundles. In most patients the retrograde approach as described by Walsh 3 was used. However, in some patients in whom the plane between the prostate and rectum was obliterated at the prostatic apex an antegrade approach was used. The relationship between clinical stage and the attempt to perform bilateral or unilateral nerve-sparing is shown in table
61
TABLE
3. Type of nerve-sparing procedure performed as a function of clinical stage in 250 consecutive patients Nerve-Sparing Procedure
Clinical Stage Al A2 Bl B2 Totals
Bilat.• No.(%)
Unilat.* No.(%)
8 32 68 67 175
5 5 13 39 62
(61) (80) (83) (58) (70)
(38) (13) (16) (34) (25)
None No.(%) 0 3 1 9 13
(7) (1) (8) (5)
Total No. 13 40 82 115 250
* Not all of these patients were potent preoperatively. In impotent patients neurovascular bundles were not widely excised unless there was evidence of tumor extension.
TABLE 4. Preservation of potency as a function of pathological stage and the type of nerve-sparing procedure performed in 145 patients who were potent preoperatively and followed for 6 months or longer
Pathological Stage A B Cl C2 Dl Totals
U nilat. Procedure No./Total (%) 2/6 5/9 3/11 2/5 1/2 13/33
(33) (56) (27) (40) (50) (39)
Bilat. Procedure No./Total (%) 12/19 36/48 15/29 6/12 2/4 71/112
(63) (75) (52) (50) (50) (63)
3. Bilateral nerve-sparing was attempted in 61 % of the patients with clinical stage Al, 80% with stage A2, 83% with stage Bl but only 58% with stage B2 tumors. Unilateral nerve-sparing was attempted in 38% of the patients with stage Al, 13% with stage A2, 16% with stage Bl and 34% with stage B2 tumors. Followup. Of the patients 58 were followed for less than 6 months postoperatively, 192 for at least 6 months, 161 for 12 months, 102 for 24 months, 61 for 36 months, 28 for 48 months and 6 for 60 months. Complications. The complications of urinary incontinence and sexual impotency are addressed. Other postoperative complications will be the topic of a separate report and will not be discussed further in this study. Postoperative urinary continence. Among 92 patients who were followed for at least 6 months postoperatively 188 (98%) are continent. No patient had total urinary incontinence but 4 have required the use of pads to keep the clothing dry. Preservation of potency. Over-all, 180 of the 250 patients (72%) were potent preoperatively but only 145 fulfilled the criteria of being potent preoperatively, having undergone either a unilateral or bilateral nerve-sparing procedure and being eligible for at least 6 months of followup. Of these patients 71 of 112 (63%) who underwent bilateral nerve-sparing (tables 1, 4 and 5) and 13 of 33 (39%) who underwent unilateral nervesparing (tables 4 and 5) had potency preserved (table 1). Bilateral nerve-sparing procedure: patient age, tumor stage and potency. The interrelationships among patient age, clinic;al stage and preservation of potency in patients who underwent a bilateral nerve-sparing procedure are shown in table 1. Potency was preserved in 71 % of the patients with clinical stage Al, 50% with stage A2, 67% with stage Bl and 64% with stage B2 disease. Potency was preserved in 81 % of the patients 40 to 59 years old, 57% of those 60 to 69 years old and 33% of those 70 to 79 years old. This correlation between patient age and preservation of potency is statistically significant (p = 0.0035, chi-square) . The relationship of pathological stage to preservation of potency in patients who underwent a bilateral nerve-sparing procedure is shown in table 4. Potency was preserved in 63% of the patients with pathological stage A, 75% with stage B, 52% with stage Cl, 50% with stage C2 and 50% with stage Dl disease. The correlation between preservation of potency in patients with organ-confined tumors versus those with extracapsular extension is significant (p
THE JOURNAL OF UROLOGY
Printed in U.S.A.
Copyright © 1990 by AMERICAN UROLOGICAL ASSO CIATION , INC.
NERVE-SPARING RADICAL PROSTATECTOMY: EVALUATION OF RESULTS AFTER 250 PATIENTS WILLIAM J. CATALONA
\
, ..»'-G3\
_ \ )~ ~
0,V
~
'\
/
AND
STEVEN W. BIGG
From the Division of Urologic Surgery, Washington University School of Medicine, St. Louis, Missouri
J._. ~~-:
"
dolo \
ABSTRACT
W'':::J:.. ~ c...,# ~
\)
~
·\
To examine the efficacy of nerve-sparing radical retropubic prostatectomy in preserving sexual potency and urinary continence, and in providing complete tumor excision we analyzed the records of the first 250 consecutive patients with clinical stage A or B prostate cancer treated since this operation was adopted at our institution. Over-all, sexual potency was preserved in 71 of 112 patients (63%) who underwent bilateral nerve-sparing prostatectomy and 13 of 33 (39%) who underwent a unilateral nerve-sparing procedure with a minimum of 6 months of followup. Preservation of potency correlated with patient age (p equals 0.0035, chi-square) and was significantly (p less than 0.001, chi-square) higher in patients with pathologically organ-confined tumors (72%) than in those with pathologically extracapsular tumors (51%). Of 192 patients followed for at least 6 months 188 (98 %) achieved urinary continence postoperatively. Over-all, apparent complete tumor excision as defined by organ-confined tumor with negative surgical margins and undetectable postoperative prostate specific antigen levels was achieved in 14 preoperatively potent patients (42 %) who underwent a unilateral and 67 (59%) who underwent a bilateral nerve-sparing procedure. Completeness of tumor excision correlated with tumor stage. In approximately 45% of the patients incomplete tumor excision was owing to seminal vesicle and/or lymph node involvement or positive bladder neck margins that could not be attributed to the nerve-sparing modification. However, improper application of the nerve-sparing technique may have contributed in the others. We were unable to detect microscopic penetration of the capsule or distinguish between gross extracapsular tumor extension and periprostatic fibrosis at operation. We conclude that with proper application of nerve-sparing radical retropubic prostatectomy, potency can be preserved in the majority of patients without compromising the adequacy of tumor excision. The completeness of tumor excision appears to be determined primarily by the extent of the tumor. Therefore, patient selection is important. Patients with focal, well differentiated tumors are ideal candidates for a nerve-sparing procedure, while those with high volume, poorly differentiated tumors may be at a higher risk for positive surgical margins. The benefits of wide excision of the neurovascular bundles remain to be demonstrated formally. (J. Ural. , 143: 538-544, 1990)
In 1983 Walsh and associates introduced the nerve-sparing modification of radical retropubic prostatectomy in which the prostate is excised without injuring the neurovascular bundles that contain the cavernous nerves and vessels to preserve erectile potency.1 Since then, Walsh has modified and improved upon this operation and has demonstrated that with the nervesparing technique potency can be preserved in the majority of patients with organ-confined tumors.2• 3 Moreover, he has shown that 1 or both neurovascular bundles can be sacrificed deliberately in patients with evidence of extraprostatic tumor extension at operation. In so doing it is possible to obtain wider margins of resection than usually are achieved with either standard radical perineal or radical retropubic prostatectomy.4 Walsh and associates also demonstrated that erectile potency is preserved in the majority of patients in whom only 1 neurovascular bundle has been excised.5 Other than these studies, there have been few reports on the results of nerve-sparing radical prostatectomy.6- 8 We adopted the nerve-sparing radical prostatectomy in May 1983 and reported on our early results in 40 patients in 1985,6 documenting postoperative return of erectile function and correlating the incidence of positive surgical margins with the clinical stage of tumor and the technique of prostatectomy used (standard versus nerve-sparing). In the present study we analyzed and updated our results in achieving preservation of continence, potency and complete tumor excision in 250 consecutive patients treated with radical prostatectomy since the Accepted for publication September 18, 1989.
