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Single tertiary cancer center experience on the management of pT3b prostate cancer after robotic-assisted laparoscopic prostatectomy

Single tertiary cancer center experience on the management of pT3b prostate cancer after... Background: Pathological involvement of the seminal vesicle poses a treatment dilemma following robotic prostatectomy. Margin sta- tus plays an important role in deciding further management. A wide range of treatment options are available, including active monitoring, adjuvant radiotherapy, salvage radiotherapy, and occasionally androgen deprivation therapy. Patients undergoing postoperative radio- therapy tend to have higher risk of urinary and bowel morbidities. The recent RADICALS-RT concluded that adjuvant radiotherapy did not have any benefit compared with salvage radiotherapy. We aim to audit the incidence, margin status, and management of T3b cancer cases at our center. Materials and methods: A retrospective analysis was conducted of all patients diagnosed with pathological T3b (pT3b) prostate can- cer following robotic-assisted laparoscopic prostatectomy from January 2012 to July 2020. Preoperative parameters analyzed included prostate-specific antigen (PSA), T stage, and age. A chi-square test and 2-tailed t test were used to determine the relationship between categorical and continuous variables, respectively. Kaplan-Meier survival curves were generated to assess overall survival in patients with pT3b prostate cancer and used to compare unadjusted progression-free survival among those who underwent adjuvant and sal- vage radiotherapy. Results: A total of 83 (5%) of 1665 patients who underwent robotic prostatectomy were diagnosed with pT3b prostate cancer between January 2012 and July 2020. Among these, 36 patients (44%) did not receive any radiotherapy during follow-up, compared with 26 patients (31%) who received adjuvant radiotherapy and 21 (25%) who received salvage radiotherapy. The median age of our cohort was 64 (SD, 6.4) years. Mean PSA at presentation was 12.7 μg/L. Positive margins were seen in 36 patients (43%); however, there was no statistically significant difference between treatment groups (p = 0.49). The median overall survival was 96%. There was no signif- icant difference between the adjuvant and salvage groups in terms of biochemical progression-free survival (p = 0.66). Five-year biochem- ical progression-free survival was 94% for those in the adjuvant radiotherapy group and 97% for those in the salvage radiotherapy group. Conclusions: Our audit corroborates with the recently concluded RADICALS-RT study, although we had fewer patients with positive margins. Radiotherapy can be avoided in patients with T3b prostate cancer, even if margin is positive, until there is definitive evidence of PSA recurrence. In keeping with the conclusion of RADICALS-RT, salvage radiotherapy may be preferable to adjuvant radiotherapy. Keywords: Prostate cancer; Radiotherapy; Robotic prostatectomy; Seminal vesicle; T3b 1. Introduction pre-treatment. The sensitivity of MRI to diagnose seminal vesicle [1] Clinically localized prostate cancer can be treated successfully with (SV) invasion T3b prostate cancer is in the range of 60%, [2] a robotic radical prostatectomy (RP). Clinical diagnosis is cur- whereas the specificity is 95%. The incidence of T3b prostate [3,4] rently based on prostate-specific antigen (PSA), digital rectal exam- cancer reported on MRI is approximately 10%, as compared ination, and now with multiparametric magnetic resonance imag- with 5% to 18% of patients having SV invasion on pathologic ex- [5–11] ing (mpMRI) followed by prostate biopsy. A prebiopsy prostate amination after RP. MRI is now used as an accurate modality to stage prostate cancer The invasion of the SV (T3b disease) is usually associated with adverse clinical outcomes in patients with prostate cancer and is believed to be associated with occult micrometastatic disease, ear- *Corresponding Author: Arvind Nayak, Department of Urology, Lister Hospital, [5] Stevenage, SG1 4AB, UK. E-mail address: arvindnayakk@gmail.com. lier biochemical relapse, and progression of disease. Biochemical Current Urology, (2022) 16, 4, 227–231 recurrence was reported to be approximately 60% in a previous [6] Received October 30, 2021; Accepted December 16, 2021. analysis of 300 men with SV invasion. http://dx.doi.org/10.1097/CU9.0000000000000115 A wide range of treatment options are available, including active Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. This is monitoring, adjuvant radiotherapy (RT), salvage RT, and occa- an open-access article distributed under the terms of the Creative Commons sionally androgen deprivation therapy (ADT). The standard of Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it care for patients with SV invasion has traditionally been RT com- is permissible to download and share the work provided it is properly cited. [7,8] bined with2to 3 years ofADT. The treatment for high-risk The work cannot be changed in any way or used commercially without permission from the journal. prostate cancer (HRPCa) is not yet standardized because of the 227 Nayak et al.  