Improving Management of Non-Metastatic Castrate Resistant
Prostate Cancer (nmCRPC)
December 6, 2018 :: 1:00 – 2:00 PM EST
Megan McNamara, MD
Mary W. Dunn, RN, MSN, OCN, NP-C
Duke Cancer Institute
University of North Carolina Chapel Hill
Jointly provided by Postgraduate Institute for Medicine and Carevive Systems, Inc.
This activity is supported by an independent educational grant from Astellas
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
Target Audience
The target audiences for these activities are urologists, medical oncologists, urology/oncology nurses, advanced practice registered nurses and
nurse navigators.
Educational Objectives
At the conclusion of this educational initiative, participants should be able to:
• Utilize new data regarding the evidence-based management of patients with nmCRPC
• Discuss implications of decisions regarding timing and treatment sequencing for patients with nmCRPC on subsequent therapy
• Identify ongoing late phase clinical trials in nmCRPC
• Implement strategies to manage education and symptoms for men with nmCRPC
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Carevive
Systems, Inc. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the
Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for
the healthcare team.
Physician Continuing Medical Education
The Postgraduate Institute for Medicine designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim
only the credit commensurate with the extent of their participation in the activity.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 1.0 contact hours. Designated for 0.7 contact hours of
pharmacotherapy credit for Advanced Practice Registered Nurses.
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
2
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content
of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are
thoroughly vetted and resolved according to PIM policy. The existence or absence of COI for everyone in a position to control content will be
disclosed to participants prior to the start of each activity.
Faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial
interests related to the content of this CME activity:
Faculty Disclosures
Megan McNamara, MD Contracted Research: Funds directed towards institution from Bayer, Janssen, Clovis, Agensys, and Seattle Genetics;
Speaker’s Bureau: Bayer
Mary W. Dunn, NP has no real or apparent conflicts of interest to report.
Planners and Managers
The PIM planners and managers have nothing to disclose. The Carevive planners and managers have nothing to disclose.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners
of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are
those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product
for discussion of approved indications, contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional
development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications,
or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their
patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and
comparison with recommendations of other authorities.
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
3
Agenda
1:00 – 1:25 pm
Evolving Evidence-Based Treatment Paradigms for nmCRPC
Megan McNamara, MD
1:25 – 1:50 pm
Supportive Care for the Treatment of Men with CRPC
Mary W. Dunn, RN, MSN, OCN, NP-C
1:50 – 2:00 pm
Discussion Q & A
Expert Panel & Audience
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
4
Improving Management of Non-Metastatic
Castration-Resistant Prostate Cancer
(nmCRPC)
Megan McNamara, MD
Duke Cancer Institute
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
Non-metastatic castrate resistant prostate cancer (nmCRPC or m0 CRPC)
Figure: Eric Small, GU ASCO 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
6
Metastasis-free survival in nm CRPC
Risk of bone metastases or death increases
as PSADT decreases below 8 months
Median time to bone metastasis or death is
shorter in patients with PSADT ≤10 months
Smith, MR. JCO 2013
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
7
SPARTAN
PROSPER
Smith MR, et al. NEJM 2018
Hussain M, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
8
SPARTAN (apalutamide) Study Design: Phase 3 Placebo-Controlled
Randomized Trial
Figure: Eric Small, GU ASCO 2018
Small EJ, et al. J Clin Oncol 36, 2018 (suppl 6S; abstr 161)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
9
SPARTAN (apalutamide): Endpoints
Figure: Eric Small, GU ASCO 2018
Small EJ, et al. J Clin Oncol 36, 2018 (suppl 6S; abstr 161)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
10
SPARTAN (apalutamide): Baseline Characteristics
Smith MR, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
11
SPARTAN (apalutamide): Primary Endpoint Metastasis-Free Survival
40.5 mo vs. 16.2 mo
Median duration of follow-up 20.3 months
Smith MR, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
12
SPARTAN (apalutamide): Secondary and Exploratory Endpoints
Smith MR, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
13
SPARTAN (apalutamide): Subsequent Treatment
Apalutamide
Placebo
Received study treatment
803
398
Discontinued study treatment
314
279
165 (53%)
217 (78%)
125 (40%)
161 (58%)
Enzalutamide
20 (6%)
28 (10%)
Docetaxel
15 (5%)
18 (6%)
Cabazitaxel
0
1 (<1%)
Sipuleucel-T
4 (1%)
9 (3%)
Radium
1 (<1%)
0
Received approved therapy for
mCRPC
• 78% of placebo arm patients who d/c’d
study treatment subsequently received
an approved therapy for mCRPC vs.
