Learn how Androgen Receptor Pathway Inhibitors (ARPIs) are utilized in treating metastatic castration-sensitive prostate cancer (mCSPC). This video breaks down current clinical guidelines, key evidence, and best practices for incorporating ARPI therapy into patient management.
PA-C
Carly earned her Master’s Degree in Physician Assistant Studies from Thomas Jefferson University in Philadelphia, Pennsylvania, following her Bachelor of Science degree from the University of Delaware in Newark.
Becoming a Physician Assistant has been a lifelong goal for Carly, driven by her enduring passion for collaborative, patient-focused care. As a MidLantic Urology Advanced Prostate Cancer Champion specializing in the management and treatment of the disease, she serves as the Lead APP within MidLantic Urology and is an active member of the Urology Alliance APP Committee.
Dedicated to making a meaningful difference in her patients’ lives, Carly brings a warm, empathetic, and personalized approach to every interaction. Outside of her practice, she enjoys antiquing, crafting, and spending quality time with family and friends.
Coming Soon
Ask The Experts #2 will be available here shortly.
Description about the video
PA-C
Carly earned her Master’s Degree in Physician Assistant Studies from Thomas Jefferson University in Philadelphia, Pennsylvania, following her Bachelor of Science degree from the University of Delaware in Newark.
Becoming a Physician Assistant has been a lifelong goal for Carly, driven by her enduring passion for collaborative, patient-focused care. As a MidLantic Urology Advanced Prostate Cancer Champion specializing in the management and treatment of the disease, she serves as the Lead APP within MidLantic Urology and is an active member of the Urology Alliance APP Committee.
Dedicated to making a meaningful difference in her patients’ lives, Carly brings a warm, empathetic, and personalized approach to every interaction. Outside of her practice, she enjoys antiquing, crafting, and spending quality time with family and friends.
Coming Soon
Ask The Experts #3 will be available here shortly.
Learn how to navigate ARPI dosing, mitigate toxicities, and improve treatment adherence in patients with metastatic castration-sensitive prostate cancer.
MSN, APRN, FNP-C
Erin Pierce graduated with a Bachelor of Science in Nursing from Louisiana State University in 2010 and earned a Master of Science in Nursing from the University of South Alabama in 2015.
She is a nurse practitioner and associate clinical investigator at HonorHealth Research Institute in Scottsdale, Arizona with a focus on genitourinary and pancreatic cancer research.
Erin has served as a sub-investigator for over 100 clinical trials and is proud to be one of the few advanced practitioners to serve as a primary investigator in prospective early phase clinical trials in the country.
Personal experiences with both of her parents being cancer survivors, Erin remains committed to advancing cancer care through research, innovation, and compassionate patient care.
She has helped develop groundbreaking initiatives, including Louisiana’s first early-phase research program, pioneered an award-winning digital home monitoring program for cancer patients, started Louisiana’s first advanced prostate cancer clinic and helped coordinate precision medicine testing for over 3,000 cancer patients. Erin has authored publications, presented at national meetings, and contributed to raising millions for cancer research.
Coming Soon
Ask The Experts #4 will be available here shortly.
Explore real-world patient cases highlighting actionable tips for optimizing ARPI treatment, overcoming common clinical challenges, and ensuring continuous care.
MSN, APRN, FNP-C
Erin Pierce graduated with a Bachelor of Science in Nursing from Louisiana State University in 2010 and earned a Master of Science in Nursing from the University of South Alabama in 2015.
She is a nurse practitioner and associate clinical investigator at HonorHealth Research Institute in Scottsdale, Arizona with a focus on genitourinary and pancreatic cancer research.
Erin has served as a sub-investigator for over 100 clinical trials and is proud to be one of the few advanced practitioners to serve as a primary investigator in prospective early phase clinical trials in the country.
Personal experiences with both of her parents being cancer survivors, Erin remains committed to advancing cancer care through research, innovation, and compassionate patient care.
She has helped develop groundbreaking initiatives, including Louisiana’s first early-phase research program, pioneered an award-winning digital home monitoring program for cancer patients, started Louisiana’s first advanced prostate cancer clinic and helped coordinate precision medicine testing for over 3,000 cancer patients. Erin has authored publications, presented at national meetings, and contributed to raising millions for cancer research.
Cerebrovascular and Ischemic Cardiovascular Events, including events leading to death, occurred in patients receiving ERLEADA. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA for Grade 3 and 4 events.