Volume 16  Issue 4  2022 www.currurol.org lack of evidence to prove the superiority of a single option with re- 2. Materials and methods gard to oncological outcomes. Therefore, the choice of treatment is The Lister Hospital database (2012 to present) was queried for currently guided by individual scenarios, concerns for adverse ef- men with pT3b disease. A retrospective analysis was conducted fects, and impact on quality of life (QOL) for the patient. of all patients diagnosed with pT3b prostate cancer following Various researchers have investigated the toxicities and impact robotic-assisted laparoscopic prostatectomy from January 2012 on QOL of different management options for prostate cancer, to July 2020. Seminal vesicle invasion was defined as tumor invad- whereas some have also compared baseline patient profiles with ing the muscular wall of the SV, which can occur by extraprostatic posttreatment QOL to definitively implicate treatment toxicities. extension at the base of the prostate, direct tracking along the ejac- Patients undergoing postoperative RT tend to have higher risk of [14] ulatory duct complex, or via isolated, noncontiguous SV deposits. urinary and bowel morbidities. Preoperative parameters analyzed included PSA, T stage, and age. Interestingly, most of these articles have focused on localized dis- Postoperative margin status and pathological stage were exam- ease, where single-modality treatment is optimal, and the need for ined. Patients were categorized based on margin status and RT multimodal therapy is unusual. Therefore, RP alone is compared treatment plan accordingly (no RT, adjuvant RT, and salvage RT). with brachytherapy alone and/or external beam RT alone. On Demographic and pathologic data were compared between pa- the contrary, in the case of HRPCa, most international guidelines tients who had T3b prostate cancer and underwent salvage, adju- recommend multimodal management. There exists a compelling vant, and no RT. A chi-square test and 2-tailed t test were used need for evidence with regard to toxicities and impact on QOL in to determine the relationship between categorical and continuous this subset of patients. variables, respectively. Kaplan-Meier survival curves were gener- Randomized trials from the 1980s, European Organisation for ated to assess overall survival in patients with pT3b prostate cancer Research and Treatment of Cancer (EORTC) and the Radiation and used to compare the unadjusted progression-free survival be- [7] Therapy Oncology Group, compared combined long-term ADT tween those who underwent adjuvant and salvage RT. Biochemi- and RT treatment of HRPCa with RT alone, concentrating on cal failure was defined as a PSA of >0.4 μg/L. All statistical tests physician-reported classic toxicities and oncological outcomes. They were 2-sided by default, and the significance level was set at 0.05, found combination therapy to be superior in terms of survival, with unadjusted for multiple comparisons. All statistical analyses were no significant differences with regard to genitourinary and gastroin- conducted using Prism 6 (GraphPad Software, Inc, San Diego, CA). testinal toxicities. However, effects on sexual QOL were not ana- lyzed. Recent randomized controlled trials have reconfirmed these [9] findings, but data on QOL impact are absent in these studies also. 3. Results [10] Case series from Centers of Surgical Excellence have found that 75% to 80% of patients who underwent initial RP for treatment of A total of 83 subjects were identified with T3b prostate adenocarci- HRPCa needed either early adjuvant RT and/or ADT or late sal- noma, with a median follow-up of 36 months (Table 1). Thirty-six pa- vage therapy. Hence, it is imperative to counsel patients with tients (44%) did not receive any RT during follow-up, 26 patients HRPCa initially about the need for multimodal therapy and the (31%) received adjuvant RT, and 21 patients (25%) received salvage risks associated with each modality. Randomized controlled trials RT. The median age of our cohort was 64 (SD, 6.4) years, with no sta- comparing immediate postoperative RT with observation have tistically significant difference between the groups (p=0.34).MeanPSA shown no increased risk of genitourinary or gastrointestinal toxic- at presentation was 12.7 μg/L, with no statistically significant difference [11] ities. But monoinstitutional series have suggested a delayed time between groups (p = 0.26). Among all patients, 38 (46%) had a Gleason to continence recovery associated with RT following both nerve-sparing score of 3 + 4, which was the most common pathological pattern. How- [12] and non-nerve-sparing RP. ever, there was a lower proportion of patients (12%) who had a [13] The recent RADICALS-RT concluded that adjuvant RT did Gleason score of >8 who received adjuvant RT when compared with not have any benefits compared with salvage RT. In this study, those not receiving RT (25%) or those receiving salvage RT (33%). Pos- we aim to audit the incidence, margin status, and management of itive margins were seen in 36 patients (43%); however, there was no sta- T3b cancer cases at our center. tistically significant difference between treatment groups (p =0.49). Table 1 Baseline characteristics. Characteristics No radiotherapy (n = 36) Adjuvant radiotherapy (n = 26) Salvage radiotherapy (n = 21) Age (range), yr 63 (55–74) 62 (46–72) 60 (51–72) Mean PSA at presentation, mean (SD), μg/L 11.4 (6.2) 14.4 (8.2) 13.1 (7.1) Gleason score, n (%) <7 0(0) 1(4) 0 (0) 3+4 16(44) 14 (54) 8 (38) 4 + 3 11 (31) 8 (31) 6 (29) >8 9 (25) 3 (12) 7 (33) Positive margin, n (%) Absent 23 (64) 13 (50) 11 (52) Present 13 (36) 13 (50) 10 (48) Lymph nodes, n (%) Node positive 1 (3) 1 (4) 1 (5) Node negative 11 (31) 10 (38) 13 (62) No dissection 24 (67) 15 (58) 7 (33) PSA = prostate-specific antigen. 228 Nayak et al.  