53% of apalutamide arm patients
First subsequent approved therapy
Abiraterone
• 68% of placebo arm patients who d/c’d
study treatment were subsequently
treated with abi or enza vs. 46% of
apalutamide arm patients
Small EJ, et al. J Clin Oncol 36, 2018 (suppl 6S; abstr 161)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
14
SPARTAN (apalutamide):
Adverse Events
The following adverse
events that were considered
by the investigators to be
related to the trial regimen
occurred at a higher rate in
the apalutamide group than
in the placebo group:
•
•
•
•
•
•
Fatigue
Rash
Falls
Fracture
Hypothyroidism
Seizure
Smith MR, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
15
Apalutamide Rash Management
• Macular or maculo-popular
• Grade 1-2 in 24%
• Grade 3 (defined as >30% BSA) in 5%
• No reported events of toxic epidermal necrolysis or Stevens-Johnson syndrome
• Onset of skin rash occurred at a median of 82 days of treatment
• Rash resolved in 81% of patients within a median of 60 days (range 2 to 709 days)
• Treatment included topical corticosteroids, oral antihistamines, drug interruption, dose
reduction, and systemic corticosteroids (4% of patients)
• Rash recurred in approximately half of patients who were re-challenged with apalutamide
Smith MR, et al. NEJM 2018
Apalutamide prescribing information
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
16
SPARTAN (apalutamide): PRO Endpoints
HRQol was maintained with the addition of apaulatmide to ADT
Figure: Eric Small, GU ASCO 2018
Small EJ, et al. J Clin Oncol 36, 2018 (suppl 6S; abstr 161)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
17
Apalutamide in nmCRPC FDA approval
February 2018
• Indication: treatment of patients with non-metastatic castration-resistant prostate cancer
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
18
SPARTAN
PROSPER
Smith MR, et al. NEJM 2018
Hussain M, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
19
PROSPER (enzalutamide): Study Design
Figure: Maha Hussain, GU ASCO 2018
Hussain M, et al. J Clin Oncol 36, 2018 (suppl 6S; abstr 3)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
20
PROSPER (enzalutamide):
Baseline Characteristics
Hussain M, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
21
PROSPER (enzalutamide) Primary Endpoint: Metastasis-Free Survival
Median duration of follow-up 18.5 mo in
enzlutamide group and 15.1 mo in placebo
group
Hussain M, et al. NEJM 2018
Figure: Maha Hussain, GU ASCO 2018
Hussain M, et al. J Clin Oncol 36, 2018 (suppl 6S; abstr 3)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
22
PROSPER (enzalutamide): Secondary Endpoints
Hussain M, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
23
PROSPER (enzalutamide): Overall Survival (OS)
Figure: Maha Hussain, GU ASCO 2018
Hussain M, et al. J Clin Oncol 36, 2018 (suppl 6S; abstr 3)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
24
PROSPER (enzalutamide): Subsequent Treatment
Hussain M, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
25
PROSPER (enzalutamide):
Adverse Events
•
•
Enzalutamide side effects were similar to
what has been described previously
Higher rates of the following side effects
were observed in the enzalutamide group,
compared to placebo:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Fatigue
Hot flush
Nausea
Hypertension
Fall
Constipation
Dizziness
Arthralgias
Asthenia
Decreased appetite and weight loss
Headache
Cardiovascular events
Mental impairment disorders
Convulsion
Hussain M, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
26
PROSPER (enzalutamide): Adverse Events of Special Interest
• Incidence of cardiovascular
adverse events was high in
patients with baseline history
of cardiovascular disease,
HTN, diabetes,
hyperlipidemia, or age ≥75
years
• Includes acute MI, hemorrhagic cerebrovascular conditions, ischemic cerebrovascular conditions,
and heart failure
• Memory impairment, disturbance in attention, cognitive disorders, amnesia, dementia Alzheimer’s
type, senile dementia, mental impairment, and vascular dementia
Figure: Maha Hussain, GU ASCO 2018
Hussain M, et al. J Clin Oncol 36, 2018 (suppl 6S; abstr 3)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
27
PROSPER (enzalutamide): HR QOL
There was no difference in QoL between the enzalutamide and placebo group
Hussain M, et al. NEJM 2018
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
28
Enzalutamide in nmCRPC FDA Approval
July 2018
• FDA approved enzalutamide for the patients with castration-resistant prostate cancer
• This broadened the enzalutamide indication to include both patients with non-metastatic
CRPC and metastatic CRPC
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
29
Implications for Timing and Sequencing of Subsequent Therapy
• The optimal sequence of advanced prostate cancer treatments has not been defined in a randomized trial.
