KO 15. 고위험 전립선암 환자에서 능동적 감시는 근치적 전립선절제술에 비해 생존율이 낮은가?

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권고사항 권고수준 근거수준
고위험 전립선암 환자에서 근치적 전립선 절제술을 시행하는 것이 능동적 감시보다 생존율을 향상시키므로 근치적 전립선 절제술을 시행하는 것을 권고 한다. B II

개요

능동적 감시는 전립선암의 경과를 적극적으로 추적 관찰하면서 적절한 시기에 전립선 절제술이나 방사선 치료 등 근치적인 치료를 시행하는 것이다(NCCN Guidelines Version 3.2016). 일부의 전립선암은 환자의 기대여명에 영향을 끼치지 않으며 치료로 인한 합병증 및 사회적인 치료 비용의 증가도 문제가 되고 있다. 따라서 능동적 감시는 전립선암의 과다 치료에 의한 의료비용의 감소 또는 환자의 삶의 질을 보존하기 위해 시행되며 이를 위해 추적 관찰 중 적절한 시점에 적극적 치료로 변경하는 것이 필요하다. 또한 능동적 감시는 신중하게 선택된 저위험군 환자에게만 적용되어야 한다(EAUESTRO-SIOG Guidelines on Prostate Cancer, 2016).

현재로서는 고위험군의 전립선암 환자에서 능동적 감시와 근치적 절제술을 시행한 결과를 직접적으로 비교한 연구는 그리 많지 않은 상황이다. Bill-Axelson 등은 전립선암 환자를 근치적 절제술군과 감시 관찰군으로 무작위 배정하여 18년간 관찰한 전향적 연구를 보고하였다. 이 중 고위험군 환자의 경우 근치적 전립선 절제술을 시행하여도 감시 관찰을 시행한 고위험 환자군에 비해 전체 사망률, 암-특이 사망률, 원격 전이의 위험을 감소시키지 못하는 것으로 나타나 고위험 환자군에서도 능동적 감시가 유효할 것을 시사하였다[1].

하지만 이에 반대되는 연구들이 보고되어 있는데 미국의 Tewari 등은 고위험도 전립선암 환자 453명을 대상으로 보존적 치료, 근치적 방사선 치료, 근치적 전립선 절제술을 시행하고 관찰한 연구결과를 발표하였다. 이 연구에서 전체 생존기간의 중앙값은 5.2, 6.7, 9.7년으로 보존적 치료에서 가장 낮았고 근치적 전립선 절제술 시행군에서 가장 높았다. 암 특이 생존기간의 중앙값도 보존적 치료에서는 7.8년으로 낮았으며 방사선치료와 근치적 전립선 절제술 군에서 14년 이상으로 더욱 좋은 결과를 보였다[2].

또한 2012년에 Wilt 등이 발표한 PIVOT 연구에서는 전립선암 환자를 무작위로 감시 관찰군과 근치적 전립선 절제술 두 군으로 나누어 10년 이상 관찰한 결과를 발표하였다[3]. 이 연구에서 고위험 도 전립선 환자군에서는 근치적 전립선 절제를 시행할 경우 감시 관찰하는 경우보다 전체 사망률이 6.7% 감소되는 것으로 나타났으나 통계적으로 유의한 차이를 보이지는 못하였지만 근치적 전립선 절제술을 시행한 PSA 10 ng/mL 초과 또는 중간위험도 이상의 환자에서 암 특이 사망률이 감시 관찰 시행군에 비해 9-11% 유의하게 감소하는 결과가 나타나 고위험도 전립선암 환자에서 근치적 전립선 절제술 시행이 종양학적 성적을 높일 수 있음을 보였다. 이러한 연구결과를 바탕으로 기존의 국내 및 해외 가이드라인에서 고위험 전립선암 환자에 대해 능동적 감시를 권고하지 않고 있다.

