eMedicine Specialties > Urology > Cancer, Prostate
Prostate Cancer - Radical Retropubic Prostatectomy: Follow-up
Updated: Apr 27, 2009
Outcome and Prognosis
This section presents outcome analysis with respect to cancer control and survival data after radical prostatectomy and the role of radical prostatectomy in each clinical stage group.
The Partin tables are adjuncts for predicting prostate cancer spread and prognosis. The recently devised Kattan nomograms can be used to predict outcomes after different modalities for the treatment of prostate cancer. Using readily available pocket software, the clinician can enter preoperative data and advise the patient concerning the likelihood of organ confinement and outcomes after radical prostatectomy. Chances for recurrence after radical prostatectomy can also be calculated using the pathologic data. This guides the clinician in devising treatment strategy.
Clinical stages T1a and T1b
This subcategory refers to prostate cancer incidentally detected during transurethral resection of the prostate. Clinical stage T1a refers to low-grade or medium-grade cancer in less than 5% of the resected chips, and T1b refers to high-grade cancer or any grade cancer in more than 5% of the resected chips. In a series from the Mayo Clinic, T1a and T1b tumors constituted 1.5% and 5.6% of all clinically organ-confined tumors, respectively.27 Eighty-eight percent of T1a tumors were pathologically organ-confined at the time of radical prostatectomy, as opposed to 68% of T1b tumors. Significant understaging was evident, especially in the T1b group.
Several series reveal that the likelihood of finding significant tumor on examination of the radical prostatectomy specimen for T1a disease ranges from 12-20%. In one series, low-grade tumors (ie, Gleason score ≤3) were not associated with extracapsular extension, but 60% of those with a Gleason score of 7 or above had extracapsular extension. These clinical stages could represent significant prostate cancers. A significant portion of these patients could harbor cancer in the peripheral zone. In one series, two thirds of patients had cancer distal to the verumontanum. Cause-specific survival differences in these 2 subcategories became more significant, especially after 10 years.
Currently, the authors recommend radical prostatectomy as a viable treatment option for young healthy patients with a life expectancy of more than 10-15 years and T1a disease. Observation may be a viable treatment option, along with careful follow-up, serial serum PSA testing, digital rectal examination, and ultrasonography with biopsy, when indicated. All cases of significant residual disease (ie, clinical stage T1b, high-grade T1a disease) warrant early treatment with radical prostatectomy.
Clinical stages T1c and T2
Since the advent of serum PSA testing, physicians have detected more prostate cancers at an earlier stage. In the authors' contemporary radical prostatectomy series, 45% of patients present with clinical stage T1c disease and 45% present with clinical stage T2 disease. Based on the relationship of tumor volume, grade, DNA ploidy, and likelihood of disease progression, previous studies have shown that 84-92% of c-T1c tumors are clinically significant and warrant definitive treatment.
A comparison of PSA-detected nonpalpable prostate cancers (c-T1c) and digitally palpable (c-T2) prostate cancers treated with radical prostatectomy in 4453 patients from 1987-1995 was performed at the Mayo Clinic.28 One thousand and forty-one patients had T1c disease, 1076 patients had T2a disease, and 2336 patients had T2b/c disease.
Overall, 76%, 71%, and 54% of patients with clinical stage T1c, T2a, and T2b/c lesions had organ-confined disease (less than p-T2c) at the time of prostatectomy, respectively. The pathologic stage, Gleason score, and DNA ploidy pattern were comparable in clinical T1c and T2a disease. Progression-free survival (systemic or local and PSA level progression [>0.2 mg/mL]) was also comparable in these two groups but was significantly worse in the c-T2b/c group. Seven-year survival rates in clinical T1c, T2a, and T2b/c tumors free of systemic or local progression were 96%, 92%, and 89% respectively (P <.0001 [Image 8]). For clinical T1c, T2a, and T2b/c tumors, the 7-year survivals free of PSA progression were 73%, 75%, and 66% respectively (P <.0001 [Image 9]).