In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4.4% of patients treated with ERLEADA and 1.5% of patients treated with placebo. Three patients treated with ERLEADA died from an ischemic cardiovascular event, one patient treated with ERLEADA died from sudden cardiac death, and one patient treated with ERLEADA died from cardio-respiratory arrest. Patients with history of unstable angina, myocardial infarction, congestive heart failure, stroke, or transient ischemic attack within 6 months of randomization were excluded from the TITAN study.
In the TITAN study, cerebrovascular events occurred in 1.9% of patients treated with ERLEADA and 2.1% of patients treated with placebo. One patient treated with ERLEADA died from a cerebrovascular accident.
Fractures occurred in patients receiving ERLEADA. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.
In a randomized study (TITAN) of patients with mCSPC, fractures occurred in 9% of patients treated with ERLEADA and in 6% of patients treated with placebo. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.
Falls occurred in patients receiving ERLEADA with increased frequency in the elderly. Evaluate patients for fall risk.
Seizure occurred in patients receiving ERLEADA. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA. Advise patients of the risk of developing a seizure while receiving ERLEADA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.
Severe Cutaneous Adverse Reactions — Fatal and life-threatening cases of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) occurred in patients receiving ERLEADA [see Adverse Reactions (6.2)].
Monitor patients for the development of SCARs. Advise patients of the signs and symptoms of SCARs (eg, a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy). If a SCAR is suspected, interrupt ERLEADA until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other Grade 4 skin reactions, permanently discontinue ERLEADA [see Dosage and Administration (2.2) and Adverse Reactions (6.1)].
Interstitial Lung Disease (ILD)/Pneumonitis — Fatal and life-threatening interstitial lung disease (ILD) or pneumonitis can occur in patients treated with ERLEADA.
Post-marketing cases of ILD/pneumonitis, including fatal cases, occurred in patients treated with ERLEADA. In the TITAN study, 1.1% of patients treated with ERLEADA experienced ILD/pneumonitis [see Adverse Reactions (6.1, 6.2)].
Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold ERLEADA if ILD/pneumonitis is suspected. Permanently discontinue ERLEADA in patients with severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified [see Dosage and Administration (2.2)].
Embryo-Fetal Toxicity — The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1, 8.3)].
Interference with Immunoassay Measurement of Digoxin — ERLEADA can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving ERLEADA and digoxin [see Drug Interactions (7.3)].
In the TITAN study, the most common adverse reactions (≥10%) that occurred more frequently in the ERLEADA-treated patients (≥2% over placebo) were arthralgia, rash, pruritus, hot flush, and hypertension.
Laboratory Abnormalities — All Grades (Grade 3-4)
Hematology — In the TITAN study: white blood cell decreased ERLEADA 27% (0.4%), placebo 19% (0.6%).
Chemistry — In the TITAN study: hypertriglyceridemia ERLEADA 17% (2.5%), placebo 12% (2.3%).
Rash — Rash was most commonly described as macular or maculopapular. In the TITAN study, adverse reactions of rash were 28% with ERLEADA vs 9% with placebo. Grade 3 rashes (defined as covering >30% body surface area [BSA]) were reported with ERLEADA treatment (6%) vs placebo (0.6%).
Hypothyroidism — In the TITAN study, hypothyroidism was reported for 3.6% of patients treated with ERLEADA and 0.6% of patients treated with placebo.
Effect of Other Drugs on ERLEADA
Strong CYP2C8 or CYP3A4 Inhibitors
Reduce the ERLEADA dose as recommended for adverse reactions [see Dosage and Administration (2.2)]. Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl-apalutamide).
Effect of ERLEADA on Other Drugs
Substrates of CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP, or OATP1B1
Refer to the Prescribing Information for these substrates. Consider alternative agents when possible or evaluate for loss of activity of the substrate if concomitant use cannot be avoided.
Apalutamide is a strong inducer of CYP3A4 and CYP2C19, a weak inducer of CYP2C9, and an inducer of P-gp, BCRP, and OATP1B1. Apalutamide decreases exposure of substrates of CYP3A4, CYP2C19, CYP2C9, P-gp, BCRP, or OATP1B1, which may decrease the effectiveness of these substrates.
USE IN SPECIFIC POPULATIONS
The recommended ERLEADA dosage in patients with severe hepatic impairment (Child-Pugh C) is lower than the recommended dosage in patients with normal hepatic function. No dosage modification is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Please see full Prescribing Information for ERLEADA.
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ERLEADA® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with: