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Thursday, February 8, 2018, San Francisco, California, 6:45 PM – 8:45 PM (Pacific Time)

Beyond the Guidelines: Investigator Perspectives on Current Clinical Issues and Ongoing Research in the Systemic Treatment of Prostate Cancer

Event Details

Location:
San Francisco Marriott Marquis
780 Mission Street
San Francisco, CA 94103
Hotel Phone: (415) 896-1600

Time:
6:15 PM – 6:45 PM (Pacific Time) — Registration and Buffet Dinner
6:45 PM – 8:45 PM (Pacific Time) — Educational Program

Meeting Room:
Yerba Buena Ballroom, Salon 9-15 (Lower B2 Level)

There is no registration fee for this event. However, preregistration is advised as seating is limited.

Faculty:
Robert Dreicer, MD, MS
Section Head, Medical Oncology
Deputy Director
University of Virginia Cancer Center
Associate Director for Clinical Research
Co-Director
Paul Mellon Urologic Cancer Institute
Professor of Medicine and Urology
University of Virginia School of Medicine
Charlottesville, Virginia

Karim Fizazi, MD, PhD 
Head of the Department of Cancer Medicine
Institute Gustave Roussy
Professor in Oncology
University of Paris
Villejuif, France

Daniel P Petrylak, MD
Professor of Medicine
Director, Prostate and GU Medical Oncology
Co-Director, Signal Transduction Program
Yale Cancer Center
New Haven, Connecticut

A Oliver Sartor, MD
CE and Bernadine Laborde
Professor for Cancer Research
Medical Director, Tulane Cancer Center
Assistant Dean for Oncology
Tulane Medical School
New Orleans, Louisiana

Mary-Ellen Taplin, MD
Chair, Executive Committee for Clinical Research
Director of Clinical Research
Lank Center for Genitourinary Oncology
Institute Physician
Professor of Medicine, Harvard Medical School
Dana-Farber Cancer Institute
Boston, Massachusetts

Moderator:
Neil Love, MD
Research To Practice
Miami, Florida

Not an official event of the 2018 Genitourinary Cancers Symposium. Not sponsored, endorsed, or accredited by any of the cosponsoring organizations of the 2018 Genitourinary Cancers Symposium.

Agenda

6:15 PM – 6:45 PM (Pacific Time) — Registration and Dinner Buffet
6:45 PM – 8:45 PM (Pacific Time) — Educational Meeting

Overview
This symposium will focus on the discussion of actual cases of prostate cancer (PC) provided by 5 investigators specializing in the management of advanced PC who will serve as the faculty. Research To Practice (RTP) president and medical oncologist Dr Neil Love will moderate the symposium. Leading up to the conference, Penn State College of Medicine and RTP will recruit 20 additional PC investigators who, along with the faculty, will participate in a unique educational assessment designed to document their collective practice patterns related to an array of common and less frequently encountered clinical scenarios. Key data points from this assessment will be used to formulate the program agenda, which will be divided into 5 modules. Each module will feature a faculty member-led review of emerging and ongoing research and a corresponding panel discussion related to the presentation and relevant data points generated from the premeeting expert assessment. Clinician attendees will use iPads® to complete a similar survey, and the results from both cohorts will be juxtaposed throughout the event to foster additional discussion and debate.

MODULE 1: Existing and Emerging Therapeutic Strategies for the Management of M0 Prostate Cancer (PC) — Dr Petrylak

SAMPLE CONSENSUS-BUILDING/INVESTIGATOR SURVEY QUESTIONS
  • A 65-year-old man is s/p prostatectomy and pelvic radiation therapy with a rising PSA (10 ng/mL) and a PSA doubling time of 7 months. Would you administer androgen deprivation therapy (ADT)? What if the PSA doubling time were 4 months? What if the patient were 80 years old?
  • Do you consider PSA doubling time, absolute PSA level, time since local therapy and/or original Gleason score when determining whether to treat or observe PSA-only relapse? In general, do most patients with PSA-only disease receive systemic therapy or do you try to observe most of them?
  • Do you generally use intermittent or continuous ADT in the treatment of PSA-only disease?
  • Do you believe that clinical trial evidence is adequate to support the use of secondary hormonal therapy for patients with M0 disease? If so, in which specific clinical situations would you recommend this approach? What about the use of sipuleucel-T in this population? Cytotoxic therapy?

