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: Oncologists, Urologists, Radiation Oncologists, Nuclear Medicine, Community HCPs, Nurses, Pharmacists, 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 advanced prostate cancer
- 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(required on a quarterly basis)
- Detailed budget
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
- NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer, Version 4.2019 - August 19, 2019. (Link)
- American Cancer Society. Cancer Facts & Figures 2019. Atlanta; American Cancer Society. (Link)
- Gralow JR, et al. NCCN Task Force Report: Bone Health in Cancer Care. JNCCN 2013, Vol 11, S 3 (Link)
- 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)
- 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)
- 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)
- 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)
- 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
- 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)
- 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)
- 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)
- 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)
- Fizazi K, et al. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. (Link)
- Olivier KM, et al. New Androgen Receptor Antagonists in Non-Metastatic Castration-Resistant Prostate Cancer. Poster Piblication, ONS Annual Meeting 2019. (Link)
- 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.
- 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)
- 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)
- 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)
- 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)
- 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)
- Smith MR, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med 2018; 378:1408-1418. (Link)
- 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)
- Hussain M, et al. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med 2018; 378:2465-2474. (Link)
- 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
- Parker, C., et al. (2013). Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 369(3): 213-223. (Link)
- Sartor O, et al. Chemotherapy following radium-223 dichloride treatment in ALSYMPCA. Prostate. 2016 Jul;76(10):905-16. (Link)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Tablazon IL et al. Predictors of skeletal-related events and mortality in men with metastatic, castration-resistant prostate cancer: Results from the Shared Equal Access Regional Cancer Hospital (SEARCH) database. Cancer. 2019 Aug 7. [Epub ahead of print] (Link)
Appropriate sequencing and combinations of agents in mCRPC
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Miller K, et al. Radium-223 Therapy After Abiraterone: Analysis of Symptomatic Skeletal Events in an International Early Access Program in Patients With Metastatic Castration-Resistant Prostate Cancer. Ann. Onc., V29 (suppl_8, Oct 2018, 824P). (Link)
- 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)
- 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)
- 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)
- Matsubara N, et al. Abiraterone Followed by Enzalutamide Versus Enzalutamide Followed by Abiraterone in Chemotherapy-naive Patients With Metastatic Castration-resistant Prostate Cancer. Clinical Genitourinary Cancer 2018, 16 (2), 142-148 (Link)
- Azad AA, et al. Efficacy of Enzalutamide Following Abiraterone Acetate in Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer Patients. European Urology 2015, 67 (1), 23-29 (Link)
- Bryce AH, et al. Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL. Prostate Cancer and Prostatic Diseases (2017) 20, 221–227(Link)
- Sartor, O et al. Re‐treatment with radium‐223: 2‐year follow‐up from an international, open‐label, phase 1/2 study in patients with castration‐resistant prostate cancer and bone metastases. Prostate. 2019 Oct;79(14):1683-1691. (Link)