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Area of Science:

  • Oncology
  • Genitourinary Cancer
  • Prostate Cancer Therapeutics

Background:

  • Olaparib, a PARP inhibitor, is effective with hormonal therapy for metastatic prostate cancer with HRR alterations.
  • Its efficacy as monotherapy without androgen deprivation therapy is unknown.

Purpose of the Study:

  • To evaluate olaparib monotherapy's activity in high-risk biochemically recurrent (BCR) prostate cancer post-prostatectomy.

Main Methods:

  • Phase 2, single-arm trial of olaparib (300 mg twice daily) in 51 patients with BCR prostate cancer.
  • Primary endpoint: 50% PSA decline (PSA50). Secondary endpoints: HRR alteration status, safety.

Main Results:

  • 13 of 51 participants (26%) achieved PSA50 response.
  • All 13 responders had HRR-positive tumors, including all 11 with BRCA2 alterations (48% response rate).
  • Common adverse events included fatigue (63%), nausea (55%), and leukopenia (43%).

Conclusions:

  • Olaparib monotherapy demonstrated high, durable PSA50 response rates in patients with BRCA2-altered BCR prostate cancer.
  • Olaparib may be a treatment option for select patients with HRR alterations but lacks efficacy in those without.
  • Further study is warranted for HRR-altered prostate cancer patients.