Clinical impact of type I and type II 5 alpha-reductase inhibition in prostatic disease: review and update 아주대학교김선일

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1 Clinical impact of type I and type II 5 alpha-reductase inhibition in prostatic disease: review and update 아주대학교김선일

2 Development of 5ARI Discovery of 5AR type I and type II Pharmacodynamic and pharmacokinetic characteristics of dutasteride and finasteride Dutasteride vs finasteride: clinical results in BPH Dutasteride in prostate cancer Clinical safety

3 Development of 5ARI Discovery of 5AR type I and type II Pharmacodynamic and pharmacokinetic characteristics of dutasteride and finasteride Dutasteride vs finasteride: clinical results in BPH Dutasteride in prostate cancer Clinical safety

4 Role of DHT in prostate Description of 5AR deficiency syndrome in 1974 Unable to metabolize T to DHT Male with ambiguous genitalia, microphallus, underdeveloped prostate etc. Masculinization at puberty, but prostate remains underdeveloped DHT is the active androgen modulating prostate growth

5 Effect of testosterone in prostatic epithelial cell T Stromal cell Epithelial cell T T 5α Red DHT + AR DNA T mrna T Metabolic Effects Protein Secretion

6 Development of 5ARI Idea: inhibition of 5AR achieve therapeutic effect of castration without losing maleness First 5ARI, 4-methyl-4-aza-steroid (4MA) developed in 1981 Liang et al. J Biol Chem 1981;256:7998 4MA effect against human PC tissue and rat PC investigated Kadohama et al. Cancer Res 1984;44:4947 Kadohama et al. J Natl Cancer Inst 1985;74:475 Development of MK-906 (finasteride) in 1984

7 Development of 5ARI Discovery of 5AR type I and type II Pharmacodynamic and pharmacokinetic characteristics of dutasteride and finasteride Dutasteride vs finasteride: clinical results in BPH Dutasteride in prostate cancer Clinical safety

8 Discovery of 5AR isozymes 5ARI type 1 Neutral to basic ph Weakly inhibited by finasteride Liver and skin Not mutated in 5AR deficiency patients 5ARI type 2 Acidic ph Sensitive to finasteride Genital tissue and liver Mutated in 5AR deficiency patients Russel et al. Ann Rev Biochem 1994;63:25

9 Increased Expression of 5AR1 and 5AR2 in BPH Both 5AR1 and 5AR2 mrna levels are higher in BPH tissue vs. normal prostate tissue 5ARI/TBP mrna AR2/TBP mrna PZ (n=6) TZ (n=9) CZ (n=4) BPH (n=17) PCa (n=10) 0 PZ (n=6) TZ (n=9) CZ (n=4) BPH (n=17) PCa (n=10) Normal prostate Normal prostate Iehle et al. J Steroid Biochem Molec Biol 1999;68:189 95

10 Development of 5ARI Discovery of 5AR type I and type II Pharmacodynamic and pharmacokinetic characteristics of dutasteride and finasteride Dutasteride vs finasteride: clinical results in BPH Dutasteride in prostate cancer Clinical safety

11 Pharmacodynamic and pharmacokinetic characteristics of dutasteride and finasteride inhibitor species Serum halflife Inhibitor potency (IC50), nmol/l SRD5A1 isoform SRD5A2 isoform Finasteride Rat 2 h 5.4 ± ± 0.1 Human 6 h 360 ± ± 1 Dutasteride Rat 31 h 0.3 ± ± 0.04 Human > 3 d 6 ± 1 7 ± 3 Xu et al. Clin Cancer Res 2006;12:4072

12 5α-Reductase Inhibitors: Comparison of Physiologic Effects Physiologic Effect 5AR inhibition Serum DHT Finasteride Type II ~70% Dutasteride Type I and II >90% Serum T Serum PSA 14%-20% Total PSA ~50%; Free PSA ~50% F/T ratio unchanged Serum half-life Dosage 6-8 hours 5 mg od 5 weeks 0.5 mg od Bartsch G et al. In: Chatelain C et al, eds. Benign Prostatic Hyperplasia. Plymouth, UK: Health Publication Ltd; 2001: Roehrborn CG et al. Urology. 2002;60:

13 Proportion of patients experiencing a 70% or 90% reduction in serum DHT at 24 weeks Proportion of patients (%) % 90% Percentage reductions in serum DHT Dutasteride 0.5 mg/day Finasteride 5.0 mg/day Clark et al. J Clin Endocrin Metab 2004;89:2179

14 Effect of Dutasteride on Intraprostatic DHT: ARI40014 Study Double-blind, placebo-controlled trial: BPH patients randomised to receive Dutasteride 0.5 mg or placebo for 3 months prior to TURP % difference compared with placebo Serum Tissue ARI40014; Data on file

