Non-interventional study of treatment approaches in patients with locally advanced prostate cancer who have undergone prostatectomy or radiation therapy (PREVENT)

Background. Prostate cancer (PCa) is the second most common cancer in men. Currently there is no clear understanding of preferences among oncologists in Russia in decision-making process regarding adjuvant ADT in patients with locally advanced PCa with high and very high risk of recurrence after prostatectomy or radiotherapy.
Objective: to provide accurate and reliable information regarding the adjuvant endocrine treatment in patients with locally advanced PCa in the Russian routine clinical practice.
Materials and methods. This multicentre, non-interventional, prospective observational cohort study included 204 males (mean age 64.9 ± 6.2 years) with locally advanced PCa. The patients were enrolled at 18 sites in Russian Federation. Information on the routine diagnosis-specific examinations, including PSA measurements before, after and during one year after prostatectomy / radiotherapy was collected. Information regarding patient demographics, disease characteristics, management approaches, diagnostic tests and medications received by patients was taken from the medical records.
Results. Among patients participated in the study, 64.4 % were treated surgically, and 38.6 % underwent radiotherapy; only 6 patients (4.6 %) underwent radical prostatectomy followed by radiotherapy. Median duration from diagnosis of PCa at the time of enrolment was less than 2.7 months, for 75 % of patients the disease duration did not exceed 7 months. ADT was used in 132 patients. ADT was received by 95.8 % of males treated with radiotherapy without radical prostatectomy and by 46.8 % of those who underwent radical prostatectomy without radiotherapy. Medical or surgical castration was used in 56.4 % of cases, antiandrogens without castration were used by less than 10 % of patients, while 28.2 % of patients received treatment with both castration and antiandrogens and the same number of males underwent only castration. Percentage of patients with PCa progression was 9.3 % for males after radical prostatectomy without radiotherapy and 7.4 % for those who underwent radiotherapy without radical prostatectomy. There were no cases of death due to PCa progression.
Conclusion. The results are in alignment with international guidelines and standards. Received data can help to improve management approaches for treatment of Russian patients with high risk locally advanced PCa, particularly giving a basis for a decision on use of ADT.

1. State of oncological care in Russia in 2019. Eds.: A.D. Kaprin, V.V. Starinskiy, G.V. Petrova. Moscow: MNIOI im. P.A. Gertsena - filial FGBU “NMITS radiologii” Minzdrava Rossii, 2020. 236 p. (In Russ.).

2. Bruner D.W., Moore D., Parlanti A. et al. Relative risk of prostate cancer for men with affected relatives: systematic review and meta-analysis. Int J Cancer 2003;107(5):797-803. DOI: 10.1002/ijc.11466.

3. National Cancer Intelligence Network UK, www.ncin.org.uk. Cancer Incidence and Survival by Major Ethnic Group, England, 2002-2006; 2009.

4. Catalona W.J., Smith D.S., Ratliff T.L., Basler J.W. Detection of organ-confined prostate cancer is increased through prostate-specific antigen-based screening. JAMA 1993;270(8):948-54.

5. Laurence Klotz L., Teahan S. Current role of PSA kinetics in the management of patients with prostate cancer. Eur Urol 2006;(Suppl 5):472-8.

6. Cookson M.S., Aus G., Burnett A.L. et al Variation in the definition of biochemical recurrence in patients treated for localized prostate cancer: the American Urological Association Prostate Guidelines for Localized Prostate Cancer Update Panel report and recommendations for a standard in the reporting of surgical outcomes. J Urol 2007;177(2):540-5. DOI: 10.1016/j.juro.2006.10.097.

7. Roach M. 3rd, Hanks G., Thames H. et al. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys 2006;65(4):965-74. DOI: 10.1016/j.ijrobp.2006.04.029.

8. Ministry of Health of Russia. Clinical Guidelines: Prostate cancer 2020. Available at: https://oncology-association.ru/files/clinical-guidelines-2020/rak_predstatelnoj_zhelezy.pdf. (In Russ.)].

9. Dorff T.B., Flaig T.W., Tangen C.M. et al. Adjuvant androgen deprivation for high-risk prostate cancer after radical prostatectomy: SWOG S9921 study. J Clin Oncol 2011;29(15): 2040-5. DOI: 10.1200/JCO.2010.32.2776.

10. Johansson J.E., Holmberg L., Johansson S. et al. Fifteen-year survival in prostate cancer. A prospective, population-based study in Sweden. JAMA 1997;277(6):467-71.

11. Gunner C., Gulamhusein A., Rosario D.J. The modern role of androgen deprivation therapy in the management of localised and locally advanced prostate cancer. J Clin Urol 2016;9(2 Suppl):24-9. DOI: 10.1177/2051415816654048.

12. National Institute for Health and Care Excellence (NICE). Prostate Cancer: Diagnosis and Management Clinical Guideline: NICE, 2014. Available at: https://www.nice.org.uk/guidance/cg175.

13. Lei J.H., Liu L.R., 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. DOI: 10.1038/srep07713.

14. Kumar S., Shelley M., Harrison C. et al. Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database Syst Rev 2006;(4):CD006019. DOI: 10.1002/14651858.CD006019.pub2.

15. Mottet N., Bellmunt J., Bolla M. et al. EAU-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer. Eur Urol 2017;71(4):618-29. DOI: 10.1016/j.eururo.2016.08.003.