To clarify the role of radical prostatectomy (RP) in the treatment of locally advanced and high-grade prostate cancer.
Literature search of Medline publications on surgery for locally advanced and high-grade prostate cancer.
In patients with locally advanced disease, the cancer-specific survival rate after RP at 5- and 10-yr follow-up was 85–100% and 57–91.6%, respectively. The overall survival rate at 5 and 10 yr was
It is likely that surgery has a role in the treatment of locally advanced and high-grade tumours. However, it is necessary and urgent to have randomised trials assessing survival and quality of life when RP is and is not included in the multimodality treatment.
Keywords: Gleason score, High-grade, Locally advanced, Prostate cancer, Radical prostatectomy, Survival.
Locally advanced prostate cancer is defined as cancer that has extended clinically beyond the prostatic capsule, with invasion of the pericapsular tissue, apex, bladder neck, or seminal vesicles, but without lymph node involvement or distant metastases . It is referred to as T3–T4 N0 M0 prostatic cancer. High-grade prostate cancer, also referred to as poorly differentiated prostate cancer, involves tumours with Gleason scores from 8 to 10. In the literature we often find the term high-risk cancer. Based on preoperative parameters, Yossepowitch et al used eight definitions to identify high-risk clinically localised cancer patients and concluded that these patients do not have a uniformly poor prognosis after radical prostatectomy (RP). Many patients classified as being at high risk have pathologically organ-confined cancer and may be cured by RP alone . Historically, patients with locally advanced disease and high-grade prostate cancer have not been viewed as good candidates for RP, due to the high incidence of positive pelvic lymph nodes and poor long-term survival rates  and . The advent of prostate-specific antigen (PSA) screening and modern imaging modalities allow early detection of high-grade tumours. The use of these screening techniques has led to stage migration and decreased morbidity after RP, sparking renewed interest in the use of surgery in men with advanced prostate cancer. Nevertheless, the optimal therapy for patients with locally advanced and high-grade tumours remains to be clearly defined.
2. Surgery for locally advanced and high-grade prostate cancer
Until recently, surgical treatment has not been used in clinical T3–T4 disease and high-grade prostate cancer. Over-staging (pT2), over-grading, and under-staging (pT4 or pN+) are common clinical errors. Nomograms can be useful in predicting the pathologic stage of the disease  and  and seminal vesicle invasion at RP . In addition, nodal imaging with computed tomography (CT) scans, seminal vesicle invasion (SVI) imaging with magnetic resonance imaging (MRI), or directed specific-puncture biopsies of the nodes or seminal vesicles can be helpful in recognising patients who would not benefit from a surgical approach .
The European Association of Urology (EAU) guidelines on prostate cancer state that RP can be performed in patients with locally advanced prostate cancer (PSA
Extended lymph node dissection (LND) is mainly advised in locally advanced disease and high-grade prostate cancer, due to a higher risk of node-positive disease. In older surgical series of cT3 disease, the node-positive rate is between 27% and 41% , , and . Two series had a much lower rate of pN+ cases, with only 8.5% and 11%, respectively, probably due to more accurate and dedicated CT scanning of the pelvis and methods of patient selection  and . CT scanning and fine-needle aspiration cytology increase the preoperative diagnostic accuracy of lymph node invasion . CT-guided biopsies or, when available, sentinel-guided laparoscopic lymphadenectomy can improve the preoperative lymph node assessment . Moreover, the percentage of positive biopsy cores can improve the ability to predict lymph node invasion in patients undergoing RP and extended pelvic lymph node dissection . The most common postoperative complications are urinary incontinence and sexual dysfunction, which occur immediately after RP and tend to improve over time. In early stages of the disease, the incidence of these complications can be reduced by nerve-sparing surgery. In men with T3 disease, however, non–nerve-sparing RP must be carried out . Increased overall surgical experience leads to decreased operative morbidity and better functional results  and .