15 Development of 5ARI Discovery of 5AR type I and type II Pharmacodynamic and pharmacokinetic characteristics of dutasteride and finasteride Dutasteride vs finasteride: clinical results in BPH Dutasteride in prostate cancer Clinical safety

16 Clinical Efficacy (BPH Monotherapy): Outline EPICS: direct comparison of dutasteride and finasteride Direct comparison of onset of symptomatic benefit Indirect comparison of Phase III trials: Serum DHT suppression PV Q max AUA-SI Risk of AUR and surgery

17 Enlarged Prostate International Comparator Study (EPICS): Design A trial directly comparing dutasteride with finasteride A multi-centre, randomized, double-blind, active-controlled study A total of 1630 BPH patients were randomized to receive dutasteride, 0.5 mg/day (n=813) or finasteride, 5 mg/day (n=817) for 12 months Primary endpoint: PV (measured by TRUS) Secondary endpoints: AUA-SI, Q max GSK Clinical Trial Register

18 EPICS: Reduction in PV months 12 months Dutasteride Finasteride No statistically significant difference at any time point -30 Mean reduction in PV from baseline GSK Clinical Trial Register

19 EPICS: Increase in Q max Mean change in Q max from baseline (ml/s) Dutasteride Finasteride months 6 months 12 months GSK Clinical Trial Register No statistically significant difference at any time point

20 EPICS: Reduction in AUA-SI GSK Clinical Trial Register 3 months 6 months 12 months -7.0 Mean point reduction in AUA-SI score from baseline Dutasteride Finasteride No statistically significant difference at any time point

21 Onset of Symptom Relief with Dutasteride and Finasteride: A Direct Comparison A prospective, observational study Men with benign prostatic enlargement (PV > 30 cc prescribed either finasteride 5 mg/day or dutasteride 0.5 mg/day AUA-SI score recorded at baseline and at 3 months Primary outcome: difference in the proportion of patients who had an improvement in AUA-SI from baseline at 3 months in the two study groups Hagerty et al. J Am Osteopath Assoc Submitted

22 Proportion of patients (%) p= % 30% 23.3% 18.3% Dutasteride (n=120) Finasteride (n=120) 10 0 Any improvement 11.7% 4.2% 0.8% 1.7% 1 point 2 points 3 points Change in AUA-SI score Hagerty et al. J Am Osteopath Assoc. Submitted

23 Phase III BPH Studies: Design Study duration Design Subjects Primary endpoints Secondary endpoints Dutasteride PIII trials 1,2 4 years 2-year, randomized, double-blind, placebo-controlled 2-year open label (OL) Active = 2167 (1188 into OL) Placebo = 2158 (1152 into OL) Changes in AUA-SI and the risk of AUR Changes in: TPV, Q max, surgical intervention, PSA, T, and DHT Safety and tolerability Finasteride PLESS 3 4 years Randomized, doubleblind, placebo-controlled Active = 1524 Placebo = 1516 Modified AUA-SI Surgery for BPH and the occurrence of AUR 1 Roehrborn et al. Urology 2002:60; Roehrborn et al. Urology 2004:63; McConnell et al. N Engl J Med 1998;338:557 63

24 Serum DHT Suppression at 4 years 0% -20% -40% -60% -80% -70% -100% -95.3% -120% % reduction in DHT at 4 years Dutasteride Finasteride Debruyne et al. Eur Urol 2004:46; McConnell et al. N Engl J Med 1998;338: Indirect comparison of Dutasteride 4-year data vs. PLESS

25 PV Reduction at 4 years 0% -5% -10% -15% -20% -18% -25% 27.3% -30% % reduction in PV at 4 years Dutasteride Finasteride Debruyne et al. Eur Urol 2004:46; McConnell et al. N Engl J Med 1998;338: Indirect comparison of Dutasteride 4-year data vs. PLESS

26 Improvement in Q max at 4 years Increase in Q max at 4 years (ml/sec) Dutasteride Finasteride Debruyne et al. Eur Urol 2004:46; McConnell et al. N Engl J Med 1998;338: Indirect comparison of Dutasteride 4-year data vs. PLESS

27 Improvement in AUA-SI Score at 4 years Change in AUA-SI score at 4 years Dutasteride Finasteride Debruyne et al. Eur Urol 2004:46; McConnell et al. N Engl J Med 1998;338: Indirect comparison of Dutasteride 4-year data vs. PLESS

