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The value of real world evidence and pragmatic trials in advanced prostate cancer- insights from the electronic

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Older prostate cancer patients often have comorbidities and stop chemotherapy due to toxicity. Registry-based trials show similar outcomes but highlight challenges in recruiting for advanced prostate cancer studies.

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Area of Science:

  • Oncology
  • Geriatric Medicine
  • Clinical Trials

Background:

  • Prostate cancer incidence rises with age, yet older adults are underrepresented in clinical trials.
  • The electronic Prostate Cancer Australian and Asian Database (ePAD) captures real-world data from diverse patient populations.
  • Analysis of ePAD data reveals characteristics and outcomes of older metastatic castration-resistant prostate cancer (mCRPC) patients.

Purpose of the Study:

  • To analyze the characteristics and treatment outcomes of older patients with mCRPC using real-world data.
  • To investigate the feasibility and challenges of registry-based randomized controlled trials (RRCTs) in advanced prostate cancer.

Main Methods:

  • Analysis of 753 mCRPC patients from the ePAD registry, focusing on age-related comorbidities and treatment outcomes.
  • Chart review in three centers to assess contraindications and drug interactions for abiraterone and enzalutamide.
  • Conducted the REAL-Pro study, a registry-based randomized controlled trial comparing abiraterone and enzalutamide in advanced prostate cancer.

Main Results:

  • 43% of mCRPC patients in ePAD were 75+, often with comorbidities like heart disease and diabetes.
  • Older patients receiving chemotherapy were more likely to discontinue due to toxicity.
  • Significant contraindications (72% for abiraterone, 14% for enzalutamide) and drug interactions (47% abiraterone, 67% enzalutamide) were observed.
  • The REAL-Pro study closed early due to slow recruitment and a shifting treatment landscape.

Conclusions:

  • Older patients with mCRPC have distinct comorbidity profiles and may experience higher chemotherapy toxicity.
  • Real-world data highlights potential challenges with targeted therapies like abiraterone and enzalutamide in older populations.
  • Further research is needed to optimize pragmatic trial designs, such as RRCTs, and improve recruitment strategies for advanced prostate cancer.