3. Locally advanced prostate cancer
3.1. Studies with RP monotherapy
RP monotherapy may be an acceptable treatment option for cT3 disease. This is true not only in over-staged patients (pT2), but also in true unilateral pT3a, especially if the tumour is specimen-confined (R0). In cT3 disease, the cancer-specific survival (CSS) rate after RP at 5- and 10-yr follow-up is 85–100% and 57–72%, respectively. The overall survival rate (OS) at 5 and 10 yr of follow-up is
A retrospective multi-institutional analysis of RP monotherapy, looking at 345 patients with cT3 disease, found an actuarial 10-yr CSS rate of only 57%. For patients with well-differentiated, moderately differentiated, and poorly differentiated tumours, CSS rates at 10 yr were 73%, 67%, and 29%, respectively. These results suggest a clear role for RP in treatment of patients with low- to intermediate-grade tumours. However, in poorly differentiated tumours, RP alone appears unlikely to result in long-term survival . In a single-center series of 83 surgically treated cT3 patients, Van den Ouden et al reported that RP monotherapy produces acceptable results in men with well- or moderately differentiated tumours. In this study, the 5- and 10-yr OS rates were 75% and 60%, respectively, and the 5- and 10-yr CSS rates were 85% and 72%, respectively  and .
A study from Van Poppel et al demonstrated that RP monotherapy is an effective treatment in men with T3 disease, particularly in patients with a serum PSA value
These results support the use of RP monotherapy as a possible treatment for selected locally advanced prostate cancer. The possible occurrence of complications is not seen as a valid reason for not performing RP in cT3 disease because only two serious events were observed in a recently reported surgical feasibility study .
3.2. Multimodality treatment
In a substantial number of patients, RP monotherapy will not result in a definitive cure; therefore, early adjuvant or late salvage radiation (RT) or hormone treatment (HT) should be considered. In addition, neoadjuvant HT is a possible treatment method, although its role in clinical T3 prostate cancer remains controversial , , , , and .
In a study by Ward et al, 78% of patients eventually needed adjuvant or salvage RT or HT compared to 56% of patients in a recent study from Hsu et al. These studies reveal excellent 5-, 10-, and 15-yr OS and CSS rates, comparable to those obtained in cT2 patients. In addition, the Ward and Hsu studies had similar survival rates, with 5-yr CSS rates of 95% and 98.7%, respectively, and 10-yr CSS rates of 90% and 91.6%, respectively  and . Ward et al also reported a 15-yr CSS rate of 79%.
In a recent study by Gontero et al, RP appears to be a valid treatment with acceptable morbidity in patients with locally advanced prostate cancer of any T
In the meantime, RP series revealed survival rates that surpass those for RT alone and comparable to those of 3 yr of androgen-deprivation therapy combined with external RT (Bolla series; 5-yr OS 78%) .
Two randomised studies compared postoperative RT with RP alone for locally advanced prostate cancer. Bolla et al reported an improved biochemical progression-free survival (BPFS) in patients treated with adjuvant postoperative RT (74% vs. 52.6%, p
Our belief that RP has a place in the treatment of locally advanced prostate cancer is supported by a few studies recently conducted in the United States , , , , , and . A recent US study showed that patients who underwent RP (n
4. High-grade prostate cancer
4.1. Studies with radical prostatectomy monotherapy
A Gleason score
These results suggest that one third of patients with a biopsy Gleason score
Serni et al evaluated the outcome of 116 patients with Gleason scores
Bastian et al reviewed the data of men with Gleason scores of 8–10 treated with RP at the Johns Hopkins Hospital (n
Although most high-grade tumours extend outside the prostate, those that are confined to the prostate at histopathologic examination have a good prognosis after RP .
PSA screening enables detection of high-grade tumours with smaller volume at an earlier stage, thus improving the organ- and specimen-confined disease rates . Two separate studies reported the incidence of organ-confined disease at 26% and 31%  and . Mian et al showed that patients with organ- and specimen-confined disease had a higher 5-yr disease-free survival rate than those with non–specimen-confined disease (82%, 84%, and 50%, respectively). A favourable disease-free survival could be expected in patients treated with RP alone, especially if the cancer is confined to the prostate or surgical specimen . Bastian et al found higher 5- and 10-yr estimated BPFS among men with organ-confined disease and negative surgical margins (79% and 50% vs. 40% and 27% for the entire cohort, respectively) .
Serni et al reported that the incidence of organ-confined node-negative disease is 11.2%. At a mean follow-up of 46 mo, all patients with organ-confined disease were free of biochemical recurrence. These results emphasise the importance of early diagnosis and indicate that intracapsular tumours are less likely to metastasise, even with a high Gleason score. The incidence of pT3, specimen-confined, node-negative disease (29.3%) was greater than has been reported in other series , , , and . Serni et al reported that the 5-yr BPFS rates for pT3a specimen-confined, pT3a non–specimen-confined, and pT3b disease were 68.2%, 53.3%, and 10.5%, respectively. These results show that high-grade tumours that have invaded the capsule can also be cured by surgery. The finding of negative margins improves the BPFS, although the presence of histologically confirmed SVI indicates a poor prognosis. Using the anterograde technique minimises the incidence of positive surgical margins in high-risk patients and increases the pT3a specimen-confined detection rate .
Grossfeld et al noted a 5-yr disease-free survival rate of 47% in high-grade patients with PSA
A more recent study by Hurwitz et al assessed the surgical outcome of 168 men with high-grade prostate cancer. Patients with PSA
Interobserver variations in pathologic staging are well documented and need consideration.
4.2. Comparison among conservative treatment, RP, and RT
Recently, Tewari et al compared the use of conservative treatment (n
4.3. Multimodality treatment
To achieve complete elimination of local disease and to improve outcomes, multimodality treatment is often recommended for high-grade prostate cancer. Lau et al reported that treatment with adjuvant HT in patients with high-grade cancer appears to improve the 10-yr progression-free survival rate after RP but does not significantly reduce death from prostate cancer within 10 yr . Postoperative RT in the treatment of high-grade prostate cancer may improve outcomes, but its role remains controversial. In men with high-grade prostate cancer, Do et al reported a 5-yr BPFS of 65% in patients treated with RP and postoperative RT compared with 30% after RP alone, and 25% after RT alone. The clinical progression-free survival was also improved with the addition of postoperative RT compared with RP and RT alone (80%, 60%, and 35%) . Other reports have indicated that adjuvant RT is associated with a lower risk of biochemical recurrence, although there is no significant improvement in CSS rates at 10-yr follow-up  and . Loeb et al reviewed the data of 288 men who underwent RP, 254 of whom were high-risk patients (cT2b, a Gleason score of 8–10, PSA
Bastian et al recommend multimodality therapy for high-grade tumours. This often consists of RT plus HT; however, newer possibilities exist, such as a combination of RP plus neoadjuvant or adjuvant (chemo)-HT or RP with adjuvant RT . A recent paper reviews the use of a combination of external-beam RT and systemic agent with RP for high-risk prostate cancer patients .
It is very likely that RP is an effective form of treatment for locally advanced and high-grade tumours. The best candidates for RP are patients who were clinically over-staged or over-graded by the puncture biopsy and whose tumours were subsequently found to be locally confined, to have limited extracapsular extension, or to be moderately differentiated. However, this does not mean that more advanced stages or grades are necessarily a contraindication for surgery. In younger patients, even advanced tumours and Gleason scores
Urologists must use the pathologic results, which indicate the need for additional postoperative treatment, to improve the final outcome. Further studies will be required to clarify whether neoadjuvant (chemo)-HT, adjuvant/salvage (chemo)-HT, and adjuvant/salvage RT can improve the results of RP.
5.1. Locally advanced prostate cancer
RP monotherapy provides tumour control in selected patients with cT3 disease, with 5- and 10-yr CSS rates of
In well-selected patients, RP, combined with adjuvant or salvage treatment when needed, may result in better outcomes than RT alone, similar to the combination of RT plus HT therapy. These findings should be confirmed in randomised, prospective studies.
5.2. High-grade prostate cancer
In a recent study, patients with high-grade prostate cancer who underwent RP monotherapy had 5- and 10-yr BPFS rates of 51% and 39%, respectively. This is in agreement with rates reported in other series. Studies show that up to one third of patients with high-grade prostate cancer are subsequently downgraded and have a better BPFS probability after RP. Disease-free survival after RP can also be expected if the cancer is confined to the prostate or surgical specimen. PSA value and the % PBCs can be useful in selecting men with high-grade prostate cancer most likely to benefit from RP. Patients with high-grade prostate cancer are likely to be good candidates for multimodality treatment, often consisting of RP with adjuvant or salvage RT and HT, although newer treatment combinations are being tested.
Conflicts of interest
The authors have nothing to disclose.
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Department of Urology, University Hospital, K.U. Leuven, Leuven, Belgium
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