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"When we select abiraterone for our patients with mHSPC, there's a choice between generic and branded options," says Paul C. Dato MD.
Paul C. Dato, MD
In a recent Case-Based Peer Perspectives video series for Urology Times, Paul E. Dato, MD, discussed several patient cases of metastatic hormone-sensitive prostate cancer (mHSPC) and outlined the 3 available versions of the treatment abiraterone acetate. What follows is an excerpt from this program.
Dato is a urologist and medical director of the Cancer Center of Excellence at Unio Specialty Care in San Diego, California.
Patient profile: A 69-year-old Black man presents with fatigue, nocturnal diuresis, persistent low back pain, unintentional weight loss, and urinary difficulties.
Clinical assessment: Prostate-specific antigen (PSA) significantly elevated at 78 ng/mL, normal testosterone, mildly elevated alkaline phosphatase, multiparametric MRI revealing a Prostate Imaging Reporting and Data System 5 lesion with suspected extracapsular extension
Diagnostic findings: A prostate-specific membrane antigen PET/CT scan shows multiple osseous metastases in the lumbar spine and pelvis, pelvic lymphadenopathy, and positive germline testing for BRCA mutation.
Initial treatment approach: Androgen deprivation therapy (ADT) with luteinizing hormone–releasing hormone agonist or antagonist, followed by the addition of abiraterone acetate with prednisone
• Initial ADT reduced PSA level from 78 ng/mL to 17 ng/mL and improved pain score from 6/10 to 3/10. Treatment with abiraterone acetate (1000 mg daily with 5 mg prednisone twice a day) further suppressed the PSA level to 9 ng/mL.
This transcript was generated by artificial intelligence and edited by humans for length and clarity.
Dato: This patient's clinical presentation and disease characteristics, unfortunately, are an all-too-common occurrence, with some minor variations. This is quite typical of patients presenting today as a result of…the reduction of screening for prostate cancer. It is precisely the clinical presentation, biological and molecular markers, and other parameters, such as disease volume, timing, and location of metastatic disease, and other individual patient characteristics, that direct the treatment approach.
Dato compared the versions of abiraterone acetate.
When we select abiraterone for our patients with mHSPC, there's a choice between generic and branded options, and there are several factors to consider. There are 3 formulations of abiraterone available to patients. These are standard abiraterone [Zytiga], generic abiraterone, and the micronized formulation [Yonsa]. Choosing between these agents involves considering several factors, including cost, familiarity, availability, tolerability, and patient access, which is driven chiefly by insurance coverage determinations. All these drugs have equal bioavailability, so they should achieve the same therapeutic effect if taken as prescribed. The micronized version is designed to enhance its bioavailability, thus allowing for a lower total dose while achieving similar plasma levels compared with branded or generic abiraterone. But there is a potential for clinical trade-offs. Both standard and generic abiraterone need to be taken in a fasting state; that is, the patient needs to [have nothing by mouth] for 2 hours prior to and 1 hour after ingestion. That's a total of 3 hours. This may be difficult for some patients, especially those who develop hypoglycemia, such as [patients with] diabetes. There's a risk that they could eat during the fasting period to alleviate hypoglycemia, which could lead to elevated drug plasma levels and thus lead to toxicity. Also, those individuals with upper [gastrointestinal] disorders such as gastroesophageal reflux disease may also have difficulty with fasting requirements and develop gastric irritation. The micronized version allows for consumption of food, obviating the need for fasting, simplifying the regimen, and potentially improving adherence. This is one of the key differences between the formulations. Additionally, the small particle size of the micronized version allows for faster dissolution and absorption. For the other formulations, a total lower dosage could also reduce some of the other [adverse events] common in androgen signaling pathway inhibitors, such as fatigue.