Kaplan-Meier clinical progression (ie, systemic/local) survival estimates for 4453 patients with clinically localized prostate cancer treated with radical prostatectomy with and without adjuvant therapy. Numbers in parentheses represent standard error and number of patients at risk at that point. Reprinted from Ghavamian R, Blute ML, Bergstralh EJ, et al. Comparison of clinically nonpalpable prostate-specific antigen-detected (cT1c) versus palpable (cT2) prostate cancers in patients undergoing radical retropubic prostatectomy. Urology. Jul 1999;54(1):105-10.
Kaplan-Meier PSA progression (systemic/local and/or PSA level >0.2 ng/mL) survival estimates for 4453 patients with clinically localized prostate cancer treated with radical prostatectomy with or without adjuvant therapy. Numbers in parentheses represent standard error and number of patients at risk at that point. Reprinted from Ghavamian R, Blute ML, Bergstralh EJ, et al. Comparison of clinically nonpalpable prostate-specific antigen-detected (cT1c) versus palpable (cT2) prostate cancers in patients undergoing radical retropubic prostatectomy. Urology. Jul 1999;54(1):105-10.
Certain clinical and pathologic factors of c-T1c tumors closely resemble c-T2b/c tumors, especially with regard to preoperative PSA level and margin positivity. The short-term, 7-year, cause-specific survival rates of 99.9%, 98.6%, and 97.6% in clinical T1c, T2a, and T2b/c prostate cancers, respectively, in the PSA era are a testament to the effectiveness of radical prostatectomy in this group of patients, which comprises 93% of the surgically treated patients at the Mayo Clinic.
Clinical stage T3
The role of radical prostatectomy in patients with locally advanced disease is controversial. Much of the controversy is based on earlier series, which reported poor 10-year survivals in patients undergoing radical perineal prostatectomy.29,30 Note that patients in the earlier series were incompletely staged. Because of the high incidence of lymph node metastasis and the potential for incomplete excision, surgeons use monotherapy with androgen deprivation and radiotherapy.
Monotherapy with androgen deprivation therapy is associated with a 34% progression to metastatic disease and a 22% mortality rate within 2 years of therapy and should thus be reserved for elderly patients or patients with significant comorbid disease. Radiotherapy alone also yields a poor outcome, especially with regard to local control. Studies show that failure to control the primary tumor results in an increased risk of metastatic disease dissemination. Postirradiation biopsy results following definitive external-beam radiation therapy have been positive in 55-93% of patients. Five- and 10-year survival rates following external-beam radiation range from 60-72% and 41-47% respectively.
The authors' approach to radical prostatectomy in locally advanced prostate cancer is based on the principle of wide excision of the neurovascular bundles; en bloc removal of both layers of Denonvilliers fascia, the ampullae of the vas deferens, and the seminal vesicles; precise apical dissection with frozen-section analysis of the apical margins; and wide excision of the circular smooth muscle fibers of the bladder neck, again based on intraoperative frozen-section analysis.
Nerve-sparing radical prostatectomy has no role in clinical stage T3 disease. In the event of a cancerous margin, wider excision can be performed. In reviewing the Mayo Clinic experience of radical prostatectomy for clinical stage T3 disease, a prominent feature was inaccurate clinical staging. In 25% of the cases in the authors' recently reported series, prostate cancers were organ-confined pathologically (less than T2c). Only 43% of the patients with clinical T3 disease had pathologic T3 disease. The rate of lymph node metastasis was 31%. In this series of 870 patients, 43% received adjuvant hormonal therapy, 7% received adjuvant external-beam radiation therapy, and 9% received both treatments after radical prostatectomy.
Operative and perioperative morbidities were comparable with clinically localized prostate cancers. Crude survival rates at 5, 10, and 15 years were 89%, 70%, and 50%, and the cause-specific survival rates at 5, 10, and 15 years were 93%, 84%, and 74%, respectively. At 10- and 15-year follow-up, 82% and 78% of patients were free of local recurrence, respectively.
