CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer

Summary

The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are: 1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC. 2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment. 3. To explore the relationship between stage efficacy and clinical prognosis. 4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy. Participants will undergo systemic therapy combined with cytoreductive prostatectomy. Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies.

Timeline

Start

2024-03-21

Primary completion

2028-12-31

Completion

2028-12-31

Publications

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• Background Efstathiou E, Davis JW, Pisters L, Li W, Wen S, McMullin RP, Gormley M, Ricci D, Titus M, Hoang A, Zurita AJ, Tran N, Peng W, Kheoh T, Molina A, Troncoso P, Logothetis CJ. Clinical and Biological Characterisation of Localised High-risk Prostate Cancer: Results of a Randomised Preoperative Study of a Luteinising Hormone-releasing Hormone Agonist with or Without Abiraterone Acetate plus Prednisone. Eur Urol. 2019 Oct;76(4):418-424. doi: 10.1016/j.eururo.2019.05.010. Epub 2019 Jun 6.
• Background Connor MJ, Shah TT, Horan G, Bevan CL, Winkler M, Ahmed HU. Cytoreductive treatment strategies for de novo metastatic prostate cancer. Nat Rev Clin Oncol. 2020 Mar;17(3):168-182. doi: 10.1038/s41571-019-0284-3. Epub 2019 Nov 11.
• Background Powell IJ, Tangen CM, Miller GJ, Lowe BA, Haas G, Carroll PR, Osswald MB, DeVERE WHITE R, Thompson IM Jr, Crawford ED. Neoadjuvant therapy before radical prostatectomy for clinical T3/T4 carcinoma of the prostate: 5-year followup, Phase II Southwest Oncology Group Study 9109. J Urol. 2002 Nov;168(5):2016-9. doi: 10.1016/S0022-5347(05)64285-1.
• Background Gratzke C, Engel J, Stief CG. Role of radical prostatectomy in metastatic prostate cancer: data from the Munich Cancer Registry. Eur Urol. 2014 Sep;66(3):602-3. doi: 10.1016/j.eururo.2014.04.009. Epub 2014 May 10. No abstract available.
• Background 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 Mar;193(3):832-8. doi: 10.1016/j.juro.2014.09.089. Epub 2014 Sep 22.
• Background Buelens S, Poelaert F, Claeys T, De Bleser E, Dhondt B, Verla W, Ost P, Rappe B, De Troyer B, Verbaeys C, Kimpe B, Billiet I, Plancke H, Fransis K, Willemen P, Ameye F, Decaestecker K, Lumen N. Multicentre, prospective study on local treatment of metastatic prostate cancer (LoMP study). BJU Int. 2022 Jun;129(6):699-707. doi: 10.1111/bju.15553. Epub 2021 Aug 8.
• Background Parker CC, James ND, Brawley CD, Clarke NW, Hoyle AP, Ali A, Ritchie AWS, Attard G, Chowdhury S, Cross W, Dearnaley DP, Gillessen S, Gilson C, Jones RJ, Langley RE, Malik ZI, Mason MD, Matheson D, Millman R, Russell JM, Thalmann GN, Amos CL, Alonzi R, Bahl A, Birtle A, Din O, Douis H, Eswar C, Gale J, Gannon MR, Jonnada S, Khaksar S, Lester JF, O'Sullivan JM, Parikh OA, Pedley ID, Pudney DM, Sheehan DJ, Srihari NN, Tran ATH, Parmar MKB, Sydes MR; Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet. 2018 Dec 1;392(10162):2353-2366. doi: 10.1016/S0140-6736(18)32486-3. Epub 2018 Oct 21.
• Background Eastham JA, Heller G, Halabi S, Monk JP 3rd, Beltran H, Gleave M, Evans CP, Clinton SK, Szmulewitz RZ, Coleman J, Hillman DW, Watt CR, George S, Sanda MG, Hahn OM, Taplin ME, Parsons JK, Mohler JL, Small EJ, Morris MJ. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer. J Clin Oncol. 2020 Sep 10;38(26):3042-3050. doi: 10.1200/JCO.20.00315. Epub 2020 Jul 24.
• Background Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.
• Background 中国医促会泌尿健康促进分会, 中国研究型医院学会泌尿外科学专业委员会. 腹腔镜(含机器人辅助)前列腺癌根治术安全共识. 现代泌尿外科杂志. 2020;25(7):575-84.
• Background 中国医疗保健国际交流促进会泌尿健康促进分会, 中国研究型医院学会泌尿外科学专业委员会. 前列腺癌新辅助治疗安全共识. 现代泌尿外科杂志. 2023;28(1):18-23,8.
• Background 中华医学会泌尿外科学分会, 中国前列腺癌联盟. 转移性前列腺癌化疗中国专家共识(2019版). 中华泌尿外科杂志. 2019;40(10):721-5.
• Background 中国医促会泌尿健康促进分会, 中国研究型医院学会泌尿外科学专业委员会. 前列腺癌放射治疗安全共识. 现代泌尿外科杂志. 2019;24(5):336-46.

Drugs

Indications