Volume 16  Issue 4  2022 www.currurol.org Figure 1. Kaplan-Meier curve showing overall survival of patients with pT3b adenocarcinoma of the prostate. OS = overall survival. [18] Unadjusted Kaplan-Meier estimates for overall survival were on therapeutic planning. The use of mpMRI has also played an im- generated for patients with pT3b prostate adenocarcinoma, with portant role in selection of candidates for nerve-sparing and pelvic a median overall survival of 96% (p = 0, Fig. 1). Three patients lymph node dissection. Recent studies have suggested that 43% of pa- [19] died, of whom only one death was attributed to prostate cancer. tients with pathological T3b have involved pelvic lymph nodes. Twenty-four patients (51%) who had negative margins underwent Management of patients with pathological T3b can vary from RT (13 [28%] in the adjuvant group and 11 [23%] in the salvage surveillance, to adjuvant and salvage RT and ADT. The presence group), whereas the remaining 23 patients (49%) did not receive of a positive margin has a bearing on the most appropriate treat- any RT treatment (Fig. 2). There was no statistically significant differ- ment offered to the patient. Favorable oncological outcomes with- ence between patients with negative margins who underwent RT (ad- out adjuvant treatment have been observed in patients with a neg- juvant or salvage) compared with no RT (p = 0.84). Twenty-three pa- ative surgical margin and PSA <0.2 μg/L at 1 month following [20] tients (64%) with a positive surgical margin underwent RT (13 [35%] prostatectomy ; however, long-term outcomes are still unclear. in the adjuvant group and 10 [28%] in the salvage group); the remain- Hence, subjecting all patients to RT may lead to overtreatment. ing 23 patients (36%) did not receive any RT treatment (Fig. 3). Pa- Several studies have been designed to help determine the timing [21] tients with a positive margin favored RT (p =0.03).There wasno sta- of RT following prostatectomy. The EORTC 22911 and [22] tistically significant difference between patients undergoing adjuvant Southwest Oncology Group 8794 essentially compared adju- versus salvage RT (p =0.8). vant RT to observation, as not all patients received salvage RT Regarding outcome measures, 8 biochemical progression events were for biochemical progression. Although the Southwest Oncology reported: 5 in the adjuvant RT group and 3 in the salvage RT group over Group trial was the only trial to show a survival benefit for patients an 8-year period (Fig. 4). No difference was found between the adjuvant who received adjuvant RT, it could be attributed to the late use of and salvage groups in terms of biochemical progression-free sur- salvage RT. The EORTC 22911 trial did show a bPFS benefit but vival (bPFS) (p = 0.66). Five-year bPFS was 94% for those in the no overall survival benefit in patients who received adjuvant RT. [23] adjuvant RT group and 97% for those in the salvage RT group. ARO 96-02 trial and the Finnish Radiation Oncology Group [10] trial were smaller trials, with a total of 557 patients, designed to answer the question of salvage versus adjuvant RT. Both tri- 4. Discussion als demonstrated that adjuvant RT reduced the risk of biochem- ical progression. Although these studies demonstrated the benefit Approximately 5% to 18% of patients tend to have pathological in- of adjuvant RT, they did not enlighten us on the optimal timing [6,15–17] volvement of SV following RP. The use of mpMRI has led to of RT. more accurate preoperative staging and has made a significant impact Figure 2. Patients with negative margins receiving adjuvant, salvage, or no radiotherapy. Figure 3. Patients with a positive margin receiving adjuvant, salvage, or no radiotherapy. 229 Nayak et al.  Volume 16  Issue 4  2022 www.currurol.org Figure 4. Kaplan-Meier curve demonstrating biochemical progression-free survival in the adjuvant and salvage radiotherapy groups. The largest randomized controlled trial (n = 1396) to date com- with an initial greater burden of comorbidities. These consider- paring routine adjuvant RT after RP with salvage RT for PSA bio- ations need to be borne in mind when customizing treatment plans [24] chemical progression, RADICALS-RT, showed no benefit with for patients. There is an urgent need to stratify HRPCa patients, to adjuvant RT; however, it did demonstrate an increased risk of uri- better adapt the duration of ADT based on the characteristics of nary and bowel morbidities. Thus, the authors recommended PSA their disease and comorbidities. surveillance as opposed to adjuvant RT. In that study population, Our study has a few limitations, including the retrospective na- 19% of patients had T3b disease, and 63% had positive margins, ture of the study. In addition, some of the patients with T3b disease and subgroup analysis showed no difference in outcomes com- had been recruited in the recently concluded RADICALS-RT study. pared with the rest of the study population. A French multicenter (46 hospitals) open-label, phase 3 trial, [25] 5. Conclusions GETUG-AFU 17, randomized 424 patients to adjuvant or sal- vage RT. They found an increased risk of genitourinary toxicity Our audit corroborates with the recently concluded RADICALS-RT and erectile dysfunction with no oncological benefit in patients re- study, although we had fewer patients with positive margins. Ra- ceiving adjuvant RT versus salvage RT. diotherapy can be avoided in patients with T3b prostate cancer, Another multicenter randomized trial of 333 patients across 32 even if margins are positive, until there is definitive evidence of oncology centers in Australia and New Zealand, TROG 08.03/ PSA recurrence. In keeping with the conclusion of RADICALS-RT, [24] ANZUP RAVES, concluded that biochemical control was sim- salvage RT appears preferable to adjuvant RT. ilar between salvage RT and adjuvant RT; however, salvage RT spared approximately half of men from pelvic radiation, resulting Acknowledgments in significantly lower genitourinary toxicity. [26] None. A prospective systematic review and meta-analysis, ARTISTIC, suggested that adjuvant RT does not improve event-free survival in Statement of ethics men with localized or locally advanced prostate cancer. Until data on long-term