Management of patients with high-risk and advanced prostate cancer in the Middle East: resource-stratified consensus recommendations

Deborah Mukherji 1, Bassem Youssef 2, Christelle Dagher 3, Albert El-Hajj 4, Rami Nasr 4, Fadi Geara 2, Danny Rabah 5, Saad Al Dousari 6, Rabih Said 7, Raja Ashou 8, Wassim Wazzan 2, Michel Jabbour 9, George Farha 10, Nibras Al Hamdani 11, Yousuf Al Hallaq 11, Hassan Ghazal 12, Haifa Dbouk 13, Bassel Bachir 2, Clement El Khoury 14, Ghazi Sakr 15, Hero K Hussain 16, Khaled Sayyid 17, Khaled Ibrahim 18, Mohammad Haidar 16, Nicolas Zouain 19, Nizar Bitar 20, Walid Alameh 21, Fadi Abbas 22, Sami Faddoul 23, Elie Nemer 24, Georges Assaf 9, Fadi Farhat 18, Muhammad Bulbul 2, Sally Temraz 3, Ali Shamseddine 3, Silke Gillessen 25 26, Aurelius Omlin 26, Raja Khauli 27


 

Affiliations

01 March 2020

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doi: 10.1007/s00345-019-02872-x

Abstract

Purpose: Prostate cancer care in the Middle East is highly variable and access to specialist multidisciplinary management is limited. Academic tertiary referral centers offer cutting-edge diagnosis and treatment; however, in many parts of the region, patients are managed by non-specialists with limited resources. Due to many factors including lack of awareness and lack of prostate-specific antigen (PSA) screening, a high percentage of men present with locally advanced and metastatic prostate cancer at diagnosis. The aim of these recommendations is to assist clinicians in managing patients with different levels of access to diagnostic and treatment modalities.

Methods: The first Advanced Prostate Cancer Consensus Conference (APCCC) satellite meeting for the Middle East was held in Beirut, Lebanon, November 2017. During this meeting a consortium of urologists, medical oncologists, radiation oncologist and imaging specialists practicing in Lebanon, Syria, Iraq, Kuwait and Saudi Arabia voted on a selection of consensus questions. An additional workshop to formulate resource-stratified consensus recommendations was held in March 2019.

Results: Variations in practice based on available resources have been proposed to form resource-stratified recommendations for imaging at diagnosis, initial management of localized prostate cancer requiring therapy, treatment of castration-sensitive/naïve advanced prostate cancer and treatment of castration-resistant prostate cancer.

Conclusion: This is the first regional consensus on prostate cancer management from the Middle East. The following recommendations will be useful to urologists and oncologists practicing in all areas with limited access to specialist multi-disciplinary teams, diagnostic modalities and treatment resources.

Keywords: Consensus; Middle East; Multidisciplinary; Prostate cancer; Resource-stratified recommendations.

Conflict of interest statement

D Mukherji: research funding/honoraria from Astellas, Janssen, and Sanofi. A. Shamseddine: research funding/honoraria from Astellas, Janssen, and Sanofi. R. Khauli: research funding/honoraria from Astellas, Janssen, Hickma, and Algorithm. S. Gillessen: advisory role (including IDMCs) and Speakers Bureau: AAA International, Active Biotech, Amgen, Astellas Pharma, Bayer, Bristol-Myers Squibb, CellSearch, Clovis, CureVac, Dendreon, ESSA Pharmaceuticals, Ferring, Innocrin Pharmaceuticals, Janssen Cilag, MaxiVAX SA, Millenium, Nectar, Novartis, Orion, Pfizer, ProteoMediX, Roche, and Sanofi. Co-inventor on patent application (WO 2009138392 A1) for a method for biomarker discover (granted in China, Europe, Japan and the US). Deputy of the ESMO guidelines committee for GU cancers, member of the EAU guideline panel for prostate cancer, past chair of the EORTC GU group. Member of the STAMPEDE trial management group. All the other authors have no relevant conflicts of interest to declare.