Review of the authors' contemporary radical prostatectomy series in 1107 patients treated for pathological stage T3a/b disease revealed 9-year progression-free survival rates of 93% with early adjuvant hormonal therapy (within 3 mo of radical prostatectomy), 89% with adjuvant radiation therapy, and 85% with no adjuvant therapy. A more striking advantage was evident when considering local or systemic progression-free and PSA progression-free survival rates in favor of early adjuvant hormonal therapy.
The authors' experience with c-T3 disease reveals that excellent long-term survival rates with low treatment-related morbidity can be achieved with radical prostatectomy and adjuvant therapy with pathologically confirmed locally advanced disease that are not achieved by other treatment modalities. Neoadjuvant androgen deprivation does not alter the long-term recurrence rate in men with clinical stage T3 prostate cancer.
Review of outcomes after neoadjuvant therapy
The value of neoadjuvant hormonal therapy in the treatment of clinical stage T3 prostate cancer has been debated. The benefit is generally better accepted prior to radiation treatment, but the same treatment benefit has been difficult to demonstrate in the prostatectomy series. Gomella et al (1996) demonstrated that pathologic downstaging to T2c or lower was achieved in 48% of patients with 4 months of neoadjuvant hormonal therapy.31 However, the actuarial 3-year biochemical failure rate was 75%. All patients had undergone a laparoscopic lymph node dissection prior to the neoadjuvant hormonal therapy. Question exists regarding the importance of the duration of the neoadjuvant hormonal therapy.
Gleave et al (1996) reported that PSA nadir was reached in only 22% of patients when neoadjuvant hormonal therapy was instituted 3 months in advance.32 However, 84% of patients achieved nadir PSA after 8 months of neoadjuvant hormonal therapy. The surgical margin positivity rate was only 4%. In their series of 50 patients, 68% of the cancers were organ confined and 24% were specimen confined. This should be regarded with caution because only 6 of 50 patients had clinical stage T3 tumors and 15 (30%) had well-differentiated disease. Their study, however, indicated that longer duration of neoadjuvant hormonal therapy might produce more favorable results.
Consider that, even if the rate of margin positivity is decreased with neoadjuvant hormonal therapy, no evidence exists to suggest that long-term survival will be improved. Amling et al (1997) reviewed the outcome of 72 patients with clinical T3 disease who received at least an 8-week course of neoadjuvant hormonal therapy and compared them to a matched cohort of 144 patients with clinical stage T3 disease who underwent only radical prostatectomy.33 Extracapsular extension was observed in 61% of the patients who received neoadjuvant hormonal therapy versus 81% in the untreated group (P =.002). The 5-year disease-specific survivals were 89% and 97% for the treated and untreated group, respectively, and the 5-year progression-free rate was not significantly different either (48% and 62%, respectively).
The role of adjuvant therapy in the setting of a positive margin after radical prostatectomy is controversial. Leibovich et al (2000) studied 76 patients with T2N0 disease with a single site of margin positivity who received radiation treatment.34 The most common site was the apex. These patients were compared to a cohort of 76 matched men without adjuvant radiation therapy. An overall improvement in 5-year biochemical progression-free survival rate occurred in the patients who were radiated compared to the patients who were not radiated (88% vs 59%, P =.005). Interestingly, no patient in this group had local or distant recurrence, while 16% of controls had recurrence.
Generally, as the interval to PSA recurrence increases, the likelihood of responding to radiation treatment increases substantially. Valicenti et al (1999) studied the efficacy of early adjuvant radiation treatment for T3N0 prostate cancer after radical prostatectomy.35 This was a matched comparison wherein 72 patients were optimally compared. There was an 88% reduction in the risk of PSA relapse associated with radiation therapy. The 5-year freedom from biochemical failure was 89% for patients who underwent adjuvant radiation versus 55% for those undergoing radical prostatectomy alone.
