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Enzalutamide With Radiation Therapy for Intermediate-Risk Prostate Cancer: A Phase 2 Study.

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Enzalutamide monotherapy with radiation therapy shows effectiveness for intermediate-risk prostate cancer, with 77% achieving a PSA nadir of ≤0.2 ng/mL. This approach may offer a better-tolerated alternative to androgen deprivation therapy (ADT).

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Area of Science:

  • Oncology
  • Urology
  • Clinical Trials

Background:

  • Androgen deprivation therapy (ADT) is a common adjuvant treatment for intermediate-risk prostate cancer, often combined with radiation therapy (RT).
  • ADT is associated with significant side effects, including weight gain, decreased libido, and hot flashes.
  • Antiandrogen monotherapy is generally better tolerated than ADT, prompting investigation into its efficacy.

Purpose of the Study:

  • To assess the effectiveness of enzalutamide monotherapy combined with radiation therapy (RT) for intermediate-risk prostate cancer.
  • To compare the efficacy and side effect profile of enzalutamide monotherapy with traditional ADT.

Main Methods:

  • An open-label, phase 2 study involving 64 patients with intermediate-risk prostate cancer.
  • Patients received 6 months of enzalutamide monotherapy, initiated 2 months prior to external beam RT.
  • Primary endpoint: Prostate-specific antigen (PSA) response (nadir ≤0.2 ng/mL) at 6 months; secondary endpoints: toxicity, body measurements, sexual function, and metabolism.

Main Results:

  • Efficacy endpoint met: 77% (49/64) of patients achieved a PSA nadir ≤0.2 ng/mL, and 94% (60/64) had PSA ≤0.5 ng/mL.
  • Most frequent adverse events included hypertension and gynecomastia.
  • No significant changes in body measurements were observed, and erectile dysfunction was modest.

Conclusions:

  • Enzalutamide monotherapy with RT demonstrates comparable efficacy to ADT plus RT for intermediate-risk prostate cancer, based on PSA response.
  • This regimen appears to be better tolerated than ADT, with fewer significant side effects.
  • Randomized trials comparing enzalutamide directly with ADT are warranted to confirm these findings.