기존 가이드라인 요약 및 수용성, 적용성 평가

2015 KUOS 전립선암 진료지침에서는 고위험군 이상의 전립선암 환자에서 선택적으로 근치적 전립선 절제술이 유용할 수 있다고 하였고 2007년 미국비뇨의학과학회 진료지침에서는 근치적 전립선 절제술은 전립선암의 재발율을 낮추고 생존율을 향상시킨다고 하였다. 2014년 NICE 진료지침에서는 고위험 국소 전립선암 환자들에게 능동적 감시를 시행하지 말 것을 권고하고 있다. 2016년 유럽비뇨의학과학회 진료지침에서는 기대여명이 10명 초과인 고위험/국소 진행성 전립선암 환자들에게 전립선절제술을 비롯한 복합 치료를 시행할 것을 권고하는 반면 수술이나 방사선 치료 등을 시행할 수 없는 환자나 기대 여명이 짧은 고위험 국소 전립선암 환자들에게는 주의 깊은 관찰을 시행하는 것을 권고하고 있다. 요약하면 고위험 전립선암 환자에서 근치적 전립선 절제술을 시행하는 것이 능동적 감시보다 재발의 위험을 낮추고 생존율을 향상시키므로 근치적 전립선 절제술을 시행하는 것을 권고한다.

KQ 15. 고위험 전립선암 환자에서 능동적 감시는 근치적 전립선절제술에 비해 생존율이 낮은가?
지침(제목) 권고 권고등급 근거수준 page
1. 2015 KUOS 고위험도군 이상의 전립선암 환자에서도 선택적으로 근치적 전립선절제술이 유용할 수 있는데, 혈청전립선특이항원 10 ng/ml 이상, 임상적 병기T2b 이상, Gleason score 9 이상, 고위험 등급 암의 코어 수가 더 많음, 또는 코어의 50% 이 상 암이 침범함 등의 인자를 고려하여 근치적 전립선절제술 시행을 결정할 수 있다 제시안함 2b 36
2. EAU 2016  High risk localised: Offer watchful waiting to patients not eligible for local curative treatment and those with a short life expectancy. 제시안함 제시안함 71
3. AUA 2007 High-risk patients who are considering specific treatment options should be informed of findings of recent high-quality clinical trials, including that: When compared with watchful waiting, radical prostatectomy may lower the risk of cancer recurrence and improve survival; and For those considering external beam radiotherapy, use of hormonal therapy combined with conventional radiotherapy may prolong survival standard: 제시안함 31
6. NICE 2014 Do not offer active surveillance to men with high-risk localised prostate cancer. 제시안함 제시안함 166
지침(제목) 1. 2015 KUOS 2. EAU 2016  3. AUA 2007 5. NICE 2014
수용성 인구 집단(유병률, 발생률 등)이 유사하다. 아니오 아니오 아니오
가치와 선호도가 유사하다.
권고로 인한 이득은 유사하다
해당 권고는 수용 할 만하다. 
적용성 해당 중재/장비는 이용 가능하다. 
필수적인 전문기술이 이용 가능하다.
법률적/제도적 장벽이 없다. 
해당 권고는 적용 할 만하다. 

업데이트 근거 요약

2015년에 Lei 등은 고위험 전립선암 환자에서의 첫번째 치료 옵션에 대한 체계적 문헌 고찰을 시행하여 근치적 전립선절제술, 방사선치료, 근접치료, 호르몬치료, 관찰 요법 등의 장기간 생존 성적을 비교하였다. 치료 성적은 근치적 전립선절제술과 남성 호르몬 억제 요법을 동반한 방사선치료가 가장 좋은 것으로 밝혀졌고 방사선치료 단독 요법, 남성 호르몬 억제 요법 및 관찰의 순서로 치료 성적이 좋았다. 전체 생존율은 근치적 전립선절제술 군에서 의미있게 높았으며 암 특이 사망률은 가장 낮았다. 관찰 요법은 가장 나쁜 결과를 보여주었다[4].

Johnston 등은 2017년에 European urology에 ProtecT 연구에서 탈락한 임상병기 T3-4 또는 PSA>20 이상의 국소 진행성이거나 국소/원격 전이 전립선암 환자를 대상으로 중앙값 7.4년간 추적 관찰한 연구 결과를 발표하였다[5]. 이 연구에서 능동적 감시 또는 대기관찰을 시행한 환자군과의 단독 비교는 이루어지지 않았으나 일차적 호르몬 치료를 받았거나 완화 항암화학요법, 관찰 등을 시행한 환자들을 비근치적 치료군으로 묶어 근치적 전립선 절제술군 및 근치적 방사선 치료군과 결과를 비교 하였다. 근치적 전립선 절제술 시행군은 근치적 방사선 치료군에 비해 유의하지는 않지만 전체 생존율과 암 특이 생존율이 높았고 비근치적 치료 시행군보다 유의하게 전체 생존율과 암 특이 생존율이 높았다.

