GU Cancers 2023 | ROAR study shows promising results for non-metastatic prostate cancer patients with rucaparib

Kamal Sahu, MBBS, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, discusses key takeaways from the ROAR study (NCT03533946), a Phase II single arm investigation of rucaparib for patients with non-metastatic prostate cancer. Eligibility criteria included homologous recombination repair mutations, homologous recombinant mutations, and confirmed non-metastatic status through conventional imaging. 7 patients were enrolled with a median age of 69 and median Gleason score of 7. Of these patients, 3 had BRCA1 or BRCA2 mutations, 2 had ATM mutations, 1 had a RAD51 mutation, and 1 had a RIP1 mutation. 600mg doses were administered twice daily and overall treatment duration was 18 months. The primary endpoint was PSA progression-free survival (PFS), with the secondary endpoints including a 50% PSA reduction, the safety of the drug, and reaching an undetectable PSA level. The results showed an overall PSA PFS of 37.64 months among all 7 patients. 2 patients had stronger responses, achieving PSA ≤50% in initial analyses, before follow-ups found undetectable PSA. Of these 2 patients, 1 had a BRCA2 mutation and 1 had a RAD51 mutation. No serious adverse events (AEs) or toxicity issues were reported, with 2 patients experiencing Grade 3 AEs (anemia and rash). In summary, rucaparib was found to be effective and safe in certain biomarker populations. This interview took place at the ASCO GU Cancers Symposium 2023 in San Francisco, CA.

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