outcomes are available, current evidence suggests that According to local institutinal regulations, we confirm that ethical early salvage treatment would reduce the need for pelvic RT in half approval and participants' consent were not required as ethical ap- of the men, therefore reducing associated genitourinary toxicity. proval is not warranted in a retrospective observational study. All Lymph node positivity in patients with T3b prostate cancer is an procedures performed in this study involving human participants important factor that can influence management, as patients with were in accordance with the ethical standards of the institutional positive lymph nodes may go on to have adjuvant chemotherapy and national research committee and with the 1964 Helsinki Decla- or RT. Studies have shown that 11% to 24% of patients with ration and its later amendments or comparable ethical standards. [11,27] T3b disease have positive pathological lymph nodes. The 5-year bPFS in patients with T3b prostate cancer has been Conflict of interest statement [28] found to be extremely variable, ranging from 8% to 68%. Bio- No conflict of interest has been declared by the authors. chemical progression-free survival rates are dependent on variabil- [29–31] ity in PSA level, margin status, and Gleason score. In our se- Funding source ries, 5-year bPFS was 94% in the adjuvant RT group and 97% in the salvage RT group. None. Patients with HRPCa represent a highly heterogeneous group. Most patients will require both RT and long-term ADT. A selected Author contributions subgroup of patients (those with limited local burden of disease, cT3a or initial cT3b, a Gleason score of 7, and PSA <20 ng/mL, AN: Data collection and draft of manuscript; for example) may benefit from a dose escalation into the prostate OET: Statistical analysis; with short-term (6 months) ADT, thus reducing the likelihood of NV: Conceived the study; combined adverse effects. Recent data have shown a possibility SS, JP, AG, RG, RA, PO, AS, TL, JA: Literature review and review of cardiac deaths with long-term ADT, particularly for patients of manuscript. 230 Nayak et al.  Volume 16  Issue 4  2022 www.currurol.org References after radical prostatectomy for patients with seminal vesicle invasion and negative lymph nodes. Urol Oncol 2014;32(1):26.e1–26.e7. [1] Edge SB, Compton CC. The American Joint Committee on Cancer: The 7th [18] Mottet N, Bellmunt J, Bolla M, et al. EAU-ESTRO-SIOG guidelines on edition of the AJCC cancer staging manual and the future of TNM. Ann prostate cancer. Part 1: Screening, diagnosis, and local treatment with Surg Oncol 2010;17(6):1471–1474. curative intent. Eur Urol 2017;71(4):618–629. [2] Goupy F, Supiot S, Pasquier D, et al. Intensity-modulated radiotherapy for [19] Poelaert F, Joniau S, Roumeguère T, et al. Current management of pT3b prostate cancer with seminal vesicle involvement (T3b): A multicentric prostate cancer after robot-assisted laparoscopic prostatectomy. Eur Urol retrospective analysis. PLoS One 2019;14(1):e0210514. Oncol 2019;2(1):110–117. [3] Cornud F, Flam T, Chauveinc L, et al. Extraprostatic spread of clinically localized [20] Tosco L, Laenen A, Briganti A, et al. The EMPaCT classifier: A validated prostate cancer: Factors predictive of pT3 tumor and of positive endorectal MR tool to predict postoperative prostate cancer-related death using competing-risk imaging examination results. Radiology 2002;224(1):203–210. analysis. Eur Urol Focus 2018;4(3):369–375. [4] Brajtbord JS, Lavery HJ, Nabizada-Pace F, Senaratne P, Samadi DB. [21] Bolla M, Van Poppel H, Tombal B, et al. Postoperative radiotherapy after Endorectal magnetic resonance imaging has limited clinical ability to radical prostatectomy for high-risk prostate cancer: Long-term results of a preoperatively predict pT3 prostate cancer. BJU Int 2011;107(9): randomised controlled trial (EORTC trial 22911). Lancet 2012;380 1419–1424. (9858):2018–2027. [5] Bloom KD, Richie JP, Schultz D, Renshaw A, Saegaert T, D’Amico AV. [22] Swanson GP, Goldman B, Tangen CM, et al. The prognostic impact of Invasion of seminal vesicles by adenocarcinoma of the prostate: PSA seminal vesicle involvement found at prostatectomy and the effects of outcome determined by preoperative and postoperative factors. Urology adjuvant radiation: Data from Southwest Oncology Group 8794. JUrol 2004;63(2):333–336. 2008;180(6):2453–2458. [6] Secin FP, Bianco FJ, Vickers AJ, et al. Cancer-specific survival and [23] Wiegel T, Bartkowiak D, Bottke D, et al. Adjuvant radiotherapy versus predictors of prostate-specific antigen recurrence and survival in patients wait-and-see after radical prostatectomy: 10-year follow-up of the ARO with seminal vesicle invasion after radical prostatectomy. Cancer 2006; 96-02/AUO AP 09/95 trial. Eur Urol 2014;66(2):243–250. 106(11):2369–2375. [24] Kneebone A, Fraser-Browne C, Duchesne GM, et al. Adjuvant radiotherapy [7] Hanks GE, Pajak TF, Porter A, et al. Phase III trial of long-term adjuvant versus early salvage radiotherapy following radical prostatectomy (TROG androgen deprivation after neoadjuvant hormonal cytoreduction and 08.03/ANZUP RAVES): A randomised, controlled, phase 3, non-inferiority radiotherapy in locally advanced carcinoma of the prostate: The Radiation trial. Lancet Oncol 2020;21(10):1331–1340. Therapy Oncology Group Protocol 92-02. JClin Oncol 2003;21(21): [25] Sargos P, Chabaud S, Latorzeff I, et al. Adjuvant radiotherapy versus early 3972–3978. salvage radiotherapy plus short-term androgen deprivation therapy in men [8] Bolla M, de Reijke TM, Van Tienhoven G, et al. Duration of androgen with localised prostate cancer after radical prostatectomy (GETUG-AFU suppression in the treatment of prostate cancer. NEngl J Med 2009;360 17): A