Patients who have multiple gross positive margins, especially at the bladder neck or the prostate base, have a higher likelihood of systemic disease. In a pathologic analysis of anatomic site-specific positive margins, time to PSA recurrence was significantly shorter in patients with seminal vesicle invasion, those who have more than 1 positive margin, or positive margins at the bladder neck or posterolateral surface of the prostate.36 These findings are in agreement with a study performed by Blute et al (1997).37
A positive margin at the bladder neck is usually associated with other adverse pathologic characteristics, such as high Gleason score or preoperative PSA levels and margin positivity at other sites, or it can indicate occult metastatic disease. As a single site, it is responsible for only 5% of the positive margins in the University of Miami series, and these might be the patients who can benefit from adjuvant radiation to the site. In the other diffuse scenario, the patient can benefit from early adjuvant hormonal treatment.
The authors' approach to positive seminal vesicles and lymph nodes postprostatectomy has been to administer early adjuvant hormonal therapy. Early adjuvant hormonal therapy after radical prostatectomy decreases the interval to disease progression. The difference specifically is palpable in patients with positive nodes and diploid tumors. Although the Mayo Clinic has long been a proponent in this setting, others have been skeptical of the use of hormone treatment and the advantages in this setting. The value of immediate hormonal therapy after radical prostatectomy has been demonstrated in a prospective randomized study of 98 men by Messing et al (1999).38 After a median of 7.1 years of follow-up, 7 of 47 men who received immediate hormonal therapy died, as compared to 18 of 51 men in the observation group (P =.02).
Future and Controversies
With the evolving techniques and improving knowledge of surgical anatomy, physicians can perform radical retropubic prostatectomy with great efficacy and minimal morbidity. The authors believe that surgical treatment of prostate cancer is the best viable option for patients with clinically localized disease. However, its role may be expanded to locally advanced disease when used in combination with early adjuvant androgen ablative therapy in carefully selected patients who have low comorbidities and at least a 10-year life expectancy.
In light of the improvement in surgical technique and the advent of nerve-sparing prostatectomies, most patients with prostate cancer have a high quality of life after undergoing radical prostatectomy.
Pure laparoscopic radical prostatectomy has a steep learning curve and currently constitutes less than 1% of all prostatectomies in the United States. Laparoscopy was introduced to urology in the early 1990s, with the first series of laparoscopic retropubic prostatectomy reported by Schuessler and colleagues in 1991.40 Most studies indicate longer operative time for laparoscopic retropubic prostatectomy compared with radical retropubic prostatectomy, but laparoscopic retropubic prostatectomy consistently seems to yield significantly decreased estimated blood loss and transfusion rates.
The primary author has published his experience comparing pure laparoscopic retropubic prostatectomy with radical retropubic prostatectomy performed by a single surgeon. A total of 70 patients who underwent laparoscopic retropubic prostatectomy from 2001-2002, with at least 18 months of follow-up, were compared with a matched cohort of 70 patients who underwent radical retropubic prostatectomy from 1999-2001. The baseline patient characteristics, perioperative and histologic parameters, recovery time, complications, and 18-month functional data were compared.
No significant differences were found in the preoperative characteristics. The mean operative time was 181.8 ± 18.7 minutes for radical retropubic prostatectomy and 246.4 ± 46.1 minutes for laparoscopic retropubic prostatectomy (P <.001). The mean estimated blood loss was 563.2 mL for radical retropubic prostatectomy and 275.8 mL for laparoscopic retropubic prostatectomy (P <.001). The positive-margin rates between the radical retropubic prostatectomy and laparoscopic retropubic prostatectomy groups did not significantly differ (20% and 15.7%, respectively). The mean pain score on the postoperative day 1 was 4.5 in the laparoscopic retropubic prostatectomy group and 7.8 in the radical retropubic prostatectomy group on an analog pain score of 0 to 10 (P = .02).
Full recovery was achieved at 33 ± 17 days and 45 ± 20 days in the laparoscopic retropubic prostatectomy and radical retropubic prostatectomy groups, respectively (P <.001). The total perioperative complication rates for laparoscopic retropubic prostatectomy and radical retropubic prostatectomy were comparable at 18.5% and 15.7%, respectively. The diurnal continence rate (no pads) for the laparoscopic retropubic prostatectomy and radical retropubic prostatectomy groups was 70.0%, 90.0%, and 92.8% and 71.4%, 87.6%, and 92.0% at 6, 12, and 18 months, respectively. The potency rate after bilateral neurovascular preservation with or without sildenafil for the laparoscopic retropubic prostatectomy and radical retropubic prostatectomy groups was 55.0%, 72.6%, and 79.5% and 43.0%, 58.0%, and 72.4% at 6, 12, and 18 months, respectively, with no significant differences.