Faculty Presentation/Discussion Topics

  • Early clinical trial results evaluating the use of secondary hormonal agents for patients with nonmetastatic castration-resistant PC (CRPC) (eg, STRIVE, IMAAGEN)
  • Clinical implications of Phase III findings from the PROSPER trial comparing enzalutamide to placebo for patients with nonmetastatic CRPC
  • Mechanism of action and early efficacy and safety data with the novel androgen receptor inhibitors apalutamide and darolutamide
  • Design, eligibility criteria and major safety and efficacy results from the Phase III SPARTAN trial of apalutamide versus placebo for nonmetastatic CRPC; potential clinical role of apalutamide

MODULE 2: Management of Hormone-Sensitive Metastatic PC (mHSPC) — Dr Fizazi

SAMPLE CONSENSUS-BUILDING/INVESTIGATOR SURVEY QUESTIONS

  • How frequently do you encounter patients with mHSPC? Do you manage metastatic PC (mPC) differently for patients presenting with de novo disease than for those experiencing recurrence after local therapy?
  • Cost and reimbursement issues aside, what systemic therapy, if any, would you recommend in addition to ADT for a patient with asymptomatic, treatment-naïve PC and 3 rib metastases? What if the patient had widespread bone metastases? What if the disease were symptomatic with documented liver and bone metastases?
  • Do you believe that the results of the Phase III LATITUDE and STAMPEDE trials provide sufficient evidence to support the routine use of abiraterone acetate and prednisone in addition to ADT for patients with treatment-naïve mPC? If so, for which specific patients do you foresee adopting this approach?
  • Are there any clinical scenarios in which you will administer ADT and then add docetaxel if the patient doesn’t respond? What about adding abiraterone in a similar situation?

Faculty Presentation/Discussion Topics

  • Selection of patients with mHSPC for treatment with ADT alone
  • Long-term efficacy and quality-of-life data with docetaxel and ADT for men with hormone-naïve mPC
  • Design, entry criteria and patient accrual to the Phase III LATITUDE and STAMPEDE trials evaluating the addition of abiraterone and prednisone to standard ADT in patients with locally advanced or hormone-sensitive mPC
  • Effects of adding abiraterone to standard ADT on primary (overall survival) and secondary (progression-free survival, incidence/timing of skeletal events, et cetera) outcomes in the LATITUDE and STAMPEDE trials

MODULE 3: Clinical Algorithms for Patients with Metastatic CRPC (mCRPC) — Dr Taplin

SAMPLE CONSENSUS-BUILDING/INVESTIGATOR SURVEY QUESTIONS

  • In general, what is your usual treatment approach for a fit, younger patient with low-volume, asymptomatic bone metastases that develop during ADT for PSA-only disease? What if the patient developed moderate symptoms? What if the lesions were located in the bone and soft tissue (eg, liver)? What if the patient were 80 years old?
  • In general, what second-line treatment would you recommend for a fit patient with asymptomatic bone metastases that develop during ADT with docetaxel for mHSPC? What if the patient were receiving abiraterone and ADT? What if the patient had significant disease to the bone after exposure to ADT/docetaxel or ADT/abiraterone?
  • Given the feasibility of a significant proportion of patients now receiving secondary hormonal therapy or chemotherapy (with ADT) for mHSPC, where do you see sipuleucel-T fitting into future clinical algorithms? Based on available data, are you more inclined to use sipuleucel-T for African American patients than you previously were?
  • Do you use cabazitaxel for patients with recent disease progression on docetaxel, and if so, have you observed clinical benefit and/or responses? How would you compare the side effects and tolerability of docetaxel and cabazitaxel in mCRPC?

Faculty Presentation/Discussion Topics

  • Significance of the earlier use of chemotherapy and secondary hormonal therapy in the selection and sequencing of systemic treatment for mCRPC
  • Importance of age, performance status, symptomatology and prior therapeutic exposure/response in the selection and sequencing of secondary hormonal therapy, immunotherapy and cytotoxic therapy for mCRPC
  • Patient selection for sipuleucel-T in clinical practice; effects of tumor burden, extent of disease and race on its clinical utility
  • Active clinical trials evaluating other novel agents (eg, apalutamide) and strategies (eg, antiandrogen with sipuleucel-T) in mCRPC

MODULE 4: Bone-Targeted Therapies and Other Emerging Radiopharmaceuticals — Dr Sartor

SAMPLE CONSENSUS-BUILDING/INVESTIGATOR SURVEY QUESTIONS

  • Do you generally use bone-targeted therapy (denosumab or zoledronic acid) for patients with mHSPC in the bones who are receiving ADT alone or in combination with docetaxel? What if the patient were receiving ADT and a secondary hormonal intervention? What about for patients with mCRPC and bone metastases?
  • In which clinical situations do you recommend radium-223 chloride? Do you generally use radium-223 alone or combined with other therapies, including endocrine agents, chemotherapy or immunotherapy? What about external beam radiation therapy and bisphosphonates or denosumab? Do you generally recommend radium-223 to patients with disease outside the bone?
  • Have patients in your clinical practice experienced relief of bone pain with radium-223?
  • In your opinion, does radium-223 result in clinically apparent myelosuppression or impair the subsequent use of chemotherapy?

