Bayer: Science For A Better Life

United States of America

Oncology Information for Grant Submissions

Bayer Oncology Medical Affairs Department is interested in receiving and reviewing grant applications to support appropriate programs which cover the following areas of interest:

Therapeutic Areas/Disease States:

Non-metastatic Castrate Resistant Prostate Cancer (nmCRPC)

Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Intended Audience: Medical Oncologists, Urologists, Radiation Oncologists, Nuclear Medicine, Nurses, Pharmacists, Multi-disciplinary teams, Patients/Caregivers

Areas of interest based on referenced literature:

  • The role of novel anti-hormonal agents and alpha-emitting therapies in the treatment landscape in prostate cancer
  • Treatment algorithms for non-metastatic CRPC & metastatic CRPC with bone metastases
    • Appropriate sequencing of therapies from mHSPC to mCRPC
  • Understanding comorbidities, quality of survival and appropriate management of adverse events
    • Impact of treatments and adverse events on patient's daily life and quality of life
    • Impact of co-morbidities and drug-drug interactions on patients
    • Appropriate identification and management of adverse events of treatment

Proposal Requirements:

All submissions for CE/CME support must be consistent with the ACCME guidelines and contain supporting documents that should include:

  • Needs assessment
  • Educational design and rationale for selection (where applicable)
  • Learning objectives
  • Proposed faculty
  • Participant recruitment plan (where applicable)
  • Outcomes strategy/plan
  • Detailed budget (please use the template available on the website)

Provider Justification:

  • Copy of most recent accreditation letter and status
  • Sample of other program(s) in similar therapeutic areas

Process

Applications/proposals which are submitted and determined to be complete are reviewed monthly. Allow a minimum of 45 days from submission for response.

Acceptance of a BHC educational grant indicates that you will:

  • Reconcile grant funding within 60 days of completion of the educational program
  • Permit a BHC Medical Affairs representative to audit live programs
  • Share activity data and outcomes metrics within 30 days of their availability

References

Treatment landscape in prostate cancer
  1. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer, Version 4.2019 - August 19, 2019. (Link)
  2. American Cancer Society. Cancer Facts & Figures 2019. Atlanta; American Cancer Society. (Link)
  3. Gralow JR, et al. NCCN Task Force Report: Bone Health in Cancer Care. JNCCN 2013, Vol 11, S 3 (Link)
  4. Lewis B, Sartor O. Radiation-based approaches for therapy and palliation of advanced prostate cancer. Curr Opin Urol. 2012 May; 22(3):183-9. (Link)
  5. El-Amm J, Aragon-Ching JB. The Current Landscape of Treatment in Non-Metastatic Castration-Resistant Prostate Cancer. Clin Med Insights Oncol. 2019 Mar 7;13. (Link)
  6. Targeted Alpha Therapy Working Group, et al. Targeted Alpha Therapy, an Emerging Class of Cancer Agents: A Review. JAMA Oncol. 2018 Dec 1;4(12):1765-1772. (Link)
  7. Crawford ED, et al. Androgen Receptor-Targeted Treatments for Prostate Cancer: 35 Years' Progress with Antiandrogens. J Urol. 2018 Nov;200(5):956-966. (Link)
  8. Smith MR, et al. ARASENS Phase 3 Trial of Darolutamide (ODM-201) in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC). J Clin Oncol 35, 2017 (suppl; abstr TPS5092). (Link)

