Is a sore throat a side effect of Apalutamide (generic name) for prostate cancer?

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Sore Throat as a Side Effect of Apalutamide for Prostate Cancer

Sore throat is not listed as a common side effect of apalutamide for prostate cancer treatment. Based on the comprehensive clinical trial data and guidelines, sore throat is not mentioned among the documented adverse events associated with apalutamide therapy.

Common Side Effects of Apalutamide

According to the SPARTAN trial data, which was the pivotal phase III study leading to FDA approval of apalutamide for non-metastatic castration-resistant prostate cancer (nmCRPC), the most frequently reported adverse events include:

  • Rash (23.8% vs 5.5% in placebo) 1
  • Fatigue (30.4% vs 21.1%) 1
  • Hypertension (24.8% vs 19.8%) 1
  • Diarrhea (20.3% vs 15.1%) 1
  • Nausea (18.1% vs 15.8%) 1
  • Weight loss (16.1% vs 6.3%) 1
  • Arthralgia (15.9% vs 7.5%) 1
  • Falls (15.6% vs 9.0%) 1
  • Fracture (11.7% vs 6.5%) 1
  • Hypothyroidism (8.1% vs 2.0%) 1

Dermatological Concerns with Apalutamide

Skin rash is one of the most significant and characteristic side effects of apalutamide:

  • In the SPARTAN trial, rash occurred in 23.8% of patients receiving apalutamide compared to 5.5% in the placebo group 1
  • The TITAN trial also reported rash as more common with apalutamide than placebo (27.1% versus 8.5%) 1
  • Early identification and management of rash is important to prevent treatment interruptions 2

Monitoring and Management Recommendations

While sore throat is not specifically mentioned as a side effect, patients on apalutamide should be monitored for:

  • Thyroid function changes, as hypothyroidism occurred in 8.1% of patients (vs 2.0% in placebo) 1
  • Skin reactions, particularly rash which may require early intervention 2
  • Fracture risk (11.7% vs 6.5%) 1

Clinical Implications

When prescribing apalutamide for prostate cancer patients:

  1. Focus patient education on the common side effects (rash, fatigue, hypertension)
  2. Implement proactive skin care from the start of treatment
  3. Monitor thyroid stimulating hormone regularly, especially in patients with known hypothyroidism
  4. Be vigilant for less common but serious adverse events like seizures (0.2% in the SPARTAN trial) 1

If a patient on apalutamide reports a sore throat, consider other causes, as this is not a documented side effect of the medication based on the extensive clinical trial data from SPARTAN and TITAN studies.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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