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Prostate CancerPhase 3NCT03520478

A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer

A Phase 3 study testing SHR3680 and Bicalutamide in people with Prostate Cancer and Hormone-Dependent Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 67 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
SHR3680 and Bicalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
654 participants
Where
67 sitesin 4 countries
Study dates
30 May 2018to 30 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≧18 year, male;
  • ECOG performance scale 0 to 1;
  • Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ;
  • Adequate hepatic, renal, heart, and hematological functions;
  • Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Who cannot join

  • Subject has received any prior radiation therapy or surgery for prostate cancer, except 1 course of palliative surgical therapy if it was used at least 4 weeks prior to day 1;
  • Previous use or are using a second-generation androgen receptor antagonist (enzalutamide, ARN-509, ODM-201), abiraterone, ketoconazole for prostate cancer, or other agents that will inhibit the production of androgens;
  • Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks prior to day 1: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels ;
  • Evidence of brain metastasis or primary tumors;
  • Planned to initiate any other anti-tumor therapies during the study;
  • Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; Clinically significant cardiovascular diseases;
  • History of seizure or certain conditions that may predispose to seizure;
  • Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Trial locations and contacts

67 sites in 4 countries.

67 sites in 4 countries

China49 sites

  • Affiliated Hospital of Hebei University

    Baoding

  • Beijing Cancer Hospital

    Beijing

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • The third hospital of Peking University

    Beijing

  • Tumor Hospital of the Chinese Academy of Medical Sciences

    Beijing

  • China Japan Friendship Hospital of Jilin University

    Changchun

  • The first hospital of Jilin University

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • West China Hospital of Sichuan University

    Chengdu

  • Army characteristic medical center of the Chinese people's Liberation Army

    Chongqing

  • Chongqing Cancer Hospital

    Chongqing

  • The First Affiliated Hospital of Army Medical University

    Chongqing

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • Sun Yat-Sen hospital of Sun Yat-Sen University

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • The First Affiliated Hospital of Zhejiang University Medicine college

    Hangzhou

  • The Second affiliated hospital of zhejiang university medical college

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Zhejiang Province People's Hospital

    Hangzhou

  • Anhui Provincial Hospital

    Hefei

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • Qilu Hospital of Shandong University

    Jinan

  • Yunnan Provincial Cancer Hospital

    Kunming

  • The second hospital of Lanzhou University

    Lanzhou

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Gulou Hospital Affiliated to Medical College of Nanjing University

    Nanjing

  • Jiangsu Provincial Cancer Hospital

    Nanjing

  • Jiangsu Provincial People's Hospital

    Nanjing

  • Huadong Hospital of Fudan University

    Shanghai

  • Ruijin Hospital

    Shanghai

  • Shanghai General Hospital

    Shanghai

  • The Cancer Hospital of Fudan University

    Shanghai

  • Zhongshan Hospital of Fudan University

    Shanghai

  • Liaoning Provincial Cancer Hospital

    Shenyang

  • The fourth hospital of Hebei Medical University

    Shijia Zhuang

  • The second hospital of Tianjin Medical University

    Tianjing

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

  • Hubei Provincial Cancer Hospital

    Wuhan

  • Tongji Hospital, Tongji medical college of HUST

    Wuhan

  • Union Hospital, Tongji Medical college of HUST

    Wuhan

  • Wuxi People's Hospital

    Wuxi

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Jiangsu Subei people's Hospital

    Yangzhou

  • Henan people's Hospital

    Zhengzhou

  • Henan Provincial Cancer Hospital

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

Bulgaria7 sites

  • Complex oncological center - Bourgas

    Burgas

  • UMHAT 'Deva Maria'. EOOD

    Burgas

  • MHAT - Dobrich. AD

    Dobrich

  • MHAT 'Dr. Tota Venkova'. AD

    Gabrovo

  • Complex Oncological Center - Plovdiv. EOOD

    Plovdiv

  • MHAT 'Central Onco Hospital'. OOD

    Plovdiv

  • Acibadem City Clinic Tokuda Hospital Ead

    Sofia

Other trials in Bulgaria

Poland6 sites

  • KO-MED Centra Kliniczne Biala Podlaska

    Biała Podlaska

  • Beskidzkie Centrum Onkologii im.Jana Pawla II

    Bielsko-Biala, Bielsko-Biała

  • Swietokrzyskie Centrum Onkologii

    Kielce

  • Provita Profamilia

    Piotrkow Trybunalski

  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka

    Słupsk

  • LexMedica Osrodek Badan Klinicznych

    Wesoła, Weigla

Other trials in Poland

Czechia5 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno

  • Fakultni nemocnice Olomouc

    Pavlov

  • RESEARCH SITE s.r.o.