randomised, phase 3 trial. Lancet Oncol 2020;21(10):1341–1352. (24):2516–2527. [26] Vale CL, Fisher D, Kneebone A, et al. Adjuvant or early salvage [9] Widmark A, Klepp O, Solberg A, et al. Endocrine treatment, with or without radiotherapy for the treatment of localised and locally advanced prostate radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): An cancer: A prospectively planned systematic review and meta-analysis of open randomised phase III trial. Lancet 2009;373(9660):301–308. aggregate data. Lancet 2020;396(10260):1422–1431. [10] Milonas D, Smailyte G, Jievaltas M. Oncologic outcomes of surgery in T3 [27] Gilliland N, Vennam S, Geraghty R, et al. Surgery for pathological T3a, T3b and prostate cancer: Experience of a single tertiary center. Adv Urol 2012; lymph node positive, prostate cancer: Surgical, functional and oncological 2012:164263. outcomes. J Clin Urol September 2020. doi:10.1177/2051415820958207. [11] Hackman G, Taari K, Tammela TL, et al. Randomised trial of adjuvant radiotherapy following radical prostatectomy versus radical prostatectomy [28] Kim JK, Lee HJ, Hwang SI, Choe G, Hong SK. Prognostic value of alone in prostate cancer patients with positive margins or extracapsular seminal vesicle invasion on preoperative multi-parametric magnetic extension. Eur Urol 2019;76(5):586–595. resonance imaging in pathological stage T3b prostate cancer. Sci Rep [12] Abdollah F, Karnes RJ, Suardi N, et al. Impact of adjuvant radiotherapy on 2020;10(1):1–7. survival of patients with node-positive prostate cancer. JClinOncol 2014; [29] de Rooij M, Hamoen EHJ, Witjes JA, Barentsz JO, Rovers MM. Accuracy 32(35):3939–3947. of magnetic resonance imaging for local staging of prostate cancer: A [13] Parker CC, Clarke NW, Cook AD, et al. Timing of radiotherapy after diagnostic meta-analysis. Eur Urol 2016;70(2):233–245. radical prostatectomy (RADICALS-RT): A randomised, controlled phase [30] Cornford P, Bellmunt J, Bolla M, et al. EAU-ESTRO-SIOG guidelines on 3trial. Lancet 2020;396(10260):1413–1421. prostate cancer. Part II: Treatment of relapsing, metastatic, and castration-resistant [14] Billis A, Teixeira DA, Stelini RF, Quintal MM, Guimarães MS, Ferreira U. prostate cancer. Eur Urol 2017;71(4):630–642. Seminal vesicle invasion in radical prostatectomies: Which is the most [31] Martini A, Gupta A, Cumarasamy S, et al. Novel nomogram for the common route of invasion? Int Urol Nephrol 2007;39(4):1097–1102. prediction of seminal vesicle invasion including multiparametric magnetic [15] Pierorazio PM, Ross AE, Schaeffer EM, et al. A contemporary analysis of resonance imaging. Int J Urol 2019;26(4):458–464. outcomes of adenocarcinoma of the prostate with seminal vesicle invasion (pT3b) after radical prostatectomy. JUrol 2011;185(5):1691–1697. [16] Siddiqui SA, Boorjian SA, Blute ML, et al. Impact of adjuvant androgen How to cite this article: Nayak A, El-Taji O, Sukumar S, Piedad J, Ghose A, deprivation therapy after radical prostatectomy on the survival of patients Hughes R, Alonzi R, Ostler P, Sharma A, Lane T, Adshead J, Vasdev N. with pathological T3b prostate cancer. BJU Int 2011;107(3):383–388. Single tertiary cancer center experience on themanagement of pT3b prostate [17] Mikel Hubanks J, Boorjian SA, Frank I, et al. The presence of extracapsular cancer after robotic-assisted laparoscopic prostatectomy. Curr Urol extension is associated with an increased risk of death from prostate cancer 2022;16(4):227–231. doi: 10.1097/CU9.0000000000000115 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Current Urology Wolters Kluwer Health

Single tertiary cancer center experience on the management of pT3b prostate cancer after robotic-assisted laparoscopic prostatectomy

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Abstract

Background: Pathological involvement of the seminal vesicle poses a treatment dilemma following robotic prostatectomy. Margin sta- tus plays an important role in deciding further management. A wide range of treatment options are available, including active monitoring, adjuvant radiotherapy, salvage radiotherapy, and occasionally androgen deprivation therapy. Patients undergoing postoperative radio- therapy tend to have higher risk of urinary and bowel morbidities. The recent RADICALS-RT concluded that adjuvant radiotherapy did not have any benefit compared with salvage radiotherapy. We aim to audit the incidence, margin status, and management of T3b cancer cases at our center. Materials and methods: A retrospective analysis was conducted of all patients diagnosed with pathological T3b (pT3b) prostate can- cer following robotic-assisted laparoscopic prostatectomy from January 2012 to July 2020. Preoperative parameters analyzed included prostate-specific antigen (PSA), T stage, and age. A chi-square test and 2-tailed t test were used to determine the relationship between categorical and continuous variables, respectively. Kaplan-Meier survival curves were generated to assess overall survival in patients with pT3b prostate cancer and used to compare unadjusted progression-free survival among those who underwent adjuvant and sal- vage radiotherapy. Results: A total of 83 (5%) of 1665 patients who underwent robotic prostatectomy were diagnosed with pT3b prostate cancer between January 2012 and July 2020. Among these, 36 patients (44%) did not receive any radiotherapy during follow-up, compared with 26 patients (31%) who received adjuvant radiotherapy and 21 (25%) who received salvage radiotherapy. The median age of our cohort was 64 (SD, 6.4) years. Mean PSA at presentation was 12.7 μg/L. Positive margins were seen in 36 patients (43%); however, there was no statistically significant difference between treatment groups (p = 0.49). The median overall survival was 96%. There