Faculty Presentation/Discussion Topics

  • Patient selection for radium-223 chloride
  • Design, eligibility criteria and rationale for early unblinding of the Phase III ERA223 trial evaluating radium-223 in combination with abiraterone for chemotherapy-naïve mCRPC
  • Correlation between exposure to radium-223 and clinical outcomes
  • Available clinical trial data on the effects of radium-223 on the bone marrow (eg, cytopenia, myelodysplastic syndromes/acute myeloid leukemia)
  • Early activity and safety results and ongoing evaluation of other novel radiopharmaceuticals (eg, 225Ac-PSMA-617, 177Lu-PSMA-617)

MODULE 5: Other Promising Novel Agents and Strategies Under Investigation — Dr Dreicer

SAMPLE CONSENSUS-BUILDING/INVESTIGATOR SURVEY QUESTIONS

  • Do you currently screen your patients with mPC for germline mutations such as BRCA1 or BRCA2? If so, is this something you do selectively (eg, patients with a family history) or do you recommend it for everyone? Do you approach these decisions differently for men with localized PC?
  • Have you prescribed or would you prescribe a PARP inhibitor for a patient with mPC and a BRCA germline mutation?
  • To how many patients with mPC, if any, have you administered an immune checkpoint inhibitor? Have you observed any meaningful responses in these individuals?
  • Do you believe a role exists for next-generation sequencing (NGS) to inform protocol or nonresearch decision-making for patients with advanced PC? Have you ordered NGS for any of your patients, and if so, which targetable mutations, if any, did it identify?
  • What other novel agents or strategies in development appear particularly promising for patients with PC?

Faculty Presentation/Discussion Topics

  • Incidence of somatic or germline BRCA1, BRCA2 or ATM mutations in patients with mCRPC; ongoing evaluation of PARP inhibition as a therapeutic strategy
  • Available research data and current clinical trials with PARP inhibitors in BRCA mutation-positive mCRPC
  • Published efficacy and safety findings with anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies for mCRPC; ongoing clinical trials
  • Spectrum of somatic mutations in patients with mPC and potential role of NGS to inform protocol or nonresearch decision-making

CE Information

Target Audience:
This activity has been designed to meet the educational needs of medical and radiation oncologists, urologists and other allied healthcare professionals involved in the treatment of prostate cancer (PC).

Learning Objectives:
At the conclusion of this activity, participants should be able to:

  • Appraise recent data on diagnostic and therapeutic advances in PC, and integrate this information, as appropriate, into current clinical care.
  • Evaluate emerging clinical trial data with available and investigational immunotherapeutic, chemotherapeutic and secondary hormonal agents in the management of nonmetastatic PC, and consider this information in the discussion of protocol and nonresearch treatment options.
  • Explore available data with cytotoxic and secondary hormonal therapy in the setting of hormone-sensitive metastatic PC, and consider this information when designing treatment plans for appropriate individuals.
  • Effectively apply evidence-based research findings in the determination of best-practice sequencing of available immunotherapeutic, chemotherapeutic and secondary hormonal agents for patients with metastatic castration-resistant PC.
  • Consider available research data and expert perspectives on the efficacy and safety of radium-223 chloride as monotherapy or in combination with other treatment modalities for advanced PC, and use this information to appropriately integrate this radiopharmaceutical agent into clinical practice.
  • Assess emerging data on the prevalence and landscape of mutations in DNA repair genes (eg, BRCA1, BRCA2, ATM) in metastatic PC and their potential therapeutic relevance.

CME Credit Form:
A CME credit form will be given to each participant at the conclusion of the activity.

Accreditation Statement:
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Penn State College of Medicine and Research To Practice. Penn State College of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation Statement:
Penn State College of Medicine designates this live activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure Policy:
It is the policy of Research To Practice and Penn State College of Medicine to ensure balance, independence, objectivity and scientific rigor in all their educational programs. All faculty, planners and managers participating in this activity are required to disclose any relevant financial relationship(s) they (or spouse/partner) have with a commercial interest that benefits the individual in any financial amount that has occurred within the past 12 months; and the opportunity to affect the content of CME about the products or services of the commercial interest. Research To Practice and Penn State College of Medicine will ensure that any conflicts of interest are resolved before the educational activity occurs. Financial disclosures will be provided in meeting course materials.

Supporters:
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, and Sanofi Genzyme.

Location

San Francisco Marriott Marquis
780 Mission Street
San Francisco, CA 94103
Hotel Phone: (415) 896-1600

Meeting Room:
Yerba Buena Ballroom, Salon 9-15 (Lower B2 Level)

Directions:
The San Francisco Marriott Marquis is located just 2 blocks (less than 0.2 miles) from the Moscone Center.

 

Registration

This activity has been designed to meet the educational needs of medical and radiation oncologists, urologists and other allied healthcare professionals involved in the treatment of prostate cancer.

There is no registration fee for this event. However, preregistration is advised as seating is limited.

Registration for clinicians in practice

I am a practicing physician, nurse, fellow or other healthcare provider involved in the treatment of cancer.

Registration for clinicians in practice »
 
Registration for other/industry professionals*

Please note, a limited number of seats are currently available for nonclinicians on a first come, first served basis.

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* Individuals employed by for-profit organizations, including financial institutions, biotech or pharmaceutical companies
Registration for groups
If you are registering a group (more than 1 person) for this event, please contact us at Meetings@ResearchToPractice.com or (800) 233-6153.
To ensure seating, please check in at our onsite registration desk at least 30 minutes prior to the start of the meeting. We cannot guarantee seating after the start of the program.

Meal service will be provided to those who attend the program, based on availability.

Photography and/or video recording may be taken during the educational program by Research To Practice and used in future CME/CNE programs.

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