    nmCRPC disease state challenges and identification of appropriate patients

  9. Moilanen A et al. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep 2015;5:12007 (Link)
  10. Fizazi K, et al. Clinical Development of Darolutamide: A Novel Androgen Receptor Antagonist for the Treatment of Prostate Cancer. Clin Genitourin Cancer. 2018 Oct;16(5):332-340. (Link)
  11. Sugawara T, et al. Darolutamide is a potent androgen receptor antagonist with strong efficacy in prostate cancer models. Int J Cancer. 2019 Mar 3. (Link)
  12. Sandmann S, et al. Higher Blood–Brain Barrier Penetration of [14C]Apalutamide and [14C]Enzalutamide Compared to [14C]Darolutamide in Rats Using Whole-Body Autoradiography. J Clin Oncol 37, 2019 (suppl 7S; 156). (Link)
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  14. Olivier KM, et al. New Androgen Receptor Antagonists in Non-Metastatic Castration-Resistant Prostate Cancer. Poster Piblication, ONS Annual Meeting 2019. (Link)
  15. Tammela TL, et al. Darolutamide elicits a strong prostate-specific antigen (PSA) response in men with non-metastatic castration-resistant prostate cancer (nmCRPC): Results from the ARAMIS study. European Urology 2018, in press.
  16. Zurth, C., et al. Drug–Drug Interaction Potential of Darolutamide: In Vitro and Clinical Studies. Eur J Drug Metab Pharmacokinet. 2019 Sep 30. doi: 10.1007/s13318-019-00577-5. [Epub ahead of print] (Link)
  17. Martineau G, et al. ODENZA: A study of patient preference between ODM-201 (darolutamide) and enzalutamide in men with metastatic castrate-resistant prostate cancer (mCRPC). J Clin Oncol 37, 2019 (suppl 7S; abstr TPS334). (Link)
  18. Borgmann H, et al. Moving Towards Precision Urologic Oncology: Targeting Enzalutamide-resistant Prostate Cancer and Mutated Forms of the Androgen Receptor Using the Novel Inhibitor Darolutamide (ODM-201). Eur Urol. 2018 Jan;73(1):4-8. (Link)
  19. Shore, N et al. Evaluation of Clinically Relevant Drug–Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Targ Oncol (2019) 14: 527. (Link)
  20. Small EJ, et al. SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol 36, 2018 (suppl 4S; abstr 161). (Link)
  21. Smith MR, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med 2018; 378:1408-1418. (Link)
  22. Hussain M, et al. PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC). J Clin Oncol 36, 2018 (suppl 6S; abstr 3).(Link)
  23. Hussain M, et al. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med 2018; 378:2465-2474. (Link)
  24. Higano C. Enzalutamide, apalutamide, or darolutamide: are apples or bananas best for patients? Nat Rev Urol. 2019 Apr 30. (Link)

    Treatment algorithms for metastatic CRPC with bone metastases

  25. Parker, C., et al. (2013). Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 369(3): 213-223. (Link)
  26. Sartor O, et al. Chemotherapy following radium-223 dichloride treatment in ALSYMPCA. Prostate. 2016 Jul;76(10):905-16. (Link)
  27. Dizdarevic S. et al. Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice. Eur J Nucl Med Mol Imaging. 2019 May;46(5):1102-1110 (Link)
  28. Sartor O., et al. A Retrospective analysis of Treatment Patterns in Metastatic Castration Resistant Prostate Cancer Patients Treated with Radium-223. J Clin Oncol 37, 2019 (suppl 7S, 180). (Link)
  29. Louhanepessy RD, et al. Pain and quality of life in metastasized Castration Resistant Prostate Cancer patients treated with Radium-223 (ROTOR registry); a prospective observational registry in a non-study population. Ann. Onc., V29 (suppl_8, Oct 2018, 829P). (Link)
  30. Berthold DR, Pond GR, Soban F, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008;26:242-245. (Link)
  31. De Bono JS, Oudard S, Ozguroglu, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747): 1147-54. (Link)
  32. de Bono JS, et al. Phase III non-inferiority study of cabazitaxel (C) 20 mg/m2 (C20) versus 25 mg/m2 (C25) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (D). Clin Oncol 34, 2016 (suppl; abstr 5008). (Link)
  33. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. (Link)
  34. Suominen, MI et al. The Mode-of-Action of Targeted Alpha Therapy Radium-223 as an Enabler for Novel Combinations to Treat Patients with Bone Metastasis. Int J Mol Sci. 2019 Aug 10;20(16). pii: E3899. (Link)