    Pilsen, Plzeň

  • Nemocnice Na Homolce

    Prague

  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.

    Ústí nad Labem

Other trials in Czechia

About this study

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

The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.

Read the detailed description

This is an open, multicenter, randomized phase III trial. This clinical study compares the efficacy and safety of SHR3680 with bicalutamide in the patients with hormone sensitive prostate cancer. Approximately 572 patients who meet the entry criteria will be randomly assigned in a 1:1 ratio to SHR3680 or bicalutamide treatment. Primary endpoints of the study are radiological progress-free survival (rPFS) and overall survival (OS).

Being tested
SHR3680, Bicalutamide
Keywords
Hormone sensitive prostate cancer, SHR3680, Anti-androgen receptor
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR3680Drug

    Tablet. Specifications of 80 mg; orally, once a day

  • BicalutamideDrug

    Tablet. Specifications of 50 mg; orally, once a day

Study groups in NCT03520478
Study groupRoleWhat they receive
SHR3680ExperimentalParticipants will receive SHR3680 orally
Receives: Drug: SHR3680
bicalutamideActive comparatorParticipants will receive bicalutamide orally
Receives: Drug: Bicalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rPFS

    Time from randomisation to radiologically confirmed progressive disease or death due to any cause

    Measured: Approximately 70 months

  2. OS

    Time from randomisation to death due to any cause

    Measured: Approximately 70 months

Secondary outcomes (4)

  1. Time to prostate specific antigen (PSA) progression

    Time from randomisation to the first time of PSA progression according to the criterion of PCGW3

    Measured: Approximately 70 months

  2. Time to skeletal-related events

    Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery

    Measured: Approximately 70 months

  3. Objective response rate (ORR)

    The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

    Measured: Approximately 70 months

  4. Time to initiation of a new antineoplastic therapy

    Time from randomisation to the initiation of antineoplastic subsequent to the study treatment

    Measured: Approximately 70 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2018
  2. Study start30 May 2018
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03520478
Sponsor's protocol ID
SHR-3680-III-HSPC
Status last verified
Feb 2021
First submitted
27 Apr 2018
Last updated
2 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu JL, Jiang SS, Luo H, Dong P, Wang ZJ, Xing NZ, Ma T, Wang ZP, Gu XQ, Zhou GC, Xue XY, Sun ZQ, Yang Y, Wang CX, Shan GY, Zhang AL, Ding DG, Wang LP, Duan XH, Wang TT, He T, Lin CY, Zhong XW, Lian JP, Wang WL, Ye DW, Dai B. Impact of hepatotoxicity and lipid metabolism-related toxicity on survival and quality of life in patients with high-volume metastatic hormone-sensitive prostate cancer treated with rezvilutamide in the CHART trial: a post hoc analysis. BMC Med. 2026 Jun 30. doi: 10.1186/s12916-026-04985-8. Online ahead of print.

    PubMed 42380973

  • Wang H, Jiang S, Luo H, Zhou F, He D, Ma L, Guo H, Liang C, Chong T, Jiang J, Chen Z, Wang Y, Zou Q, Tian Y, Xiao J, Huang J, Chen J, Dong Q, Zhang X, Li H, Yang X, Lian J, Wang W, Ye D. 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. Signal Transduct Target Ther. 2024 Dec 18;9(1):351. doi: 10.1038/s41392-024-02064-z.

    PubMed 39690158

  • Bian X, Gu W, Zhang X, Xie L, Wang S, Shi B, Sun T, Wei S, Weng Z, Xia S, Han B, Xu Z, Xing J, Zhang D, Xu D, Du C, He C, Wang Q, Yang X, Lian J, Wang W, Ye D. Correlation of PSA and survival in metastatic hormone-sensitive prostate cancer treated with rezvilutamide plus ADT in the CHART trial. Med. 2025 Feb 14;6(2):100520. doi: 10.1016/j.medj.2024.09.009. Epub 2024 Oct 16.

    PubMed 39419035

  • Gu W, Han W, Luo H, Zhou F, He D, Ma L, Guo H, Liang C, Chong T, Jiang J, Chen Z, Wang Y, Zou Q, Tian Y, Xiao J, Huang J, Zhu S, Dong Q, Zhang X, Li H, Yang X, Chen C, Li J, Jin C, Zhang X, Ye D; CHART Investigators. Rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer (CHART): a randomised, open-label, phase 3 trial. Lancet Oncol. 2022 Oct;23(10):1249-1260. doi: 10.1016/S1470-2045(22)00507-1. Epub 2022 Sep 5.

    PubMed 36075260

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR3680 and Bicalutamide in people with Prostate Cancer and Hormone-Dependent Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 67 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in China, Bulgaria, Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rPFS (time frame: Approximately 70 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03520478, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.

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