기존의 가이드라인에 이미 고위험 환자군에서 능동적 감시가 적절하지 않음이 반영되어 있고[3] 고위험 환자군에서 일차치료로 근치적 전립선 절제술이나 근치적 방사선 치료가 보존적 치료나 능동적 감시보다 우월함을 암시하는 증거들이 추가되고 있다. 이를 바탕으로 고위험 전립선암 환자에 대해서는 능동적 감시보다 근치적 치료를 시행하는 것이 필요할 것으로 보인다.

참고문헌

1. Bill-Axelson A, Holmberg L, Garmo H, et al. Radical Prostatectomy or Watchful Waiting in Early Prostate Cancer. N Engl J Med 2014:370(10):932-42.

2. Tewari A, Divine G, Chang P, et al. Long-Term Survival in Men With High Grade Prostate Cancer: A Comparison Between Conservative Treatment, Radiation Therapy and Radical Prostatectomy-A Propensity Scoring Approach. J Urol 2007:177(3):911-5..

3. Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. | N Engl J Med 2012:367(3):203-13.

4. Lei JH, Liu LR, Wei Q, et al. Systematic review and meta-analysis of the survival outcomes of first-line treatment options in high-risk prostate cancer. Sci Rep 2015;5:7713.

5. Johnston TJ, Shaw GL, Lamb AD, et al. Mortality Among Men with Advanced Prostate Cancer Excluded from the Protect Trial. Eur Urol 2017;71(3):381-8.

6. Heidenreich A, Pfister D, Porres D. Cytoreductive radical prostatectomy in patients with prostate cancer and low volume skeletal metastases: Results of a feasibility and case-control study. J Urol 2015:193(3):832-8.

7. Ghadjar P, Briganti A, De Visschere PJL, et al. The oncologic role of local treatment in primary metastatic prostate cancer. World J Urol 2015:33(6):755-61.

8. Di Benedetto A, Soares R, Dovey Z, et al. Laparoscopic radical prostatectomy for high-risk prostate cancer. BJU Int 2015;115(5):780-6.

9. Everaerts W, Van Rij S, Reeves F, et al. Radical treatment of localised prostate cancer in the elderly. BJU Int 2015;116(6):847-52.

10. Gözen AS, Akin Y, Ates M, et al. Impact of laparoscopic radical prostatectomy on clinical T3 prostate cancer: Experience of a single centre with long-term follow-up. BJU Int 2015;116(1):102-8.

11. Bratt o, Folkvaljon Y, Eriksson MH, et al. Undertreatment of men in their seventies with high-risk nonmetastatic prostate cancer. Eur Urol 2015;68(1):53-8.

12. Wiegel T, Bartkowiak D, Bottke D, et al. Prostate-specific antigen persistence after radical prostatectomy as a predictive factor of clinical relapse-free survival and overall survival: 10-year data of the ARO 96-02 trial. Int J Radiat Oncol Biol Phys 2015:91(2):288-94.

13. Abdollah F, Klett DE, Sood A, et al, Predicting pathological outcomes in patients undergoing robot-assisted radical prostatectomy for high-risk prostate cancer: A preoperative nomogram. BJŲ Int 2015;116(5):703-12.

14. Jo JK, Kook HR, Byun S-S, et al. Stratification of Contemporary Patients Undergoing Radical Prostatectomy for High-risk Prostate cancer. Ann Surg Oncol 2015;22(6):2088-93.

15. Dell'Oglio P, Karnes RJ, Joniau S, et al. Very long-term survival patterns of young patients treated with radical prostatectomy for high-risk prostate cancer. Urol Oncol 2016;34(5):234.e13-9.

16. Briganti A, Karnes RJ, Gandaglia G, et al. Natural history of surgically treated high-risk prostate cancer. Urol Oncol 2015;33(4):163.e7-13.

17. Koie T, Mitsuzuka K, Yoneyama T, et al. Prostate-specific antigen density predicts extracapsular extension and increased risk of biochemical recurrence in patients with high-risk prostate cancer who underwent radical prostatectomy. Int J Clin Oncol 2015;20(1):176-81.

18. Lanchon C, Shariat SF, Roupret M. The role for surgery in high-risk prostate cancer. Wien Med Wochenschr 2015;165(19-20):395-400.

19. Djaladat H, Amini E, Xu W, Cai J, Daneshmand S, Lieskovsky G. Oncological Outcomes After Radical Prostatectomy for High-Risk Prostate cancer Based on New Gleason Grouping System: A Validation Study From University of Southern California With 3,755 Cases. Prostate 2017:77(7):743-8.

