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Locally advanced prostate cancer – the Scandinavian experience

This article explores the incidence, mortality, and treatment outcomes of locally advanced prostate cancer in Sweden, with a focus on randomized trials and population-based register studies. It discusses the use of anti-androgen therapy, radiotherapy, and hormone therapy in different stages of the disease. The study also evaluates the impact of these treatments on overall survival and quality of life in patients.

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Locally advanced prostate cancer – the Scandinavian experience

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  1. Locally advanced prostate cancer – the Scandinavian experience G Ahlgren M.D. Ph.D. Dept of Urology Skåne University Hospital Sweden

  2. Incidence and mortality from prostate cancer in Sweden 1970-2012

  3. Stage at diagnosis – NPCR data 2011 Regional mets Locally advanced

  4. Cumulative death from prostate cancer in high risk and regional metastatic disease 15 years from diagosis in sweden All ages <65 years age 65-75 age>75 Other CVD PCa Other CVD PCa NPCR 2012

  5. GS <7 GS 7 GS 8-10 Survival Outcomes in T3/T4 Cancers; age and Gleason Score Age <65 Age 65-75 Age 75-84 Age >85 Akre O et al. Eur Urol. 2011 Sep;60(3):554-63

  6. NPCR data; Treatment of different stages <75 years 2007-2012 Regional metastatic S RT HT Locally advanced S RT HT

  7. Scandinavian studies to prove treatment efficacy in high risk locally advanced PCa • Randomized trials, • SPCG 4 (T2) • SPCG 7 • SPCG 12 • SPCG 13 • Population based Register studies (NPCR) • SPCG 15

  8. SPCG 4; CSS 18years FU 11% absolute RR 44% relative RR

  9. SPCG 4; CSS 18years FU 11% absolute RR 44% relative RR

  10. Randomization: SPCG VII Neo-adj. TAB 3 months Cont: Anti-Androgen AA alone R Neo-adj. TAB1 3 months RAD (Prostate, Ves.sem) Cont: Anti-androgen AA+RAD Primary aim: 10% absolute reduction of PCa specific mortality by AA+RAD2 1EulexinR 250 mg x 3/day + Procren DepotR/11.25/3 mth; 2 70-74 GY Fosså, abstract ASCOGU symposium 2014

  11. Baseline characteristics 1Unknown: 1%; 2Gleason score: ~6; 3Gleason score: 7; 4Gleason score: ≥8 Fosså, abstract ASCOGU symposium 2014

  12. Cumulative Incidence (%) of Mortality Overall Mortality PCa Specific Mortality 35% vs 26% 57% vs 43% 19% vs 8% 31% vs 12% AA AA AA+RAD AA+RAD Fosså, abstract ASCOGU symposium 2014

  13. Cumulative Incidence (%) of Mortality(95% Confidence Interval)Main endpoint: Prostate Cancer specific survival Difference between Relative Risk: 1p: 0.00004; 2p: 0.0006 Fosså, abstract ASCOGU symposium 2014

  14. Discussion: Published ~10year 0verall Survival* A: RAD vs RAD+ ADT B: HORM vs RAD+Horm 7yr 8yr 66 65 74 74 54 49 60 49 40 39 ADT AA Hanks 2003 *Locally advanced/ high-risk PCa only (clinically staged) A-B: Randomized trials C: Retrospective observational studies C: PROSTATECTOMY 71 83 58 80 60 High risk Very High risk Joniau 2012 Fosså, abstract ASCOGU symposium 2014

  15. Adverse effects (Bother): 4 years FOLLOW-UP Bother:0: min 10: max ; Qol: 0 worst 10: best Sexual Bother Urinary Bother Bowel Bother Quality of Life ( QoL) Fosså, abstract ASCOGU symposium 2014 Fransson, Lancet Oncol, 2009

  16. Ad Pro – SPCG 12 Study start RAD PROSTECTOMY RANDOM I S AT I ON Docetaxel 75 mg/m2 i.v. q 3 w x 6 End point PSA>0,5 ng/ml In 2 samples one week apart Hormone and RT aloud when end point is reached High Risk patients Surveillance until end-point is reached Estimated number of patients; 396

  17. Principal Investigators – study boardAdPro / SPCG 12Urology Oncology Dr Göran Ahlgren (Sweden, Coordinating investigator) Prof Tuevo Tamela (Finland) Dr. Anders Angelsen (Norway) Dr. Michael Borre (Denmark) Eirikur Jonson (Island) Dr. Per Flodgren (Sweden) Prof. Pirkko Kellokumpu-Lehtinen (Finland) Dr. Jon R Iversen (Norway) Dr. Lise Sengelov (Denmark) Ásgerdur Sverrisdottir (Island) 27 sites in all the 5 Nordic countries

  18. Inclusion criteria • Men > 18 and ≤70 years of age. • WHO/ECOG performance status 0 – 1. • Histological proven adenocarcinoma of the prostate. • One of the following: • pT2 with Gleason score 4+3 or 8–10 and positive margins in the radical prostatectomy specimen or • any pT3a tumour with Gleason score 4+3 or higher or • any grade 4 tumor with pT3b. • Any N+ tumor if Gleason grade 4 or higher (pT2-3) • If pre-operative PSA  10.0 ng/ml, lymph node dissection should be performed but is not mandatory. • Post-operative PSA ≤ 0.5 ng/ml. • Negative bone scan prior to study start.

  19. SPCG 12; Final recruitment 2010-05-31459 patients In May 2014 all patients have 4 years FU

  20. Baseline data;PSA at randomization PSA at Radical Prostatectomy

  21. pT-stage – all randomized patients Assumed in the protocol 20/80% pT2/pT3

  22. Primary and secondary Gleason grade in rp-specimen Surveillance arm (%) 37,4% Gleason 8-10!!

  23. Performance status in Arm A and B Docetaxel Surveillance

  24. Kaplan-Meier curve on progression in the surveillance arm (mean 4.4 years FU)

  25. Key Inclusion Criteria • > 18 and ≤ 75 Years of age • Radical radiotherapy for prostate cancer • WHO/ECOG performance status 0-1 • Histologically/ proven adenocarcinoma Prostate Cancer within 9 mths • One of the following ∙ T2 with Gleason score (4+3) and PSA >10ug/l ∙ T2 with Gleason 8-10, any PSA ∙ any T3 tumour • Prior neoadjuvant hormone therapy is mandatory • Laboratory values within certain limits • Written informed consent

  26. SPCG 13; Trial Design • The study is an open, multinational, multi-center, randomised phase III study • Patients who have had a radical radiotherapy for prostate cancer and have an intermediate or high risk of recurrence, according to the criteria inclusion criteria

  27. Are the cohorts for RP and RT comparable?

  28. Conclusions • Surgery better than WW in low-intermediate risk Pca • RT+HT better than HT alone in locally advanced disease • Surgery better than RT if all cancer can be removed? • RT better or equal in locally advanced disease? • Results from adjuvant chemotherapy studies will tell if there is a role!

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