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"Creating a Prostate Cancer Center of Excellence"

"Creating a Prostate Cancer Center of Excellence". Paul Sieber MD FACS Lancaster Urology. ADT Clinic. Why 1. Consistency of care 2. Improved outcomes 3. Better economics What does it take 1. Discipline 2. Mid-level providers

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"Creating a Prostate Cancer Center of Excellence"

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  1. "Creating a Prostate Cancer Center of Excellence" Paul Sieber MD FACS Lancaster Urology

  2. ADT Clinic • Why 1. Consistency of care 2. Improved outcomes 3. Better economics • What does it take 1. Discipline 2. Mid-level providers 3. Planning • Who cares 1. Insurers 2. Patients • How 1. Implementation

  3. Bone Clinic

  4. Journal of UrologyFebruary 1997 Osteoporosis after Orchiectomy for Prostate Cancer Harry W Daniell UC Davis, Department of Family Practice First article attributing orchiectomy with accelerated osteoporosis and questions risks to long term survivors.

  5. ADT and Fracture Risk

  6. ADT Is Associated With Fracture ADT-Related Fracture-Free Survival • In men surviving at least 5 years after diagnosis: • Of those receiving ADT, 19.4% experienced a fracture • Of those NOT receiving ADT, 12.6% experienced a fracture • ADT resulted in an excess risk of fracture of 45% 100 90 80 70 60 Unadjusted Fracture-Free Survival (%) 50 40 No ADT (n = 32,931)GnRH agonist, 1–4 doses (n = 3763)GnRH agonist, 5–8 doses (n = 2171)GnRH agonist, ≥ 9 doses (n = 5061)Orchiectomy (n = 3399) 30 20 10 0 1 2 3 4 5 6 7 8 9 10 Years After Diagnosis ShahinianVB, et al. N Engl J Med. 2005;352:154-164.

  7. Fractures in Men Receiving ADT and Survival 1.0 0.9 0.8 0.7 0.6 Cumulative Proportion Surviving 0.5 0.4 History of fracture (n = 24) No history of fracture(n = 171) P = 0.04 0.3 0.2 0.1 0 20 40 60 80 100 120 140 160 180 200 Months • In men receiving ADT for prostate cancer, median overall survival was reduced in those who sustained a skeletal fracture since diagnosis of prostate cancer (121 vs 160 months, P = 0.04) • Skeletal fracture was a negative predictor of survival (Relative Death Risk = 7.4, P = 0.007) Oefelein MG, et al. J Urol. 2002:168:1005-1007; Department of Health and Human Services. A report of the Surgeon General. 2004.

  8. Bone Clinic Protocol • 1. All patients on ADT seen by mid-level at least yearly • 2. All patients undergo DEXA • 3. All patients have metabolic studies • 4 All patients assessed/counseled for risk: FRAX,fall,glasses,smoking,EtOHconsumption,calcium/vitamin D

  9. Screening for Bone Loss • DXA(Dual X-ray Absorptiometry) = Gold Standard • Total hip, femoral neck and lumbar spine standard areas of interest • Heel ultrasound, finger or forearm DXA, and quantitative CT other options but numerous weaknesses

  10. Metabolic workup • CMP, CBC, Vitamin D minimum • Stone formers 24 hour urine • Options; TSH, evaluate for GI malabsorption, Endocrine consult

  11. TREATMENT DECISION • 2 clinical trials with level 1 evidence of both BMD and fracture reduction • Patient population included men< 70 with osteopenia and >70 without regard to BMD • NOF recommends treat osteoporosis follow FRAX for others • What is risk level for osteopenics on ADT

  12. BMD vs Fracture Rate & Incidence BMD

  13. Minimum treatment • Ensure adequate calcium/vitamin D intake 1200/800 • Vitamin D >30 • Reduce alcohol, smoking cessation, and weight bearing exercises • Fall reduction strategies

  14. Pharmacologic Therapy • 1. Prolia-RANK ligand monoclonal antibody • 2. Aledronate(Fosamax).Risedronate(Actonel) • 2. Zoledronic acid(Zometa,Reclast) • 2.Raloxifene(Evista) • 3.? Teriparatide(Forteo) blackbox warning with radiation therapy • 3. Calcitonin(Miacalcin) no data in men

  15. Clinical Impact of Low Testosterone Levels: Two Peer-Reviewed Articles Morote et al – Urology. 2007 Perachino et al – BJUI. 2009

  16. Testosterone Escapes OccurFrequently During LHRH Agonist Therapy Serum testosterone Adapted from Morote J et al.J Urol. 2007;178:1290–5

  17. Survival-Free of AIP According toSerum Testosterone Behavior Testosterone increases Group 1: <20 ng/dL Group 2: 20–50 ng/dL Group 3: >50 ng/dL 1.0 P=0.0207 0.8 Group 1 (106 months) 0.6 Cumulative survival free of PSA progression Group 2 (90 months) 0.4 Group 3 (72 months) 0.2 0.0 AIP, androgen-independent progression 0 24 48 72 96 120 144 168 192 216 240 Months under ADT Adapted from Morote J et al. J Urol. 2007;178:1290–5

  18. Higher 6-Month Testosterone Levels Increase Risk of Death by 1.33 Times Predictors of survival probability (Cox regression model) Goserelin 10.8 mg every 3 months; bone-only prostate cancer patients (N=117) SEM, standard error of the mean; Ln, natural logarithm Perachino M et al.B J U Int2010; 105(5); 648-51

  19. Bone Clinic ADT Clinic

  20. Urologists Provided Most Overall Healthcare Services to Patients with Prostate Cancer Over the Course of Disease Progression • Initial care: first 12 months after diagnosis • Continuing care: between initial and end of life • End of life care: final 12 months of life † % Prostate Cancer Health Services End of Life Care Initial Care Overall Care Continuing Care *Medical oncology and hematology/oncology †Internal medicine, family practice and general practice Skolarus 2010 J Urol 184:2279-2284

  21. Natural History of Prostate Cancer Under the care of ONCOLOGIST Androgen Deprivation Chemotherapy Death Therapies After LHRH Agonists and Antiandrogen Local Therapy Post Chemo Asymptomatic Symptomatic Non Metastatic Metastatic Castration Sensitive Castration Resistant • Typical presentation of patients as they move through the different stages. The line represents level burden of disease. Time is not proportional Abbreviation: LHRH=luteinizing hormone-releasing hormone.

  22. New Paradigms 1.Bone Agents Xgeva ?Radium 223 2. Provenge 3. Abiraterone 4. Enzulutamide

  23. Metastatic Disease • Detection of previously unidentified metastatic disease as a leading cause of screening failure in a phase III trial of zibotentan versus placebo in patients with nonmetastatic, castration resistant prostate cancer. • Yu EY J Urol July 2012 • 31% of men with apparent M0 disease were M1

  24. Bone Metastasis • Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Smith MR et al Lancet Jan 2012 396 23% of men with apparent MO disease were M1

  25. Provenge Survival Chodak G ASCO 2012 Abstract 4648

  26. Prior SRE Associated with Greater Risk of Subsequent SRE Saad F Clin GU Cancer 5:390-6

  27. ADT Clinic • Bone Clinic plus 1. ROS for side effects 2. Additional labs include annual CBC,CMP,HgbA1c,Lipid profile 3. PSA doubling time if appropriate 4. Update to PCP

  28. Keys to Success • Physician champion • Motivated mid-level as well • Group Buy-in • Make it easy for group members

  29. William Penn “Liberty without discipline equals chaos Discipline without liberty equals slavery”

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