근거표

KQ15
Reference 1. Lei JH, Liu LR, Wei Q, et al. Systematic review and meta-analysis of the survival outcomes of first-line treatment options in high-risk prostate cancer. Sci Rep 2015;5:7713. 

Study 

Study type Systematic review
Patients
Purpose of Study To compare the long-term survival outcomes of RP, RT, BT, ADT, and watchful waiting (WW), alone or in combination, in patients with high-risk PCa.
Study Results The overall priority for treatment strategy could be ranked as follows: RP/(RT plus ADT), RT, and ADT/WW. RP had significant better overall survival (OS) than RT or BT, and RP had significant lower cancer-specific mortality (CSM) than RT (0.51 [95% CI 0.30-0.73], P<0.001).
Level of Study 1
Reference 2. Johnston TJ, Shaw GL, Lamb AD, et al. Mortality Among Men with Advanced Prostate Cancer Excluded from the Protect Trial. Eur Urol 2017;71(3):381-8.
Study type Large, multicenter, non-randomized controlled trial
Patients 492 men 
Purpose of Study To determine outcomes for men diagnosed with advanced PCa following prostate-specific antigen (PSA) testing who were excluded from the ProtecT randomised trial. 
Study Results All-cause mortality was 7% (4/54) among men who underwent RP (2 died of PCa; 4%) and 15% (37/245) among those who received RT (12 died of PCa; 5%). All-cause mortality was higher among men who underwent non-radical treatment (51/133; 38%) and men whose treatments were unknown (25/60; 42%; all p<0.0001) There was a much higher risk of death from PCa (HR 6.70, 95% CI 2.64-16.9; p<0.0001) and all causes (HR 4.55, 95% CI 2.42-8.52; p<0.0001) among men who received nonradical treatment compared to those who underwent radical treatment
Level of Study 2
Reference 3. Heidenreich A, Pfister D, Porres D. Cytoreductive radical prostatectomy in patients with prostate cancer and low volume skeletal metastases: Results of a feasibility and case-control study. J Urol 2015;193(3):832-8. 
Study type Case-control study
Patients 23 cytoreductive radical prostatectomy patients (Group 1) and 38 control patients (Group 2)
Purpose of Study To explore the role of cytoreductive radical prostatectomy in prostate cancer with low volume skeletal metastases in terms of a in terms of a feasibility study.
Study Results  Median time to castration resistant prostate cancer was 40 months (range 9 to 65) and 29 months (range 16 to 59) in groups 1 and 2, respectively (p=0.04). Patients in group 1 experienced significantly better clinical progression-free survival (38.6 vs 26.5 months, p=0.032) and cancer specific survival rates (95.6% vs 84.2%, p=0.043), whereas overall survival was similar.
Level of Study 2
Reference  4. Ghadjar P, Briganti A, De Visschere PJL, et al. The oncologic role of local treatment in primary metastatic prostate cancer. World J Urol 2015;33(6):755-61. 
Study type Systematic Review
Patients
Purpose of Study To determine the oncologic benefit or otherwise of local treatment of the prostate in patients with primary metastatic prostate cancer.
Study Results Retrospective series and population-based data suggest that the use of local treatment of the prostate in patients with primary metastatic prostate cancer may improve cancerspecific survival and overall survival com- pared with treating these patients with androgen depriva- tion therapy alone. The clinical outcome in metastatic pros- tate cancer is largely determined by the extent of lymph node involvement and overall metastatic burden. Contemporary data are lacking to recommend one alternative of local therapy (radiotherapy or radical prostatectomy) over the other. 