was no signif- icant difference between the adjuvant and salvage groups in terms of biochemical progression-free survival (p = 0.66). Five-year biochem- ical progression-free survival was 94% for those in the adjuvant radiotherapy group and 97% for those in the salvage radiotherapy group. Conclusions: Our audit corroborates with the recently concluded RADICALS-RT study, although we had fewer patients with positive margins. Radiotherapy can be avoided in patients with T3b prostate cancer, even if margin is positive, until there is definitive evidence of PSA recurrence. In keeping with the conclusion of RADICALS-RT, salvage radiotherapy may be preferable to adjuvant radiotherapy. Keywords: Prostate cancer; Radiotherapy; Robotic prostatectomy; Seminal vesicle; T3b 1. Introduction pre-treatment. The sensitivity of MRI to diagnose seminal vesicle [1] Clinically localized prostate cancer can be treated successfully with (SV) invasion T3b prostate cancer is in the range of 60%, [2] a robotic radical prostatectomy (RP). Clinical diagnosis is cur- whereas the specificity is 95%. The incidence of T3b prostate [3,4] rently based on prostate-specific antigen (PSA), digital rectal exam- cancer reported on MRI is approximately 10%, as compared ination, and now with multiparametric magnetic resonance imag- with 5% to 18% of patients having SV invasion on pathologic ex- [5–11] ing (mpMRI) followed by prostate biopsy. A prebiopsy prostate amination after RP. MRI is now used as an accurate modality to stage prostate cancer The invasion of the SV (T3b disease) is usually associated with adverse clinical outcomes in patients with prostate cancer and is believed to be associated with occult micrometastatic disease, ear- *Corresponding Author: Arvind Nayak, Department of Urology, Lister Hospital, [5] Stevenage, SG1 4AB, UK. E-mail address: arvindnayakk@gmail.com. lier biochemical relapse, and progression of disease. Biochemical Current Urology, (2022) 16, 4, 227–231 recurrence was reported to be approximately 60% in a previous [6] Received October 30, 2021; Accepted December 16, 2021. analysis of 300 men with SV invasion. http://dx.doi.org/10.1097/CU9.0000000000000115 A wide range of treatment options are available, including active Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. This is monitoring, adjuvant radiotherapy (RT), salvage RT, and occa- an open-access article distributed under the terms of the Creative Commons sionally androgen deprivation therapy (ADT). The standard of Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it care for patients with SV invasion has traditionally been RT com- is permissible to download and share the work provided it is properly cited. [7,8] bined with2to 3 years ofADT. The treatment for high-risk The work cannot be changed in any way or used commercially without permission from the journal. prostate cancer (HRPCa) is not yet standardized because of the 227 Nayak et al.  Volume 16  Issue 4  2022 www.currurol.org lack of evidence to prove the superiority of a single option with re- 2. Materials and methods gard to oncological outcomes. Therefore, the choice of treatment is The Lister Hospital database (2012 to present) was queried for currently guided by individual scenarios, concerns for adverse ef- men with pT3b disease. A retrospective analysis was conducted fects, and impact on quality of life (QOL) for the patient. of all patients diagnosed with pT3b prostate cancer following Various researchers have investigated the toxicities and impact robotic-assisted laparoscopic prostatectomy from January 2012 on QOL of different management options for prostate cancer, to July 2020. Seminal vesicle invasion was defined as tumor invad- whereas some have also compared baseline patient profiles with ing the muscular wall of the SV, which can occur by extraprostatic posttreatment QOL to definitively implicate treatment toxicities. extension at the base of the prostate, direct tracking along the ejac- Patients undergoing postoperative RT tend to have higher risk of [14] ulatory duct complex, or via isolated, noncontiguous SV deposits. urinary and bowel morbidities. Preoperative parameters analyzed included PSA, T stage, and age. Interestingly, most of these articles have focused on localized dis- Postoperative margin status and pathological stage were exam- ease, where single-modality treatment is optimal, and the need for ined. Patients were categorized based on margin status and RT multimodal therapy is unusual. Therefore, RP alone is compared treatment plan accordingly (no RT, adjuvant RT, and salvage RT). with brachytherapy alone and/or external beam RT alone. On Demographic and pathologic data were compared between pa- the contrary, in the case of HRPCa, most international guidelines tients who had T3b prostate cancer and underwent salvage, adju- recommend multimodal management. There exists a compelling vant, and no RT. A chi-square test and 2-tailed t test were used need for evidence with regard to toxicities and impact on QOL in to determine the relationship between categorical and continuous this subset of patients. variables, respectively. Kaplan-Meier survival curves were gener- Randomized trials from the 1980s, European Organisation for ated to assess overall survival in patients with pT3b prostate cancer Research and Treatment of Cancer (EORTC) and the Radiation and used to compare the unadjusted progression-free survival be- [7] Therapy Oncology Group, compared combined long-term ADT tween those who underwent adjuvant and salvage RT. Biochemi- and RT treatment of HRPCa with RT alone, concentrating on cal failure was defined as a PSA of >0.4 μg/L. All statistical tests physician-reported classic toxicities and oncological outcomes. They were 2-sided by default, and the