• Currently, most patients receive abiraterone or enzalutamide as 1 st line treatment for mCRPC
Enzalutamide
(PREVAIL)
Abiraterone
(COU-302)
PSA decline of ≥50% from
baseline
78%
62%
Median PSA PFS
11.2 months
11.1 months
Median radiographic PFS
20.0 months
16.5 months
• The efficacy of abiraterone or enzalutamide for mCRPC after prior enzalutamide or apalutamide for nmCRPC is not
known
• However, the efficacy of abiraterone after enzalutamide for mCRPC or enzalutamide after abiraterone for mCRPC is
reduced
• PSA response rates ~10-30%, median PSA PFS 3-4 months
• Therefore, although treatment of nmCRPC with enzalutamide or apaluatmide delays development of mCRPC, it may
make androgen-directed treatments for mCRPC less effective.
• The ongoing international prospective IRONMAN registry will provide insight into timing and sequence of therapy for
advanced prostate cancer.
Beer TM, et al. NEJM 2014; Beer TM, et al. Eur Urol 2017; Ryan CJ et al. NEJM 2013; Azad AA, et al. Eur Eurol 2015
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
30
Ongoing Late Phase Clinical Trials
ARAMIS (darolutamide)
• Randomized, Phase III, multi-center, double-blind, placebo-controlled trial of darolutamide
600mg BID in nmCRPC
• Press release October 24, 2018: met primary endpoint – significantly improved MFS,
compared to placebo
• Results expected at GU ASCO 2019
• Has been granted Fast Track designation by the FDA
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
31
Summary
• The addition of enzalutamide or apalutamide to ADT in patients with nmCRPC and PSA
doubling time ≤ 10 mo (and PSA ≥ 2 in PROSPER/enzalutamide) improves metastasisfree survival, compared to ADT alone
• The addition of enzalutamide or apalutamide to ADT in nmCRPC is associated with more
adverse effects, compared to ADT alone
• HR QOL is preserved
• Enzalutamide and apalutamide are FDA approved for patients with nmCRPC
• There may be implications on timing and sequencing of subsequent therapy
• Per a press release, darolutamide also improved metastasis-free survival in nmCRPC,
compared to placebo. Results expected at GU ASCO 2019
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
32
Is metastasis-free survival a surrogate endpoint for overall survival?