Level 

Level of Study 1
Reference 5. Di Benedetto A, Soares R, Dovey Z, et al. Laparoscopic radical prostatectomy for high-risk prostate cancer. BJU Int 2015;115(5):780-6.
Study type Cohort study
Patients 446 patients
Purpose of Study To investigate the results of performing laparoscopic radical prostatectomy (LRP) in patients with high-risk prostate cancer (HRPC): PSA level of ≥20 ng/mL ± biopsy Gleason ≥8 ± clinical T stage ≥2c.
Study Results The low morbidity, 55.4% specimen-confinement rate, 26.0% PSM rate, 79.2% biochemical disease-free survival, 91.8% continence rate and 64.4% potency rate, at 35.2 months in the present study serve as evidence firstly that surgery is an effective treatment for patients with HRPC, curing many and representing the first step of multi-modal treatment for others, and that LRP for HRPC appears to be as effective as open RP in this context.
Level of Study 2
Reference 6. Everaerts W, Van Rij S, Reeves F, et al. Radical treatment of localised prostate cancer in the elderly. BJU Int 2015;116(6):847-52. 
Study Results Systematic Review
Patients
Purpose of Study To review addresses the evidence for radical treatment of clinically localised intermediate- and high-risk prostate cancer in older men
Study Results Results from this study showed a lack of benefit for treatment in those with low-risk prostate cancer. However, in those with intermediate- to high-risk disease there was a strong trend to a decrease in all-cause mortality 
Level of Study 1
Reference 7. Gözen AS, Akin Y, Ates M, et al. Impact of laparoscopic radical prostatectomy on clinical T3 prostate cancer: Experience of a single centre with long-term follow-up. BJU Int 2015;116(1):102-8. 
Study type Case-control study
Patients 417 patients (cT1), 842 patients (cT2), 492 patients (cT3)
Purpose of Study To investigate the oncological safety and effectiveness of laparoscopic radical prostatectomy (LRP) for patients with clinical T3 (cT3) prostate cancer compared with patients with cT1 and cT2 prostate cancer. Group 3 showed 99.8%, 97.4 of cancer-specific survival at 5, 10 year follow-up respectively. Its overall survival at 5, 10 years were 99.1, 93.4% respectively.
Study Results Group 1 had the best cancer-specific survival rate, whereas overall survival (OS) rates and complications were similar in all groups. 
Level of Study 2
Reference 8. Bratt O, Folkvaljon Y, Eriksson MH, et al. Undertreatment of men in their seventies with high-risk nonmetastatic prostate cancer. Eur Urol 2015;68(1):53-8.
Study type Cohort study
Patients 19,190 patient
Purpose of Study  To investigate how age and comorbidity affect treatment of men with HRnMPCa. 
Study Results Otherwise healthy men in their seventies with HRnMPCa were less likely to receive radical treatment than younger men with a similar life expectancy, although increasing use of radical treatment was observed during the study period. Our findings highlight the need for improved methods for clinical decision-making, including improved assessment of life expectancy.
Level of Study 2
Reference 9. Wiegel T, Bartkowiak D, Bottke D, et al. Prostate-specific antigen persistence after radical prostatectomy as a predictive factor of clinical relapse-free survival and overall survival: 10year data of the ARO 96-02 trial. Int J Radiat Oncol Biol Phys 2015;91(2):288-94.  
Study type Cohort study
Patients 388 patients with pT3-4pN0 prostate cancer with positive or negative surgical margins
Purpose of Study To report the outcome with up to 12 years of follow-up of patients who retained a post-RP detectable PSA and received salvage radiation therapy
Study Results Patients who detained post-RP detectable PSA had worse outcome results compared with those whose post-RP PSA was undetectable (a 10-year metastasis-free survival of 67% versus 83%and overall survival of 68% versus 84%, respectively)
Level of Study 2
Reference 10. Abdollah F, Klett DE, Sood A, et al. Predicting pathological outcomes in patients undergoing robot-assisted radical prostatectomy for high-risk prostate cancer: A preoperative nomogram. BJU Int 2015;116(5):703-12. 
Study type Cohort study
Patients 810 patients
Purpose of Study To identify which high-risk patients with prostate cancer may harbor favourable pathological outcomes at radical prostatectomy
Study Results Patients with specimen confined disease (SCD) had significantly higher 8-year biochemical recurrence (72.7% vs 31.7%, P<0.001) and cancer-specific free survival rates (100% vs 86.9%, P<0.001) than patients with non-SCD.
Level of Study 2
Reference 11. Jo JK, Kook HR, Byun S-S, et al. Stratification of Contemporary Patients Undergoing Radical Prostatectomy for High-risk Prostate Cancer. Ann Surg Oncol 2015;22(6):2088-93. 
Study type Cohort study
Patients 1,905 patients
Purpose of Study To identify more precise risk stratification system for contemporary high-risk prostate cancer. 
Study Results primary Gleason 5 pattern on biopsy (p=0.008) and multiple (C2) high-risk criteria (p<0.001) were observed to be independent predictors of the risk of biochemical recurrence amongst high-risk group undergoing RP
Level of Study 2
Reference 12. Dell’Oglio P, Karnes RJ, Joniau S, et al. Very long-term survival patterns of young patients treated with radical prostatectomy for high-risk prostate cancer. Urol Oncol 2016;34(5):234.e13-9. 
Study type Multicenter longitudinal study
Patients 446 patients
Purpose of Study To evaluate long-term survival patterns in young patients treated with radical prostatectomy (RP) for HRPCa.
Study Results The 10-, 15- and 20-year CSM and OCM rates were 11.6% and 5.5% vs. 15.5% and 13.5% vs. 18.4% and 19.3%, respectively. The 5-year probability of CSM and OCM rates among patients who survived at 5, 10, and 15 years after RP, were 6.4% and 2.7% vs. 4.6% and 9.6% vs. 4.2% and 8.2%, respectively. Year of surgery, pathological stage and Gleason score, surgical margin status and lymph node invasion were the major determinants of CSM (all P≤0.03). Conversely, none of the covariates was significantly associated with OCM (all P≥0.09).
Level of Study 2
Reference 13. Briganti A, Karnes RJ, Gandaglia G, et al. Natural history of surgically treated high-risk prostate cancer. Urol Oncol 2015;33(4):163.e7-3. 
Study type Multicenter longitudinal study
Patients 2,065 patients
Purpose of Study To evaluate the natural history of PCa in patients treated with radical prostatectomy (RP) alone.
Study Results Overall, the 5-year BCR-free survival rate was 55.2%. Given the BCR-free survivorship at 1, 2, 3, 4, and 5 years, the BCR-free survival rates improved by +7.6%, +4.1%, +4.8%, +3.2%, and +3.7%, respectively. Overall, the 10-year CSM rate was 14.8%. When patients were stratified according to time to BCR, patients experiencing BCR within 36 months from surgery had higher 10-year CSM rates compared with those experiencing late BCR (19.1% vs. 4.4%; P<0.001). At multivariate analyses, time to BCR represented an independent predictor of CSM (P<0.001)
Level of Study 2
Reference 14. Koie T, Mitsuzuka K, Yoneyama T, et al. Prostate-specific antigen density predicts extracapsular extension and increased risk of biochemical recurrence in patients with highrisk prostate cancer who underwent radical prostatectomy. Int J Clin Oncol 2015;20(1):17681. 