significance level was set at 0.05, found combination therapy to be superior in terms of survival, with unadjusted for multiple comparisons. All statistical analyses were no significant differences with regard to genitourinary and gastroin- conducted using Prism 6 (GraphPad Software, Inc, San Diego, CA). testinal toxicities. However, effects on sexual QOL were not ana- lyzed. Recent randomized controlled trials have reconfirmed these [9] findings, but data on QOL impact are absent in these studies also. 3. Results [10] Case series from Centers of Surgical Excellence have found that 75% to 80% of patients who underwent initial RP for treatment of A total of 83 subjects were identified with T3b prostate adenocarci- HRPCa needed either early adjuvant RT and/or ADT or late sal- noma, with a median follow-up of 36 months (Table 1). Thirty-six pa- vage therapy. Hence, it is imperative to counsel patients with tients (44%) did not receive any RT during follow-up, 26 patients HRPCa initially about the need for multimodal therapy and the (31%) received adjuvant RT, and 21 patients (25%) received salvage risks associated with each modality. Randomized controlled trials RT. The median age of our cohort was 64 (SD, 6.4) years, with no sta- comparing immediate postoperative RT with observation have tistically significant difference between the groups (p=0.34).MeanPSA shown no increased risk of genitourinary or gastrointestinal toxic- at presentation was 12.7 μg/L, with no statistically significant difference [11] ities. But monoinstitutional series have suggested a delayed time between groups (p = 0.26). Among all patients, 38 (46%) had a Gleason to continence recovery associated with RT following both nerve-sparing score of 3 + 4, which was the most common pathological pattern. How- [12] and non-nerve-sparing RP. ever, there was a lower proportion of patients (12%) who had a [13] The recent RADICALS-RT concluded that adjuvant RT did Gleason score of >8 who received adjuvant RT when compared with not have any benefits compared with salvage RT. In this study, those not receiving RT (25%) or those receiving salvage RT (33%). Pos- we aim to audit the incidence, margin status, and management of itive margins were seen in 36 patients (43%); however, there was no sta- T3b cancer cases at our center. tistically significant difference between treatment groups (p =0.49). Table 1 Baseline characteristics. Characteristics No radiotherapy (n = 36) Adjuvant radiotherapy (n = 26) Salvage radiotherapy (n = 21) Age (range), yr 63 (55–74) 62 (46–72) 60 (51–72) Mean PSA at presentation, mean (SD), μg/L 11.4 (6.2) 14.4 (8.2) 13.1 (7.1) Gleason score, n (%) <7 0(0) 1(4) 0 (0) 3+4 16(44) 14 (54) 8 (38) 4 + 3 11 (31) 8 (31) 6 (29) >8 9 (25) 3 (12) 7 (33) Positive margin, n (%) Absent 23 (64) 13 (50) 11 (52) Present 13 (36) 13 (50) 10 (48) Lymph nodes, n (%) Node positive 1 (3) 1 (4) 1 (5) Node negative 11 (31) 10 (38) 13 (62) No dissection 24 (67) 15 (58) 7 (33) PSA = prostate-specific antigen. 228 Nayak et al.  Volume 16  Issue 4  2022 www.currurol.org Figure 1. Kaplan-Meier curve showing overall survival of patients with pT3b adenocarcinoma of the prostate. OS = overall survival. [18] Unadjusted Kaplan-Meier estimates for overall survival were on therapeutic planning. The use of mpMRI has also played an im- generated for patients with pT3b prostate adenocarcinoma, with portant role in selection of candidates for nerve-sparing and pelvic a median overall survival of 96% (p = 0, Fig. 1). Three patients lymph node dissection. Recent studies have suggested that 43% of pa- [19] died, of whom only one death was attributed to prostate cancer. tients with pathological T3b have involved pelvic lymph nodes. Twenty-four patients (51%) who had negative margins underwent Management of patients with pathological T3b can vary from RT (13 [28%] in the adjuvant group and 11 [23%] in the salvage surveillance, to adjuvant and salvage RT and ADT. The presence group), whereas the remaining 23 patients (49%) did not receive of a positive margin has a bearing on the most appropriate treat- any RT treatment (Fig. 2). There was no statistically significant differ- ment offered to the patient. Favorable oncological outcomes with- ence between patients with negative margins who underwent RT (ad- out adjuvant treatment have been observed in patients with a neg- juvant or salvage) compared with no RT (p = 0.84). Twenty-three pa- ative surgical margin and PSA <0.2 μg/L at 1 month following [20] tients (64%) with a positive surgical margin underwent RT (13 [35%] prostatectomy ; however, long-term outcomes are still unclear. in the adjuvant group and 10 [28%] in the salvage group); the remain- Hence, subjecting all patients to RT may lead to overtreatment. ing 23 patients (36%) did not receive any RT treatment (Fig. 3). Pa- Several studies have been designed to help determine the timing [21] tients with a positive margin favored RT (p =0.03).There wasno sta- of RT following prostatectomy. The EORTC 22911 and [22] tistically significant difference between patients undergoing adjuvant Southwest Oncology Group 8794 essentially compared adju- versus salvage RT (p =0.8). vant RT to observation, as not all patients received salvage RT Regarding outcome measures, 8 biochemical progression events were for biochemical progression. Although the Southwest Oncology reported: 5 in the adjuvant RT group and 3 in the salvage RT group over Group trial was the only trial to show a survival benefit for patients an 8-year period (Fig. 4). No difference was found between the adjuvant who received adjuvant RT, it could be attributed to the late use of and salvage groups in terms of biochemical progression-free sur- salvage RT. The EORTC 22911 trial did show a bPFS benefit but