nerve-sparing modification was adopted at our institution. We correlated our results with relevant clinical parameters, and also evaluated our ability to distinguish accurately between periprostatic fibrosis and extracapsular tumor extension at operation. The results have altered our approach to radical prostatectomy in some patients with clinically localized prostate cancer. PATIENTS AND METHODS
Patients. A total of 250 consecutive private patients treated by 1 of us (W. J. C.) with clinical stage A or B prostate cancer underwent pelvic lymphadenectomy and radical retropubic prostatectomy between May 6, 1983 and November 30, 1988 using a technique similar to that described by Walsh and associates. 1- 3 All patients had negative pelvic lymph nodes on frozen section at operation. Clinical staging. The disease in all patients was staged with enzymatic serum prostatic acid phosphatase determinations using the thymolphthalein monophosphate substrate and radionuclide bone scans. Most patients also were evaluated by prostate specific antigen levels and pelvic computerized tomographic (CT) scans. Many patients also were evaluated with transrectal prostatic ultrasonography or magnetic resonance imaging. With a modification of the Whitmore-Jewett system the patients were classified as having clinical stage Al disease if they had clinically unsuspected well differentiated prostate cancer in fewer than 5% of a prostatectomy specimen removed
538
539
NERVE-SPARING RADICAL PROSTATECTOMY
for presumed benign hyperplasia. They were considered to have stage A2 disease if more than 5% of the specimen was involved, or if there was moderately or poorly differentiated carcinoma. Patients were classified as having clinical stage B 1 disease if they had palpable carcinoma of less than 2 cm. in diameter involving less than 1 lobe of the prostate and judged to be confined within the prostatic capsule. Stage B2 disease denoted palpable tumors involving both lobes of the prostate or induration of greater than 2 cm. in diameter judged to be confined within the prostatic capsule. All patients with clinical stage A or B disease (except 1) had a normal serum acid phosphatase level and a bone scan with confirmatory radiographs that showed no evidence of metastases. Findings on pelvic CT scans, transrectal prostatic ultrasonography or magnetic resonance imaging were not considered sufficient to exclude these patients from radical prostatectomy. Examination of surgical specimens. At operation the bladder neck and urethral margins were removed from the prostate by grasping the retracted urethra, including its mucosa! edges, with small Allis forceps and circumferentially excising the 2 to 3 mm. urethral stump. The bladder neck similarly was excised circumferentially, including the mucosa! edges and bladder neck muscle. These margins were sent as separate specimens. If the histological examination revealed cancer the surgical margins were considered to be positive. The excised prostate was dipped in india ink and immediately fixed in Bouin's solution to prevent the india ink from spreading into the tissue planes. The specimen then was "breadloafed" in 2 to 5 mm. segments, depending on the size of the gland, and fixed overnight in 10% phosphate buffered formalin solution. Then, 3 hematoxylin and eosin-stained sections from the right half and 3 from the left half of the prostate were examined for the peripheral surgical margins. In addition, 2 longitudinal sections through the base of the seminal vesicles were examined on each side. Two longitudinal sections through the apex of the prostate also were examined. The presence of cancer at the prostatic apex but not in the urethral margin was considered to be a positive anterior and/or posterior margin. If the tumor extended to an inked margin it was called a positive lateral, anterior or posterior surgical margin. Pathological staging. Pathological stages A and B were defined as for clinical staging except that the stage was verified histologically. Pathological stage C was divided into substages: stage Cl denoted microscopic extracapsular tumor extension and stage C2 referred to tumor extension to the fascia surrounding the seminal vesicles or the muscular walls of the seminal vesicle(s) proper with or without microscopically positive margins. Pathological stage Dl referred to patients with clinical stage A or B disease who at pelvic lymphadenectomy had histologically documented lymph node metastases. Organ-confined disease referred to patients with pathological stage A or B cancer. Extracapsular disease denoted pathological stage C or D tumor, and included all patients with positive margins of resection. Tumor grading. Tumors were graded according to the system used at Barnes Hospital into well, moderate or poorly differentiated adenocarcinoma. Followup. Patients were followed at 3 to 6-month intervals for 2 years and thereafter at approximately 6-month intervals. The last date of followup for this analysis was January 4, 1989. At followup a history, digital rectal examination, prostate specific antigen level and acid phosphatase determinations were obtained. Bone scans, CT scans or other tests were not performed routinely unless clinically indicated. Preoperative and postoperative erectile function. Preoperative and postoperative erectile function was determined by history. Information also was obtained from sexual partners when feasible. Postoperatively, the patient was classified as potent if the erection was sufficient for vaginal penetration and sexual
