Evidence map›Paper›PMID 39690158›Full record

Trial reportSignal transduction and targeted therapy2024

Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 study.

Hongkai Wang, Shusuan Jiang, Hong Luo, Fangjian Zhou, Dalin He, Lulin Ma, Hongqian Guo, Chaozhao Liang, Tie Chong, Jun Jiang and 14 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03520478 (A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

NCT03520478 phase3unknown statusnot on this map

A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2018 to 2025Enrolled654ConditionsProstate Cancer, Hormone-Dependent Prostate CancerArmsSHR3680, Bicalutamide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

24 authors.

Hongkai WangDepartment of Urology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China.
Shusuan JiangUrology Surgery, Hunan Cancer Hospital, Changsha, China.
Hong LuoDepartment of Urology, Chongqing University Cancer Hospital, Chongqing, China.
Fangjian ZhouUrology Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.
Dalin HeUrology Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Lulin MaUrology Surgery, Peking University Third Hospital, Beijing, China.
Hongqian GuoDepartment of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Chaozhao LiangDepartment of Urology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Tie ChongUrology Surgery, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Jun JiangDepartment of Urology, Army Medical Center of PLA, Chongqing, China.
Zhiwen ChenDepartment of Urology, The First Affiliated Hospital of the Army Medical University, Chongqing, China.
Yong WangDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.
Qing ZouDepartment of Urology, Jiangsu Cancer Hospital, The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Institute of Cancer Research, Nanjing, China.
Ye TianUrology Surgery, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, China.
Jun XiaoDivision of Life Sciences and Medicine, Department of Urology, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, China.
Jian HuangUrology Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Jinchao ChenDepartment of Urology, Zhejiang Cancer Hospital, Hangzhou, China.
Qiang DongDepartment of Urology, West China Hospital of Sichuan University, Chengdu, China.
Xiaoping ZhangUrology Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Hanzhong LiUrology Surgery, Peking Union Medical College Hospital, Beijing, China.
Xinfeng YangDepartment of Biometrics, Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shanghai, China.
Jianpo LianClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shanghai, China.
Wenliang WangClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shanghai, China.
Dingwei YeDepartment of Urology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China. dwyeli@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The randomized phase 3 CHART trial (NCT03520478) revealed that rezvilutamide (REZ) plus androgen deprivation therapy (ADT) in high-volume, metastatic, hormone-sensitive prostate cancer (mHSPC) significantly enhanced radiographic progression-free and overall survival than bicalutamide (BIC)-ADT. Accordingly, we examined patient-reported outcomes (PROs) results, which were exploratory endpoints in the CHART trial. The patients were randomly allocated to receive REZ-ADT or BIC-ADT in a 1:1 ratio. The PROs were evaluated with the Brief Pain Inventory-Short Form (BPI-SF) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaires. Both study groups displayed comparable baseline pain scores and functional status. Patients administered REZ-ADT had an extended time to progression of worst pain intensity in comparison to those treated with BIC-ADT (25th percentile, 9.2 [95% CI 7.4-16.6] vs. 6.4 months [95% CI 5.5-8.3]; HR 0.75 [95% CI 0.57-0.97]; p = 0.026). Similarly, patients received REZ-ADT exhibited a delayed time to progression of pain interference in comparison to those receiving BIC-ADT (25th percentile, 20.2 [95% CI 12.9-31.3] vs. 10.2 months [95% CI 7.4-11.1]; HR 0.70 [95% CI 0.52-0.93]; p = 0.015). Additionally, the REZ-ADT group demonstrated a prolonged delay in the deterioration of the total score on the FACT-P questionnaire (25th percentile, 12.8 [95% CI 7.4-20.3] vs. 6.0 months [95% CI 4.6-9.2]; HR 0.66 [95% CI 0.50-0.86]; p = 0.002), as well as most of the FACT-P subscale scores, in comparison to the BIC-ADT group. In conclusion, REZ-ADT is superior to BIC-ADT regarding the pain alleviation and enhancement of functional scales for high-volume mHSPC.

Indexed as

Androgen AntagonistsAnilidesNitrilesPatient Reported Outcome MeasuresProstatic NeoplasmsTosyl CompoundsAgedAntineoplastic Combined Chemotherapy ProtocolsHumansMaleMiddle AgedNeoplasm MetastasisAndrogen AntagonistsAnilidesbicalutamideNitrilesTosyl Compounds

Identifiers

PMID39690158
PMCPMC11652652

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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.