vival (bPFS) (p = 0.66). Five-year bPFS was 94% for those in the no overall survival benefit in patients who received adjuvant RT. [23] adjuvant RT group and 97% for those in the salvage RT group. ARO 96-02 trial and the Finnish Radiation Oncology Group [10] trial were smaller trials, with a total of 557 patients, designed to answer the question of salvage versus adjuvant RT. Both tri- 4. Discussion als demonstrated that adjuvant RT reduced the risk of biochem- ical progression. Although these studies demonstrated the benefit Approximately 5% to 18% of patients tend to have pathological in- of adjuvant RT, they did not enlighten us on the optimal timing [6,15–17] volvement of SV following RP. The use of mpMRI has led to of RT. more accurate preoperative staging and has made a significant impact Figure 2. Patients with negative margins receiving adjuvant, salvage, or no radiotherapy. Figure 3. Patients with a positive margin receiving adjuvant, salvage, or no radiotherapy. 229 Nayak et al.  Volume 16  Issue 4  2022 www.currurol.org Figure 4. Kaplan-Meier curve demonstrating biochemical progression-free survival in the adjuvant and salvage radiotherapy groups. The largest randomized controlled trial (n = 1396) to date com- with an initial greater burden of comorbidities. These consider- paring routine adjuvant RT after RP with salvage RT for PSA bio- ations need to be borne in mind when customizing treatment plans [24] chemical progression, RADICALS-RT, showed no benefit with for patients. There is an urgent need to stratify HRPCa patients, to adjuvant RT; however, it did demonstrate an increased risk of uri- better adapt the duration of ADT based on the characteristics of nary and bowel morbidities. Thus, the authors recommended PSA their disease and comorbidities. surveillance as opposed to adjuvant RT. In that study population, Our study has a few limitations, including the retrospective na- 19% of patients had T3b disease, and 63% had positive margins, ture of the study. In addition, some of the patients with T3b disease and subgroup analysis showed no difference in outcomes com- had been recruited in the recently concluded RADICALS-RT study. pared with the rest of the study population. A French multicenter (46 hospitals) open-label, phase 3 trial, [25] 5. Conclusions GETUG-AFU 17, randomized 424 patients to adjuvant or sal- vage RT. They found an increased risk of genitourinary toxicity Our audit corroborates with the recently concluded RADICALS-RT and erectile dysfunction with no oncological benefit in patients re- study, although we had fewer patients with positive margins. Ra- ceiving adjuvant RT versus salvage RT. diotherapy can be avoided in patients with T3b prostate cancer, Another multicenter randomized trial of 333 patients across 32 even if margins are positive, until there is definitive evidence of oncology centers in Australia and New Zealand, TROG 08.03/ PSA recurrence. In keeping with the conclusion of RADICALS-RT, [24] ANZUP RAVES, concluded that biochemical control was sim- salvage RT appears preferable to adjuvant RT. ilar between salvage RT and adjuvant RT; however, salvage RT spared approximately half of men from pelvic radiation, resulting Acknowledgments in significantly lower genitourinary toxicity. [26] None. A prospective systematic review and meta-analysis, ARTISTIC, suggested that adjuvant RT does not improve event-free survival in Statement of ethics men with localized or locally advanced prostate cancer. Until data on long-term outcomes are available, current evidence suggests that According to local institutinal regulations, we confirm that ethical early salvage treatment would reduce the need for pelvic RT in half approval and participants' consent were not required as ethical ap- of the men, therefore reducing associated genitourinary toxicity. proval is not warranted in a retrospective observational study. All Lymph node positivity in patients with T3b prostate cancer is an procedures performed in this study involving human participants important factor that can influence management, as patients with were in accordance with the ethical standards of the institutional positive lymph nodes may go on to have adjuvant chemotherapy and national research committee and with the 1964 Helsinki Decla- or RT. Studies have shown that 11% to 24% of patients with ration and its later amendments or comparable ethical standards. [11,27] T3b disease have positive pathological lymph nodes. The 5-year bPFS in patients with T3b prostate cancer has been Conflict of interest statement [28] found to be extremely variable, ranging from 8% to 68%. Bio- No conflict of interest has been declared by the authors. chemical progression-free survival rates are dependent on variabil- [29–31] ity in PSA level, margin status, and Gleason score. In our se- Funding source ries, 5-year bPFS was 94% in the adjuvant RT group and 97% in the salvage RT group. None. Patients with HRPCa represent a highly heterogeneous group. Most patients will require both RT and long-term ADT. A selected Author contributions subgroup of patients (those with limited local burden of disease, cT3a or initial cT3b, a Gleason score of 7, and PSA <20 ng/mL, AN: Data collection and draft of manuscript; for example) may benefit from a dose escalation into the prostate OET: Statistical analysis; with short-term (6 months) ADT, thus reducing the likelihood of NV: Conceived the study; combined adverse effects. 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Curr Urol extension is associated with an increased risk of death from prostate cancer 2022;16(4):227–231. doi: 10.1097/CU9.0000000000000115

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Published: Dec 31, 2022

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