intercourse or not potent if the erection was insufficient for vaginal penetration. Urinary continence. The patients were considered to be continent if they did not require a protective pad to keep the clothing dry. Patients who were dry under virtually all normal ) circumstances but who elected to wear a precautionary pad for occasional leakage of a few drops of urine with severe coughing or straining also were considered as being continent. Nerve-sparing procedure. Throughout t his series our primary goal was to achieve complete tumor excision with preservation of potency being of secondary importance. In patients in whom evidence suggested gross extracapsular tumor extension at operation the neurovascular bundle in question was deliberately sacrificed by wide ipsilateral excision, dissecting the bundle off of the anterior surface of the rectum. In patients who were not potent preoperatively no attempt was made to preserve the neurovascular bundles. In these patients the bundles were taken wider (as in our former standard radical prostatectomy) than in potent patients but the entire neurovascular bundles were not deliberately and completely dissected off the anterior rectal wall (as in a superradical prostatectomy) unless there was evidence of extracapsular tumor extension. RESULTS
Patient age. Mean patient age over-all was 64 years (table 1). The mean age was 61 years for patients with clinical stage Al, 65 for those with stage A2, 62 for t hose with stage Bl and 65 for those with stage B2 disease. Clinical stage. Of the patients 13 had clinical stage Al, 40 stage A2, 82 stage Bl and 115 stage B2 disease (table 2). All except 1 patient had normal preoperative serum prostatic acid 1. Comparison of the preservation of potency as a func tion of clinical stage, age and type of nerve-sparing procedure performed in patients who were potent preoperatively and were followed for at least 6 months
TABLE
Clinical Stage
Pt. Age
U nilat. Procedure No. Potent/ Total (%)
40-49 50- 59 60-69 70-79
Al
Totals 40-49 50- 59 60-69 70- 79
A2
40-49 50-59 60- 69 70- 79
Totals B2
(0)
2/3 0/1 2/5
(67) (0) (40)
0/2
(0)
(0) 0/2 1/1 (100) (0) 0/ 1 2/ 3 (67) 2/ 2 (100) 5/7 (71)
Totals Bl
0/1
Bilat. Procedure No. Potent/ Total(%)
40-49 50- 59 60- 69 70-79
Totals
(80) (50)
5/7 0/ 1 2/3 5/ 10 2/ 4 9/18
(71) (0) (67) (50) (50) (50)
(25) (20) (60) (32)
(67) 2/ 3 15/ 17 (88) 13/24 (54) (0) 0/1 30/45 (67) 1/ 1 (100) 10/12 (83) 14/22 (64) (20) 2/7 27/ 42 (64)
13/33 (39)
71/ 112 (63)
1/4 2/10 3/5 6/19
Totals
4/5 1/2
Relationship between clinical and pathological stage in 250 consecutive patients undergoing radical prostatectomy
TABLE 2.
Clinical Stage Al A2 Bl B2 Totals
Pathological Stage T otals Al
A2
7
6 26
7
32
Bl
B2
Cl
C2
01
48
16 39
8
55
0 2 0 30
0 0 0
48
0 12 18 38
68
32
8
13 40 82 115 250
r,.A;,
540
CATALONA AND BIGG
phosphatase levels. The patient with an elevated acid phosphatase titer was believed to have hepatic dysfunction. It was considered that the acid phosphatase titer may have been elevated on this basis. Thus, he was offered radical prostatectomy. A pathologically organ-confined tumor was found and postoperatively this patient maintained an undetectable prostate specific antigen level with persistent mild elevation of acid phosphatase and no evidence of recurrent tumor for 24 months. Of 53 patients classified as having clinical stage A disease 45 (85%) were referred for radical prostatectomy after transurethral prostatectomy had been done elsewhere for clinical benign hyperplasia. Many of these patients had palpable abnormalities in the prostate gland after transurethral resection. However, it was impossible to distinguish between postoperative changes and baseline abnormalities. Therefore, these patients were classified as having clinical stage Al or A2 disease as stated previously. Pathological stage. Pathological stage was Al in 7 patients, vf A2 in 32, Bl in 48, B2 in 55, Cl in 68, C2 in 32 and Dl in 8. (15, All but 1 patient with patholo ical sta e Cl disease had ositive i;;urgica margins. Many of these patients had multiple sites of capsular penetration. We did not observe a case in which ~ e was capsular penetrationexcTusivelyin-tne regionoftlie neurov~ar15un e that was covere -by"tl1e bunaie wiUia negative surgical margin. The distribution of pathological stages as a function of clinical stage is shown in table 2. None of the 13 stage Al cancer patients had extraprostatic tumor spread, although 6 had more extensive or more