Evidence map›Paper›PMID 42115448›Full record

Trial reportWorld journal of urology2026

Olaparib combined with abiraterone in HRR-mutated metastatic hormone-sensitive prostate cancer: a single-arm phase II trial.

Xuyu Zhang, Zhigang Wu, Lingling Hao, Xuefeng Qiu, Linfeng Xu, Shun Zhang, Hongqian Guo, Junlong Zhuang

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05167175 (A Single-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05167175 phase2unknown statusnot on this map

A Single-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation

TypeinterventionalSponsorHongqian GuoRan2022 to 2024Enrolled30ConditionsProstate Cancer, Prostate Carcinoma, Metastatic Prostate CancerArmsOlaparib tablet, Abiraterone acetate, Prednisone tablet
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Xuyu Zhang *Department of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Zhigang Wu *Department of Urology, Nanjing Drum Tower Hospital Clinical College of Nanjing University of Chinese Medicine, Nanjing, China.
Lingling Hao *Department of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Xuefeng QiuDepartment of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Linfeng XuDepartment of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Shun ZhangDepartment of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China. explorershun@126.com.
Hongqian GuoDepartment of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China. dr.ghq@nju.edu.cn.
Junlong ZhuangDepartment of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China. zhuangjl@nju.edu.cn.

Funding

Nanjing Health Technology Development, Project Foundation for Distinguished Young Scholars JQX23001National Natural Science Foundation of China 82273301Natural Science Foundation of Jiangsu Province BE2020622Natural Science Foundation of Jiangsu Province for Distinguished Young Scholars BK20240018The Sino-German Mobility Programme M-0670
6 · The paper itself

Abstract

purposeAlthough olaparib plus abiraterone and prednisone has significantly prolonged radiographic progression-free survival (rPFS) in metastatic castration resistant prostate cancer patients (mCRPC), little is known about the effects of this combination therapy on metastatic hormone-sensitive prostate cancer (mHSPC), especially for those with homologous recombination repair (HRR) genes. We conducted a phase II clinical trial to evaluate the efficacy and safety of olaparib plus abiraterone for mHSPC with HRR gene mutations.

methodsThirty patients with mHSPC who had at least one HRR gene mutation were enrolled. Patients were administered Olaparib 300 mg BID plus abiraterone 1000 mg QD and prednisone 5 mg QD. The primary endpoint was 1-year rPFS rate per PCWG3-modified RECIST 1.1 by investigator assessment, and the secondary endpoints included median rPFS, PSA response rate, PSA-PFS, ORR.

resultsA total of 30 patients administered combination therapy with mutations in 7 HRR genes. All the patients had de novo mHSPC. The median follow-up was 19.0 months. The 1-year rPFS rate was 77.7% (95% CI: 63.4-95.3%). All patients achieved PSA50 response. Among the 13 patients who had measurable disease at baseline, the confirmed ORR was 84.6% (n = 11). One patient achieved a complete response, ten patients obtained a partial response, and two had progressive disease. The treatment was well tolerated, with 8(26.6%) patients experienced≥ grade 3 treatment-related adverse events (TRAEs). Common TRAE was anemia (13 patients, 43.3%).

conclusionIn this phase II single-arm study, olaparib plus abiraterone and ADT showed preliminary activity and a manageable safety profile in patients with HRR-mutated mHSPC, but these findings need to be confirmed in larger phase III studies.

trial registrationThis trial is registered with ClinicalTrials.gov, number NCT05167175.

Indexed as

AndrostenesAntineoplastic Combined Chemotherapy ProtocolsPhthalazinesPiperazinesProstatic NeoplasmsRecombinational DNA RepairAgedHumansMaleMiddle AgedMutationNeoplasm MetastasisabirateroneAndrostenesolaparibPhthalazinesPiperazinesAbirateroneHRR gene mutationmetastatic hormone-sensitive prostate cancerOlaparibradiographic progression-free survival

Identifiers

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.