    Bone health

  35. Den RB, et al. Ra-223 Treatment for Bone Metastases in Castrate-Resistant Prostate Cancer: Practical Management Issues for Patient Selection. Am J Clin Oncol. 2019 Apr;42(4):399-406. (Link)
  36. Poeppel TD, et al. Disease burden and bone health in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) in the PARABO non-interventional study. Eur Urol Suppl 2019; 18(1); e1210 (Link)
  37. Sternberg CN, et al. Use of Bone Health Agents in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Radium-223 After Abiraterone: an Interim Review of REASSURE. Ann. Onc., V29 (suppl_8, Oct 2018, 826P). (Link)
  38. Poeppel T, et al. Symptomatic Skeletal Event Dynamics in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Radium-223: an Interim Review of a Prospective, Non-interventional Study (PARABO). Ann. Onc., V29 (suppl_8, Oct 2018, 828P). (Link)
  39. Azorín-Vega E, et al. Assessment of the radiation absorbed dose produced by 177Lu-iPSMA, 225Ac-iPSMA and 223RaCl2 to prostate cancer cell nuclei in a bone microenvironment model. Appl Radiat Isot. 2019 Apr;146:66-71. (Link)
  40. Palmedo, H, et al. Pain evaluation in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) in the PARABO observation study. Annals of Oncology Volume 30, Issue Supplement_5, October 2019 (Link)
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    Appropriate sequencing and combinations of agents in mCRPC

  42. Saad F, et al. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lancet Oncol. 2016 Sep;17(9):1306-16. (Link)
  43. Maughan BL, et al. Safety data from a phase II randomized trial of radium-223 dichloride (Ra-223) plus enzalutamide (Enza) vs. Enza alone in men with metastatic castration refractory prostate cancer (mCRPC). J Clin Oncol 36, 2018 (suppl 15S; abstr 5057). (Link)
  44. Tombal BF, et al. Decreased fracture rate by mandating bone-protecting agents in the EORTC 1333/PEACE III trial comparing enzalutamide and Ra223 versus enzalutamide alone: An interim safety analysis. J Clin Oncol 37, 2019 (suppl 15S; abstr 5007). (Link)
  45. Smith M., et al. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419 (Link)
  46. Volta AD, et al. Higher Risk of Fragility Fractures in Prostate Cancer Patients Treated with Combined Radium-223 and Abiraterone: Prednisone May Be the Culprit. European Urology 2018, in press. (Link)
  47. George DS, et al. Clinical outcomes with concurrent or layered treatment with radium-223 and abiraterone plus prednisone/prednisolone: a retrospective study of real-world experience with patients with metastatic castration-resistant prostate cancer. J Clin Oncol 37, 2019 (suppl 7S, 253-253). (Link)
  48. Conteduca V, et al. Randomized, multicentre phase II trial of the sequencing of radium-223 and docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 36, 2018 (suppl 6S; abstr TPS396)(Link)
  49. Higano C, et al. Clinical Outcome with Radium-223 in Patients Previously Treated with Abiraterone or Enzalutamide: a Retrospective Study of Real-World Data from Patients with Metastatic Castration-Resistant Prostate Cancer. Ann. Onc., V29 (suppl_8, Oct 2018, 827P). (Link)
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  51. Godwin JL, et al. c15-162: Phase IB trial of radium 223 and niraparib in patients with castrate resistant prostate cancer (NiraRad). J Clin Oncol 36, 2018 (suppl 6S; abstr TPS385) (Link)
  52. O’Sullivan, JM, et al. Radium-223 Within the Evolving Treatment Options for Metastatic Castration-resistant Prostate Cancer: Recommendations from a European Expert Working Group. European Urology 2018, in press. (Link)
  53. Khalaf D, et al. Phase 2 randomized cross-over trial of abiraterone + prednisone (ABI+P) vs enzalutamide (ENZ) for patients (pts) with metastatic castration resistant prostate cancer (mCPRC): Results for 2nd-line therapy. J Clin Oncol 36, 2018 (suppl; abstr 5015) (Link)
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