Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Feb 16;22(1):177.
doi: 10.1186/s12885-022-09276-y.

Efficacy and safety of Androgen Deprivation Therapy (ADT) combined with modified docetaxel chemotherapy versus ADT combined with standard docetaxel chemotherapy in patients with metastatic castration-resistant prostate cancer: study protocol for a multicentre prospective randomized controlled trial

Xiangwei Yang #  1 , Hong Chen #  2 , Duanya Xu  1 , Xianju Chen  1 , Yamei Li  1 , Jun Tian  3 , Dongwen Wang  4 , Jun Pang  5
Affiliations

Efficacy and safety of Androgen Deprivation Therapy (ADT) combined with modified docetaxel chemotherapy versus ADT combined with standard docetaxel chemotherapy in patients with metastatic castration-resistant prostate cancer: study protocol for a multicentre prospective randomized controlled trial

Xiangwei Yang et al. BMC Cancer. .

Abstract

Background: Androgen deprivation therapy (ADT) combined with docetaxel chemotherapy is the standard treatment for metastatic castration-resistant prostate cancer (mCRPC) patients. However, mCRPC patients are mainly frail elderly men, constantly accompanied by comorbidities and showing poor tolerance to standard docetaxel chemotherapy. Some exploratory studies administering modified chemotherapy regimens have reported noninferior oncologic outcomes with fewer adverse events, yet most are retrospective or small studies, and prospective randomized controlled trials have rarely been conducted. Therefore, we designed this modified docetaxel chemotherapy regimen in patients with mCRPC, aiming to evaluate its efficacy and safety compared with the standard docetaxel chemotherapy regimen.

Methods: This is an open-label, multi-institutional, prospective, randomized non-inferiority trial. A total of 128 patients with mCRPC will be randomized to receive ADT combined with modified docetaxel chemotherapy (experimental group, n=64) or ADT combined with standard docetaxel chemotherapy (control group, n=64). Patients in the experimental group will receive a modified regimen with docetaxel 40 mg/m2 on the 1st day and 35 mg/m2 on the 8th day, repeated every 21 days. The primary endpoint is progression-free survival at 2 years. Secondary endpoints include overall survival, prostate-specific antigen response rate, pain response rate, toxicity and quality of life.

Discussion: The expected benefit for the patient in the experimental arm is noninferior efficacy with decreased toxicity and improved quality of life compared with that in the control arm. To the best of our knowledge, this will be the first multicentre prospective randomized study to assess the efficacy and safety of modified docetaxel chemotherapy in patients with mCRPC in China. The results of this trial may provide benefit to mCRPC patients, especially those with poor performance.

Trial registration: chictr.org.cn Identifier: ChiCTR2100046636 (May 24, 2021). Ongoing study.

Keywords: Androgen deprivation therapy; Metastatic castration-resistant prostate cancer; Modified docetaxel chemotherapy.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study. ADT: Androgen deprivation therapy; PSA: Prostate-specific antigen; QoL: Quality of life; CT: Computed tomography; MRI: Magnetic resonance imaging
See this image and copyright information in PMC

References

    1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. - PubMed
    1. Culp MB, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. Recent global patterns in prostate cancer incidence and mortality rates. Eur Urol. 2020;77(1):38–52. - PubMed
    1. Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, et al. Cancer statistics in China, 2015. CA Cancer J Clin. 2016;66(2):115–32. doi: 10.3322/caac.21338. - DOI - PubMed
    1. Qi D, Wu C, Liu F, Gu K, Shi Z, Lin X, et al. Trends of prostate cancer incidence and mortality in Shanghai, China from 1973 to 2009. Prostate. 2015;75(14):1662–8. - PubMed
    1. Seraphin TP, Joko-Fru WY, Kamaté B, Chokunonga E, Wabinga H, Somdyala NIM, et al. Rising prostate cancer incidence in sub-Saharan Africa: a trend analysis of data from the African Cancer Registry Network. Cancer Epidemiol Biomarkers Prev. 2021;30(1):158–65. - PubMed

Publication types

MeSH terms

LinkOut - more resources