Study 

Study type Multicenter longitudinal study
Patients 380 high risk patients
Purpose of Study To predict pathological and oncological outcomes in high-risk PCa patients who underwent RP
Study Results PSAD was an independent predictor of adverse pathologic stage. The 5-year PSA-free survival rates were 82.9% for patients with PSAD≤0.468 and 50.7% for those with PSAD>0.468 (P<0.0001).
Level of Study 2
Reference 15. Lanchon C, S FS, Roupret M. The role for surgery in high-risk prostate cancer. Wien Med Wochenschr 2015;165(19-20):395-400.
Study type Review
Patients
Purpose of Study To analyze clinical outcomes after RP for high-risk PCa and to determine the role of surgery compared with other possible treatments in this population.
Study Results Recent series have shown very promising results of radical prostatectomy (RP)—alone or part as a multimodality approach— in patients with high-risk PCa, with satisfactory survival curves even though biochemical recurrence rate was high. Adjuvant treatment (radiotherapy (RT) alone or combined with androgen deprivation) was necessary in 20 to 54% of patients, notably in cases with positive surgical margins. As for functional outcomes, urinary continence was preserved in about 92% of cases and overall potency in 60%. When comparing RP versus RT as primary treatment for high-risk PCa, a recent meta- analysis found surgery to be associated with an improved cancer-specific mortality compared with RT.
Level of Study 1
Reference 16. Djaladat H, Amini E, Xu W, et al. Oncological Outcomes After Radical Prostatectomy for High-Risk Prostate Cancer Based on New Gleason Grouping System: A Validation Study From University of Southern California With 3,755 Cases. Prostate 2017;77(7):743-8.
Study type Retrospective cohort study
Patients 226 (GS 8) and 132 (GS 9-10) patients
Purpose of Study To assess the prognostic value of new Gleason grade grouping system in high-risk prostate cancer patients, we compared oncological outcomes after radical prostatectomy for patients with Gleason score 8 versus 9-10
Study Results Gleason 9-10 prostate cancer was associated with worse biochemical (HR 1.6; 95%CI [1.1-2.3]) and clinical recurrence free survival (HR 1.9; 95%CI [1.1-3.3]); however, overall survival did not differ significantly between the groups. Significant differences were in disease-specific outcomes between patients with Gleason score 8 versus 9-10.
Level of Study 2