• Localized prostate cancer: mFS is a strong surrogate for OS (ICECaP Working Group)
• mCRPC: time to radiographic disease progression correlates with OS (COU-302)
• nmCRPC: unknown
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
33
Thank you
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
34
Improving Management of Non-Metastatic
Castration-Resistant Prostate Cancer
(nmCRPC)
Mary W. Dunn, RN, MSN, OCN, NP-C
University of North Carolina Chapel Hill
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
Supportive Care for the Treatment of Men with CRPC
• Overview
• Apalutamide in the management of nmCRPC (SPARTAN)
• Management of common side effects of apalutamide
• Enzalutamide in the management of nmCRPC (PROSPER)
• Management of common side effects of enzalutamide
• Management of common side effects of androgen deprivation therapy
(ADT)
• Special considerations
• Resources
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
36
Supportive Care for the Treatment of Men with CRPC
Apalutamide
• Androgen receptor inhibitor
• 240 mg PO daily; 60 mg tablets
• With or without food
• Given concurrently with primary androgen deprivation
• Medical castration
• LHRH Agonist (e.g. leuprolide)
• LHRH Antagonist (e.g. degarelix)
• Surgical castration (i.e. bilateral orchiectomy)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
37
Supportive Care for the Treatment of Men with CRPC
Side effects/adverse reactions
• Rash
• Fracture
• Falls
• Hypothyroidism
• Fatigue
• Hypertension
• Peripheral edema
• Diarrhea, nausea
• Lab abnormalities
• Anemia, leukopenia, hypercholesterolemia, hyperglycemia, hypertriglyceridemia,
hyperkalemia
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
38
Supportive Care for the Treatment of Men with CRPC
Rash
• SPARTAN trial
• Incidence: 24% (apalutamide) vs. 6% (placebo)
• Most commonly reported as macular or maculo-papular
• Grade 3 (covering > 30% body surface area); 5% (apalutamide) vs. 0.3% (placebo)
• Onset: median 82 days
• Treatment
• Depends on severity
• Loose, non-irritating clothing; mild soaps; sunscreen
• Topical corticosteroids
• Antihistamines
• Dose reduction
• Drug interruption
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
39
Supportive Care for the Treatment of Men with CRPC
Fracture
• SPARTAN trial
• Incidence: 12% (apalutamide) vs. 7% (placebo)
• Onset: Median 314 days
• Treatment
• Depends on severity, location
• Referral to orthopedics
• Other considerations
• Evaluate patients for risk of fractures
• Immobility, elderly, co morbidities
• Calcium and vitamin D supplementation
• Bone density testing and treatment of osteoporosis were not performed in SPARTAN
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
40
Supportive Care for the Treatment of Men with CRPC
Falls
• SPARTAN trial
• Incidence: 16% (apalutamide) vs. 9% (placebo)
• Other considerations
• Evaluate patients for risk for falls
• Include fall history
• Calcium and vitamin D supplementation
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
41
Supportive Care for the Treatment of Men with CRPC
Risk factors for falls
• Intrinsic
• Hypotension
• hypoglycemia
• Impaired mobility
• Unstable gait
• Poor balance
• MSK deformities
• Neuro disorders
• Limited physical activity endurance
• Peripheral neuropathy
• Impaired vision
• Altered mental status
• Medication side effects
• Incontinence
• History of falls
• Extrinsic
• Conditions in the physical environment
• Poor lighting
• Clutter
• Throw rugs
• Slippery floor
• Uneven surfaces
• Stairs
• Rain/snow/ice
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
42
Supportive Care for the Treatment of Men with CRPC
Hypothyroidism
• SPARTAN trial
• Incidence: 8% (apalutamide) vs. 2% (placebo)
• Based on assessments of thyroid-stimulating hormone (TSH) every 4 months
• Elevated TSH incidence: 25% (apalutamide) vs. 7% (placebo)
• Onset: median 113 days
• Thyroid replacement therapy was initiated in 7% of patients
• Treatment
• Thyroid replacement therapy depends on TSH, free T4, symptoms
• Other considerations
• Check TSH; if abnormal, add additional thyroid function tests to evaluate for
hypothyroidism
• Refer to endocrinology if significant hypothyroidism (no Grade 3 or 4 in trial)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
43
Supportive Care for the Treatment of Men with CRPC
Enzalutamide
• Androgen receptor inhibitor
• Inhibits androgen binding to AR and inhibits AR nuclear translocation and interaction
with DNA
• 160 mg PO daily; 40 mg tablets
• With or without food
• Given concurrently with primary androgen deprivation
• Medical castration
• LHRH Agonist (e.g. leuprolide)
• LHRH Antagonist (e.g. degarelix)
