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TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic

Neeraj Agarwal1, Fred Saad2, Arun A Azad3

  • 1Huntsman Cancer Institute, University of Utah, Salt Lake City, UT 84112, USA.

Future Oncology (London, England)
|October 26, 2023
PubMed

Insights

Poly(ADP-ribose) polymerase inhibitors combined with androgen-receptor signaling inhibitors show promise for metastatic castration-sensitive prostate cancer. The TALAPRO-3 study investigates if talazoparib plus enzalutamide improves outcomes compared to enzalutamide alone in patients with HRR gene alterations.

Area of Science:

  • Oncology
  • Genetics
  • Clinical Trials

Background:

  • Metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) gene alterations presents a therapeutic challenge.
  • Poly(ADP-ribose) polymerase (PARP) inhibitors and androgen-receptor signaling inhibitors (ARSIs) are emerging as effective treatments.
  • Combination therapies are being explored to enhance efficacy in mCSPC.

Purpose of the Study:

  • To evaluate the efficacy and safety of talazoparib plus enzalutamide versus placebo plus enzalutamide in patients with mCSPC and HRR gene alterations.
  • To determine if the addition of talazoparib improves radiographic progression-free survival (rPFS) in this patient population.
  • To assess the impact of combination therapy on outcomes in patients undergoing androgen deprivation therapy.

Main Methods:

  • Multinational, phase III clinical trial (TALAPRO-3).
  • Comparison of talazoparib plus enzalutamide versus placebo plus enzalutamide.
  • Primary endpoint: investigator-assessed radiographic progression-free survival (rPFS) using RECIST 1.1 and PCWG3 criteria.

Main Results:

  • N/A - Study ongoing, results not yet available.

Conclusions:

  • N/A - Study ongoing, conclusions cannot be drawn at this time.
Keywords:
HRRPARP inhibitorandrogen receptorenzalutamidemCSPCtalazoparib

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