28 PLESS Duta phase III Placebo Dutasteride Double blind Open label

29 Summary of indirect comparison Reduction in PV, % Increase in Q max, ml/s Reduction in AUA-SI score, points Reduction in AUR, % Reduction in surgery, % Dutasteride (Phase III) 1, (2-yr) 27.3 (4-yr) 2.2 (2-yr) 2.7 (4-yr) 4.4 (2-yr) 6.5 (4-yr) 57 (2-yr) 48 (2-yr) Finasteride (4-year, PLESS) (4-yr) 55 (4-yr) 1 Debruyne et al. Eur Urol 2004:46; Roehrborn et al. Urology 2004:63; McConnell et al. N Engl J Med 1998;338: Indirect comparison of Dutasteride 2- and 4-year data vs. PLESS

30 Clinical Efficacy (Combination therapy)

31 Finasteride Alpha-Blocker Withdrawal Study: Key Results Proportion of patients in whom discontinuation was successful * % of patients mg/day 4 mg/day 8 mg/day mo. 6 mo. 9 mo. 12 mo. Time of discontinuation Baldwin et al. Urology 2001;58(2):203 8 * Successful discontinuation defined by no increase in AUA-SI score and no desire to restart doxazosin

32 SMART-1: Key Results Proportion of patients who reported feeling the same or better at Week 30 vs. Week 24 % of patients Majority of Patients Felt the Same or Better After Discontinuation of Tamsulosin Therapy 91% 77% 0 Dutasteride + Tamsulosin for 36 weeks Treatment groups Dutasteride + Tamsulosin for 24 weeks Dutasteride + matching placebo for 12 weeks Barkin et al. Eur Urol 2003;44:461 66

33 SMART-1: Key Results % patients Patients Continued to Feel the Same or Better 12 Weeks After Discontinuation Proportion of patients reporting to feel the same or better at Week 36 vs. Week 24* 96% 93% Dutasteride + Tamsulosin for 36 weeks Treatment groups Dutasteride + Tamsulosin for 24 weeks Dutasteride + matching placebo for 12 weeks * Of the patients who reported to feel the same or better at Week 30 Barkin et al. Eur Urol 2003;44:461 66

34 Development of 5ARI Discovery of 5AR type I and type II Pharmacodynamic and pharmacokinetic characteristics of dutasteride and finasteride Dutasteride vs finasteride: clinical results in BPH Dutasteride in prostate cancer Clinical safety

35 5ARI and PC 5ARI 4MA inhibit growth of PC-82 and PR-129 in implanted animals Andriole et al. Prostate 1987;10:419 Kadohama et al. JNCI 1985;74:475 Several potential use of finasteride against PC suggested 1. Single-agent therapy 2. Combination therapy with other androgen blocking agents 3. Prevention of PC Gormley. Urol Clin North Am 1991;18:93

36 Finasteride monotherapy against PC Randomized placebo-controlled trial with finasteride on stage D PC patients PSA decrease at 3 and 6 months of 22.9% and 15.1% from baseline Only minor effect in spite of potency preservation and low toxicity Presti et al. J Urol 1992;148:1201

37 Finasteride monotherapy against PC Finasteride 10mg or placebo in nonmetastatic PC patients following RRP for 12 M followed by open label 12 M (total 24 M) Delay PSA increase by 9 M Reduced local and distant recurrence compared to control Poor response compared to castration in recurred cases Andriole et al. Urology 1995;45:491

38 PC prevention by finasteride PCPT 5mg finasteride daily Started Oct 1993 & closed enrollment Dec 1996, 18,882 participants Published % reduction in PC incidence during 7 years Increase in high grade tumor incidence

39 Distribution of 5AR type 1 & type 2 in prostate and PC 5AR type 1 activity, mrna in LNCaP cells and BPH tissue, 5AR type 2 only in BPH Negri-Cesi et al. Prostate 1998;34:283 5AR type 1 mrna expression higher in PC tissue than normal or hyperplastic prostate; type 2: not different Iehlé et al. J Steroid Biochem Mol Biol 1999;68:189 5AR type 1 immunostaining is increased and type 2 decreased during development of PC Increased expression of both 5AR in recurrent and metastatic cancers Thomas et al. Prostate 2005;63:231

40 Increased Expression of 5AR1 in PC, but not 5AR2 5ARI/TBP mrna AR2/TBP mrna PZ (n=6) TZ (n=9) CZ (n=4) BPH (n=17) PCa (n=10) 0 PZ (n=6) TZ (n=9) CZ (n=4) BPH (n=17) PCa (n=10) Normal prostate Normal prostate Iehle et al. J Steroid Biochem Molec Biol 1999;68:189 95