• Surgical castration (i.e. bilateral orchiectomy)
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
44
Supportive Care for the Treatment of Men with CRPC
Side effects/adverse reactions
• Fatigue
• Fracture
• Falls
• Constipation
• Hot flush
• Headache
• Hypertension
• Nausea
• Weight loss
• Lab abnormalities
• Neutropenia, hyperglycemia, hypermagnesemia, hyponatremia
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
45
Supportive Care for the Treatment of Men with CRPC
Constipation
• PROSPER trial
• Incidence: 9% (enzalutamide) vs. 6% (placebo)
• Treatment
• Water
• Fiber
• Polyethylene glycol
• Senna and docusate
• Probiotics
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
46
Supportive Care for the Treatment of Men with CRPC
Side effects/adverse reactions of androgen deprivation therapy
• Hot flashes
• Fatigue
• Sexual dysfunction
• Osteoporosis
• Gynecomastia
• Cardiovascular disease
• Insulin resistance
• Hyperlipidemia
• Cognitive deficits
Result of castrate levels of testosterone
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
47
Supportive Care for the Treatment of Men with CRPC
Hot flashes
• A sensation of warmth that may be accompanied by facial flushing, perspiration, chills,
heart palpitations, night sweats, and feelings of anxiety
• Up to 80% of men experience hot flashes
• Treatment
• Pharmaceuticals
• Venlafaxine 37.5 mg
• Gabapentin (dose varies)
• Lifestyle modification
• Loose cotton clothes, fans, ice, cool room temperature, limit triggers (e.g.
caffeine, spice, alcohol)
• Most men don’t require treatment
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
48
Supportive Care for the Treatment of Men with CRPC
Fatigue
• One of the most common problems in patients with cancer
• 80-100% of people with cancer experience fatigue
• Treatment
• Exercise
• Cognitive behavioral interventions/approach for sleep
• Energy conservation and activity management
• Mindfulness-based stress reduction
• Management of concurrent symptoms
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
49
Supportive Care for the Treatment of Men with CRPC
Sexual dysfunction
• Erectile dysfunction
•
•
•
•
•
Vacuum erection device (VED)
PDE5 Inhibitors
Medicated Urethral System for Erection (MUSE)
Intracavernosal injections (ICI)
Penile implant
• Decreased libido
• 30-90% of men on ADT
• No effective treatment in the setting of advanced prostate cancer
• Penile shrinkage
• On ADT, due to hypogonadal state
• Post-radical prostatectomy, due to unchallenged muscle tone
• VED
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
50
Supportive Care for the Treatment of Men with CRPC
Osteoporosis
• T score -2.5 or lower on DEXA scan
• Treatment
• Zoledronic acid
• IV bisphosphonate
• 4 mg IV
• SE: Hypocalcemia, renal dysfunction, ONJ, flu-like symptoms
• Denosumab
• Monoclonal antibody that targets RANKL, a protein involved in cancer-related
bone destruction
• 60 mg SC every 6 months
• Calcium (minimum 500 mg) and Vitamin D (400 IU)
• Weight bearing exercise
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
51
Supportive Care for the Treatment of Men with CRPC
Key Points
• Patient & caregiver education about potential side effects is crucial
• In general, if > Grade 3 toxicity, hold until symptoms improve to < Grade 1, then resume at
same or reduced dose
• Incorporate compliance assessment into each visit
• Secondary treatment can exacerbate side effects patients already have with their primary
ADT
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
52
Supportive Care for the Treatment of Men with CRPC
Resources
• American Cancer Society
• American Prostate Society
• American Society of Clinical Oncology
• His Prostate Cancer
• Man-to-Man
• National Cancer Institute
• National Comprehensive Cancer Network
• Prostate Cancer Foundation
• US Too
• ZERO- The End of Prostate Cancer
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
53
Thank you
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
54
Discussion Q&A
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
55
Request for Credit
Download your activity evaluation form from the Go To Webinar portal.
A statement of credit will be issued only upon receipt of a completed activity evaluation form
and will be emailed to you within three weeks.
Evaluations can be emailed to inquiries@pimed.com or FAX to 303-790-4876.
You will receive your certificate from CEcertificate@pimed.com.
If you have questions regarding the receipt of your emailed certificate, please contact PIM via
email at inquiries@pimed.com.
©2018 Carevive Systems. All rights reserved. Confidential & Proprietary Information. Do not distribute.
56