References

 

  1. Gillessen S, et al. Management of patients with advanced prostate cancer: the report of the advanced prostate cancer consensus conference APCCC 2017. Eur Urol. 2018;73(2):178–211. doi: 10.1016/j.eururo.2017.06.002. - DOI - PubMed
  2. Diamond IR, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014;67(4):401–409. doi: 10.1016/j.jclinepi.2013.12.002. - DOI - PubMed
  3. Al-Sukhun S, et al. ASCO resource-stratified guidelines: methods and opportunities. J Glob Oncol. 2018;4:1–8. - PMC - PubMed
  4. Bray F, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424. doi: 10.3322/caac.21492. - DOI - PubMed
  5. Bazarbashi S, et al. Metastatic castration resistant prostate cancer: current strategies of management in the Middle East. Crit Rev Oncol Hematol. 2014;90(1):36–48. doi: 10.1016/j.critrevonc.2013.11.001. - DOI - PubMed
  6. Herget KA, et al. Recent decline in prostate cancer incidence in the United States, by age, stage, and Gleason score. Cancer Med. 2016;5(1):136–141. doi: 10.1002/cam4.549. - DOI - PMC - PubMed
  7. Mukherji D, et al. Prostate cancer stage at diagnosis: first data from a Middle-Eastern cohort. J Clin Oncol. 2017;35(6 suppl):e552–e552. doi: 10.1200/JCO.2017.35.6_suppl.e552. - DOI
  8. Kasivisvanathan V, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018;378(19):1767–1777. doi: 10.1056/NEJMoa1801993. - DOI - PubMed
  9. El-Shater Bosaily A, et al. PROMIS–prostate MR imaging study: a paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer. Contemp Clin Trials. 2015;42:26–40. doi: 10.1016/j.cct.2015.02.008. - DOI - PMC - PubMed
  10. Parker CC, et al. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet. 2018;392(10162):2353–2366. doi: 10.1016/S0140-6736(18)32486-3. - DOI - PMC - PubMed
  11. James ND, et al. Abiraterone for prostate cancer not previously treated with hormone therapy. N Engl J Med. 2017;377(4):338–351. doi: 10.1056/NEJMoa1702900. - DOI - PMC - PubMed
  12. James ND, et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016;387(10024):1163–1177. doi: 10.1016/S0140-6736(15)01037-5. - DOI - PMC - PubMed
  13. Sweeney CJ, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med. 2015;373(8):737–746. doi: 10.1056/NEJMoa1503747. - DOI - PMC - PubMed
  14. Fizazi K, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med. 2017;377(4):352–360. doi: 10.1056/NEJMoa1704174. - DOI - PubMed
  15. Gandaglia G, et al. Distribution of metastatic sites in patients with prostate cancer: a population-based analysis. Prostate. 2014;74(2):210–216. doi: 10.1002/pros.22742. - DOI - PubMed
  16. Viers BR, et al. Primary Gleason grade 4 at the positive margin is associated with metastasis and death among patients with Gleason 7 prostate cancer undergoing radical prostatectomy. Eur Urol. 2014;66(6):1116–1124. doi: 10.1016/j.eururo.2014.07.004. - DOI - PubMed
  17. Carrie C, et al. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016;17(6):747–756. doi: 10.1016/S1470-2045(16)00111-X. - DOI - PubMed
  18. Bianchi L, et al. The role of prostate-specific antigen persistence after radical prostatectomy for the prediction of clinical progression and cancer-specific mortality in node-positive prostate cancer patients. Eur Urol. 2016;69(6):1142–1148. doi: 10.1016/j.eururo.2015.12.010. - DOI - PubMed
  19. Stephenson AJ, et al. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol. 2007;25(15):2035–2041. doi: 10.1200/JCO.2006.08.9607. - DOI - PMC - PubMed
  20. Fossati N et al (2017) Impact of early salvage radiation therapy in patients with persistently elevated or rising prostate-specific antigen after radical prostatectomy. Eur Urol - PubMed
  21. Abugharib A, et al. Very early salvage radiotherapy improves distant metastasis-free survival. J Urol. 2017;197(3 Pt 1):662–668. doi: 10.1016/j.juro.2016.08.106. - DOI - PubMed
  22. Perera M et al (2019) Gallium-68 prostate-specific membrane antigen positron emission tomography in advanced prostate cancer-updated diagnostic utility, sensitivity, specificity, and distribution of prostate-specific membrane antigen-avid lesions: a systematic review and meta-analysis. Eur Urol - PubMed
