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Related Concept Videos

Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...

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Pre-clinical Orthotopic Murine Model of Human Prostate Cancer
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Multicenter Real-World Study: 432 Patients with Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer.

Juan A Encarnación Navarro1,2,3, Virginia Morillo Macías4, María Borrás Calbo5

  • 1Department Radiation Oncology, Hospital Clínico Universitario Virgen de la Arrixaca, 30120 Murcia, Spain.

Current Oncology (Toronto, Ont.)
|March 26, 2025
PubMed
Summary

Apalutamide combined with androgen deprivation therapy (ADT) significantly improves outcomes for metastatic hormone-sensitive prostate cancer (mHSPC). Rapid, profound prostate-specific antigen (PSA) declines predict better progression-free survival and oncological results.

Keywords:
PSA declineapalutamideprostate cancerultralow PSA

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Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Metastatic hormone-sensitive prostate cancer (mHSPC) management has advanced with androgen receptor-targeted agents (ARTAs).
  • ARTAs combined with androgen deprivation therapy (ADT) improve oncological outcomes and survival in mHSPC patients.

Purpose of the Study:

  • To evaluate prostate-specific antigen (PSA) decline, oncological outcomes, and toxicity of apalutamide in mHSPC.
  • To assess the association between PSA decline and progression-free survival (PFS) in mHSPC patients.

Main Methods:

  • Retrospective analysis of clinical data from 432 mHSPC patients across seven hospitals (March 2021-July 2024).
  • Collection of PSA levels, adverse events, dose modifications, and discontinuations.
  • Evaluation of PSA decline correlation with PFS, metastasis characteristics, and diagnosis timing.

Main Results:

  • 88.2% of patients achieved >90% PSA reduction within one year; 81.7% reached undetectable PSA (≤0.2 ng/mL).
  • 43% of patients achieved ultralow PSA (UL2, <0.02 ng/mL) at 6 months.
  • Drug discontinuation occurred in 15.6% of patients, with grade 3/4 adverse events in 7.8%/1.9%.

Conclusions:

  • Apalutamide demonstrates robust oncological efficacy in mHSPC, characterized by rapid and deep PSA reductions.
  • Achieving ultralow PSA (UL PSA) is a significant predictor of superior oncological outcomes.
  • The safety profile of apalutamide is consistent with existing data, supporting its role in mHSPC management.