{"doi":"10.1093/oncolo/oyae120","title":"TRIUMPH: phase II trial of rucaparib monotherapy in patients with metastatic hormone-sensitive prostate cancer harboring germline homologous recombination repair gene mutations","abstract":"BACKGROUND: The activity of PARP inhibitors (PARPi) in patients with homologous recombination repair (HRR) mutations and metastatic castration-resistant prostate cancer has been established. We hypothesized that the benefit of PARPi can be maintained in the absence of androgen deprivation therapy (ADT) in an HRR-mutated population. We report the results of a phase II clinical trial of rucaparib monotherapy in patients with metastatic hormone-sensitive prostate cancer (mHSPC). METHODS: This was a multi-center, single-arm phase II trial (NCT03413995) for patients with asymptomatic, mHSPC. Patients were required to have a pathogenic germline mutation in an HRR gene for eligibility. All patients received rucaparib 600 mg by mouth twice daily, without androgen deprivation. The primary endpoint was a confirmed PSA50 response rate. RESULTS: Twelve patients were enrolled, 7 with a BRCA1/2 mutation and 5 with a CHEK2 mutation. The confirmed PSA50 response rate to rucaparib was 41.7% (N = 5/12, 95% CI: 15.2-72.3%, one-sided P = .81 against the 50% null), which did not meet the pre-specified efficacy boundary to enroll additional patients. In patients with measurable disease, the objective response rate was 60% (N = 3/5), all with a BRCA2 mutation. The median radiographic progression-free survival on rucaparib was estimated at 12.0 months (95% CI: 8.0-NR months). The majority of adverse events were grade ≤2, and expected. CONCLUSION: Rucaparib can induce clinical responses in a biomarker-selected metastatic prostate cancer population without concurrent ADT. However, the pre-specified efficacy threshold was not met, and enrolment was truncated. Although durable responses were observed in a subset of patients, further study of PARPi treatment without ADT in mHSPC is unlikely to change clinical practice.","journal":null,"year":2024,"id":433106,"datarank":0.6870831376359576,"base_score":2.70805020110221,"endowment":2.70805020110221,"self_citation_contribution":0.40620753016533157,"citation_network_contribution":0.2808756074706261,"self_endowment_contribution":0.40620753016533157,"citer_contribution":0.2808756074706261,"corpus_percentile":null,"corpus_rank":null,"citation_count":14,"citer_count":13,"citers_with_citation_signal":10,"citers_with_endowment":10,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9586,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03413995"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":553767,"name":"Cora N. Sternberg","orcid":"0000-0003-3938-2627","position":1,"is_corresponding":false},{"id":277001,"name":"Hao Wang","orcid":"0000-0001-6489-6940","position":2,"is_corresponding":false},{"id":905263,"name":"Tingchang Wang","orcid":"0000-0002-2377-9606","position":3,"is_corresponding":false},{"id":363533,"name":"Laura Linville","orcid":"0000-0001-6993-3421","position":4,"is_corresponding":false},{"id":479688,"name":"Catherine H. Marshall","orcid":"0000-0002-2653-4110","position":5,"is_corresponding":false},{"id":650524,"name":"Rana Sullivan","orcid":null,"position":6,"is_corresponding":false},{"id":654156,"name":"Serina King","orcid":null,"position":7,"is_corresponding":false},{"id":323563,"name":"Tamara L. Lotan","orcid":"0000-0002-0494-9067","position":8,"is_corresponding":false},{"id":272258,"name":"Emmanuel S. Antonarakis","orcid":"0000-0003-0031-9655","position":9,"is_corresponding":false},{"id":334087,"name":"Mark C. Markowski","orcid":"0000-0003-2780-5100","position":0,"is_corresponding":true}],"reference_count":24,"raw_metadata":null,"created_at":"2026-07-19T01:59:44.444627Z","pmid":"38885246","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}