41 Increased Expression of 5AR1 and 5AR2 in Advanced PCa In advanced PCa, the expression of both 5AR isoenzymes increases Mean area of moderate to high intensity staining (% of total epithelial/tumour area) BPH PIN Primary PCa Recurrent PCa PCa metastases * 5AR1 *Significantly different from BPH Significantly different from PIN, Primary PCa Significantly different from Recurrent PCa * * * * 5AR2 Thomas et al. Prostate 2005;63(3):231 39

42 Proposed reasons for limited effect of finasteride against PC 5AR type 2 specific: IC 50 for type 2: 69nmol/L; IC 50 for type 1: 360nmol/L At 5 or 10mg, max. serum level <200nmol/L (<IC 50 for type 1) Short serum half-life (6h) 82% binding to serum proteins Down regulation of 5AR type 2, while maintenance or enhancing of type 1 in human PC

43 Dutasteride against PC: in vitro Dutasteride inhibits androgen action and promotes cell death in the LNCaP PC cell line Lazier et al. Prostate 2004;58:130 Dutasteride induces apoptosis in androgen-sensitive PwR-1E, PNT-2, LNCaP cell lines and in androgen receptor-expressing PC3 cell line McCrohan et al. Cancer 2006;106:2743

44 Dutasteride against PC: animal study In animal models, Dutasteride provided greater DHT suppression and greater inhibition of tumour growth than finasteride Tumour volume (cc) Days following start of therapy Intact vehicle Castrate vehicle Finasteride 0.72 mg/kg/day Finasteride 7.2 mg/kg/day Finasteride 72 mg/kg/day Dutasteride 1 mg/kg/day Dutasteride 10 mg/kg/day Dutasteride 100 mg/kg/day Xu et al. Clin Cancer Res 2006;12:4072

45 Dutasteride against PC: clinical study A multi-centre, randomized, double-blind, placebocontrolled, parallel-group study: effects of dutasteride (0.5 mg and 3.5 mg daily) for 4 months before radical prostatectomy in men with clinically localized PCa Median total tumor volume Median tumour volume (cc) was 40% lower in men 2.5 treated with dutasteride vs placebo (p=ns) Gleave et al. Prostate 2006;66: Placebo Dutasteride 0.5 mg Dutasteride 3.5 mg

46 Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial 4-year, international, multicenter, randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of oral, once daily 0.5mg dutasteride in men at increased risk for prostate cancer Approx. 650 centers Prim. end point: biopsy detectable PC after 2 and 4 years Underway Andriole et al. J Urol 2004;172:1314

47 Comparison of REDUCE and PCPT Study Duration No. of subjects Location Baseline biopsies Follow-up biopsies PSA entry criteria (ng/ml) Age (years) Enzymes inhibited Significance PCPT 1 7 years 18,882 USA only No 7 years 3.0 >55 5AR2 Prevention REDUCE 2 4 years ~ 8000 International Yes (1 neg biopsy within 6 M of enrolment) 2 and 4 years >50 5AR1 and 5AR2 Prevention and early treatment 1 Thompson et al. N Engl J Med 2003;349(3): Andriole et al. J Urol 2004;172:1314 7

48 Development of 5ARI Discovery of 5AR type I and type II Pharmacodynamic and pharmacokinetic characteristics of dutasteride and finasteride Dutasteride vs finasteride: clinical results in BPH Dutasteride in prostate cancer Clinical safety

49 EPICS: Direct Comparison of Adverse Events Any adverse event Any sexual event Impotence Decreased libido Ejaculatory disorder Gynaecomastia Dutasteride 0.5 mg n = % 11% 7% 5% 1% 1% Finasteride 5 mg n = % 14% 8% 6% 1% 1% Andriole et al. Eur Urol 2003;44:82 8 Nickel Rev Urol 2004;6(Supp.9):S31 9

50 Indirect Comparison of Sexual Adverse Events Drug-Related Sexual Adverse Events Impotence Decreased libido Ejaculatory disorder Gynaecomastia* Pivotal, 2 years % Dutasteride patients (% placebo patients) 6.0 (3.0) 3.7 (1.9) 1.8 (0.7) 1.3 (0.5) PLESS, 1 year % finasteride patients (% placebo patients) 8.1 (3.7) 6.4 (3.4) 3.7 (0.8) 0.9 (0.2) *Includes breast enlargement and breast/nipple tenderness (reported separately in PLESS) Nickel Rev Urol 2004;6(Supp.9):S31 9

51 Conclusion Dutasteride is more potent at inhibiting both 5AR1 and 5AR2 vs finasteride with similar side effects. Dutasteride provides greater serum DHT suppression intraprostatic DHT suppression than finasteride. Dutasteride provided similar clinical efficacy with finasteride at short term in terms of reduction in PV, improvements in Q max and reduction of symptom scores. Results of REDUCE trial will clarify the applicability of dutasteride for the prevention and early treatment of prostate cancer.

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