undifferentiated tumor within the prostate. In contrast, the disease in 14 of 40 patients (30%) with stage A2, 18 of 82 (22%) with stage B 1 and 76 of 115 (68 %) with stage B2 cancer was clinically understaged. Over-all, clinical understaging occurred in 108 of the 250 patients (43%) with clinical stage A or B prostate cancer. Tumor grade in relation to clinical understaging. Occasionally, there was a discrepancy between the tumor grade of the diagnostic biopsy and that of the radical prostatectomy specimen. This topic has been considered in detail previously9 and will not be addressed further. Clinical understaging occurred in 18 of 75 patients (24%) with well differentiated, 65 of 143 (45%) with moderately differentiated and 25 of 32 (78%) with poorly differentiated tumors. The correlation between tumor grade and clinical understaging was significant at a 0.00001 level by chi-square analysis. Nerve-sparing procedure. Deliberate wide excision of the neurovascular bundle was performed unilaterally in 62 patients (25%) and bilaterally in 13 (5%). In the remaining patients who were potent preoperatively an attempt was made to mobilize the prostate medial and anterior to the neurovascular bundles. In most patients the retrograde approach as described by Walsh 3 was used. However, in some patients in whom the plane between the prostate and rectum was obliterated at the prostatic apex an antegrade approach was used. The relationship between clinical stage and the attempt to perform bilateral or unilateral nerve-sparing is shown in table
61
TABLE
3. Type of nerve-sparing procedure performed as a function of clinical stage in 250 consecutive patients Nerve-Sparing Procedure
Clinical Stage Al A2 Bl B2 Totals
Bilat.• No.(%)
Unilat.* No.(%)
8 32 68 67 175
5 5 13 39 62
(61) (80) (83) (58) (70)
(38) (13) (16) (34) (25)
None No.(%) 0 3 1 9 13
(7) (1) (8) (5)
Total No. 13 40 82 115 250
* Not all of these patients were potent preoperatively. In impotent patients neurovascular bundles were not widely excised unless there was evidence of tumor extension.
TABLE 4. Preservation of potency as a function of pathological stage and the type of nerve-sparing procedure performed in 145 patients who were potent preoperatively and followed for 6 months or longer
Pathological Stage A B Cl C2 Dl Totals
U nilat. Procedure No./Total (%) 2/6 5/9 3/11 2/5 1/2 13/33
(33) (56) (27) (40) (50) (39)
Bilat. Procedure No./Total (%) 12/19 36/48 15/29 6/12 2/4 71/112
(63) (75) (52) (50) (50) (63)
3. Bilateral nerve-sparing was attempted in 61 % of the patients with clinical stage Al, 80% with stage A2, 83% with stage Bl but only 58% with stage B2 tumors. Unilateral nerve-sparing was attempted in 38% of the patients with stage Al, 13% with stage A2, 16% with stage Bl and 34% with stage B2 tumors. Followup. Of the patients 58 were followed for less than 6 months postoperatively, 192 for at least 6 months, 161 for 12 months, 102 for 24 months, 61 for 36 months, 28 for 48 months and 6 for 60 months. Complications. The complications of urinary incontinence and sexual impotency are addressed. Other postoperative complications will be the topic of a separate report and will not be discussed further in this study. Postoperative urinary continence. Among 92 patients who were followed for at least 6 months postoperatively 188 (98%) are continent. No patient had total urinary incontinence but 4 have required the use of pads to keep the clothing dry. Preservation of potency. Over-all, 180 of the 250 patients (72%) were potent preoperatively but only 145 fulfilled the criteria of being potent preoperatively, having undergone either a unilateral or bilateral nerve-sparing procedure and being eligible for at least 6 months of followup. Of these patients 71 of 112 (63%) who underwent bilateral nerve-sparing (tables 1, 4 and 5) and 13 of 33 (39%) who underwent unilateral nervesparing (tables 4 and 5) had potency preserved (table 1). Bilateral nerve-sparing procedure: patient age, tumor stage and potency. The interrelationships among patient age, clinic;al stage and preservation of potency in patients who underwent a bilateral nerve-sparing procedure are shown in table 1. Potency was preserved in 71 % of the patients with clinical stage Al, 50% with stage A2, 67% with stage Bl and 64% with stage B2 disease. Potency was preserved in 81 % of the patients 40 to 59 years old, 57% of those 60 to 69 years old and 33% of those 70 to 79 years old. This correlation between patient age and preservation of potency is statistically significant (p = 0.0035, chi-square) . The relationship of pathological stage to preservation of potency in patients who underwent a bilateral nerve-sparing procedure is shown in table 4. Potency was preserved in 63% of the patients with pathological stage A, 75% with stage B, 52% with stage Cl, 50% with stage C2 and 50% with stage Dl disease. The correlation between preservation of potency in patients with organ-confined tumors versus those with extracapsular extension is significant (p