  23. Shipley WU, et al. Radiation with or without antiandrogen therapy in recurrent prostate cancer. N Engl J Med. 2017;376(5):417–428. doi: 10.1056/NEJMoa1607529. - DOI - PMC - PubMed
  24. Rosenthal SA et al (2019) Effect of chemotherapy with docetaxel with androgen suppression and radiotherapy for localized high-risk prostate cancer: the randomized phase III NRG oncology RTOG 0521 trial. J Clin Oncol JCO1802158 - PMC - PubMed
  25. Viani GA, et al. Intensity-modulated radiotherapy reduces toxicity with similar biochemical control compared with 3-dimensional conformal radiotherapy for prostate cancer: a randomized clinical trial. Cancer. 2016;122(13):2004–2011. doi: 10.1002/cncr.29983. - DOI - PubMed
  26. Morgan SC, et al. Hypofractionated radiation therapy for localized prostate cancer: executive summary of an ASTRO, ASCO, and AUA evidence-based guideline. Pract Radiat Oncol. 2018;8(6):354–360. doi: 10.1016/j.prro.2018.08.002. - DOI - PubMed
  27. Nabid A, et al. Duration of androgen deprivation therapy in high-risk prostate cancer: a randomized phase III trial. Eur Urol. 2018;74(4):432–441. doi: 10.1016/j.eururo.2018.06.018. - DOI - PubMed
  28. Geara FB, et al. Nadir PSA is a strong predictor of treatment outcome in intermediate and high risk localized prostate cancer patients treated by definitive external beam radiotherapy and androgen deprivation. Radiat Oncol. 2017;12(1):149. doi: 10.1186/s13014-017-0884-y. - DOI - PMC - PubMed
  29. Smith MR, Yu MK, Small EJ. Apalutamide and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(26):2542. doi: 10.1056/NEJMe1805733. - DOI - PubMed
  30. Hussain M, et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2018;378(26):2465–2474. doi: 10.1056/NEJMoa1800536. - DOI - PubMed
  31. Fizazi K, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235–1246. doi: 10.1056/NEJMoa1815671. - DOI - PubMed
  32. Sydes MR, et al. Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol. Ann Oncol. 2018;29(5):1235–1248. doi: 10.1093/annonc/mdy072. - DOI - PMC - PubMed
  33. Aguiar PN, Jr et al (2019) Cost-effectiveness analysis of abiraterone, docetaxel or placebo plus androgen deprivation therapy for hormone-sensitive advanced prostate cancer. Einstein (Sao Paulo) 17(2):eGS4414 - PMC - PubMed
  34. Kyriakopoulos CE, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED trial. J Clin Oncol. 2018;36(11):1080–1087. doi: 10.1200/JCO.2017.75.3657. - DOI - PMC - PubMed
  35. Szmulewitz RZ, et al. Prospective international randomized phase II study of low-dose abiraterone with food versus standard dose abiraterone in castration-resistant prostate cancer. J Clin Oncol. 2018;36(14):1389–1395. doi: 10.1200/JCO.2017.76.4381. - DOI - PMC - PubMed
  36. Aggarwal R, et al. Clinical and genomic characterization of treatment-emergent small-cell neuroendocrine prostate cancer: a multi-institutional prospective study. J Clin Oncol. 2018;36(24):2492–2503. doi: 10.1200/JCO.2017.77.6880. - DOI - PMC - PubMed
  37. Chakhtoura M, et al. The FRAX-based Lebanese osteoporosis treatment guidelines: rationale for a hybrid model. Osteoporos Int. 2017;28(1):127–137. doi: 10.1007/s00198-016-3766-5. - DOI - PubMed
  38. Fizazi K, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377(9768):813–822. doi: 10.1016/S0140-6736(10)62344-6. - DOI - PMC - PubMed
  39. Saad F. Zoledronic acid significantly reduces pathologic fractures in patients with advanced-stage prostate cancer metastatic to bone. Clin Prostate Cancer. 2002;1(3):145–152. doi: 10.3816/CGC.2002.n.016. - DOI - PubMed
  40. Saad F, et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst. 2004;96(11):879–882. doi: 10.1093/jnci/djh141. - DOI - PubMed
  41. Himelstein AL, et al. Effect of longer-interval vs standard dosing of zoledronic acid on skeletal events in patients with bone metastases: a randomized clinical trial. JAMA. 2017;317(1):48–58. doi: 10.1001/jama.2016.19425. - DOI - PMC - PubMed

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