The authors have concluded that laparoscopic retropubic prostatectomy is well tolerated and provides short-term oncologic and functional results that are comparable with those of radical retropubic prostatectomy.
The use of robotic technology offers many advantages over conventional laparoscopic retropubic prostatectomy, including 3-dimensional visualization, magnification, increased degrees of freedom, absence of the fulcrum effect, and robotic-wrist instrumentation. The hypothesis is that robotic-assisted laparoscopic radical prostatectomy (RALP) can successfully reduce the learning curve that even experienced surgeons face while performing laparoscopic retropubic prostatectomy. The steep learning curve for laparoscopic retropubic prostatectomy is often cited as a major impediment for the widespread implementation of laparoscopic retropubic prostatectomy. Any improvement gained by the use of robotic technology would help circumvent this issue and favor the use of a laparoscopic approach over the traditional open technique.
The primary author's learning curve for this procedure has been low due to his relatively adequate and prior experience with pure laparoscopic retropubic prostatectomy. The authors believe that the robotic technique has inherent advantages, the greatest of which may lie in the significantly decreased learning curve compared with laparoscopic retropubic prostatectomy. A laparoscopically naive surgeon may require as many as 80-100 cases before reaching the peak in the learning curve for laparoscopic retropubic prostatectomy.
The primary author's abbreviated learning curve was in regard only to perioperative parameters such as blood loss, operative time, and anastomosis time. However, the learning curve has different definitions. Just being able to complete the robotic operation quickly does not translate into proficiency and into overcoming the learning curve. Proficiency has to be defined also by the return of functional outcomes after surgery. The learning curve continues to evolve and continues well into one's experience. This has been shown with radical retropubic prostatectomy and is probably also true for RALP.
The bar for functional recover (potency and continence) after open radical retropubic prostatectomy is set very high. However, based on the primary author's experience, the robotic approach provides equivalent, if not superior, outcomes. This is in line with recent studies on potency following RALP. Tewari and colleagues reported that 82% of preoperatively potent patients younger than 60 years returned to some sexual activity and that 64% were able to achieve sexual intercourse at 6 months.41 In patients older than 60 years, 75% had some return of sexual activity and 38% reported intercourse at 6 months postoperative. Seventy-six to 95% of patients achieve full continence, defined as no pad use at 12 months following the procedure. Patel and colleagues, who have the longest period of follow-up, have reported that all patients were continent at 18 months after surgery.42
The primary author's experience in radical prostatectomy is unique. After fellowship training in Urologic Oncology, he was proficient in open radical retropubic prostatectomy. He then switched to pure laparoscopic prostatectomy and performed more than 300 procedures. Following the advent of RALP, he adopted the robotic technique and has performed more than 250 operations.
RALP follows the same steps as pure laparoscopic prostatectomy. However, the robotic approach provides unique 3-dimensional visualization. The vision magnification, 3-dimensional features, and tremor-free movements provide for a precise operation. At no time in radical prostatectomy history has the anatomy and the intricacies of the slightest surgical maneuvers in the pelvis been so readily visualized and experienced. Presently, RALP is the primary author's preferred method of performing radical prostatectomy.
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Keywords
radical retropubic prostatectomy, RRP, robotic-assisted laparoscopic radical prostatectomy, RALP, prostate cancer, prostate-specific antigen, PSA, adenocarcinoma of the prostate, perineal prostatectomy, urinary incontinence, impotence, erectile dysfunction, prostatic adenocarcinoma, prostate adenocarcinoma, radical prostatectomy, minimally invasive radical prostatectomy, robotic prostatectomy, laparoscopic radical prostatectomy
