To investigate the clinical effect and ctDNA dynamic change of 'Jianpi Lishi Huayu Decoction' on the 'maximum androgen blocking' of advanced prostate cancer

Registration number:

ITMCTR2100004818

Date of Last Refreshed on:

2021-05-08

Date of Registration:

2021-05-08

Registration Status:

Prospective registration

Public title:

To investigate the clinical effect and ctDNA dynamic change of 'Jianpi Lishi Huayu Decoction' on the 'maximum androgen blocking' of advanced prostate cancer

English Acronym:

Scientific title:

To investigate the clinical effect and ctDNA dynamic change of 'Jianpi Lishi Huayu Decoction' on the 'maximum androgen blocking' of advanced prostate cancer

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100046172 ; ChiMCTR2100004818

Applicant:

Lu Ying

Study leader:

Li Xiaojiang

Applicant telephone:

+86 17320265178

Study leader's telephone:

+86 13820639756

Applicant Fax:

Study leader's fax:

Applicant E-mail:

1223952865@qq.com

Study leader's E-mail:

zxqlovelxj@126.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

88 Changling Road, Xiqing District, Tianjin

Study leader's address:

88 Changling Road, Xiqing District, Tianjin

Applicant postcode:

Study leader's postcode:

Applicant's institution:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

TYLL2021[K]字 020

Approved file of Ethical Committee:

View

Name of the ethic committee:

IRB of the First Teaching Hospital of Tianjin University of TCM

Date of approved by ethic committee:

2021/2/2 0:00:00

Contact Name of the ethic committee:

Jia Jingyun

Contact Address of the ethic committee:

88 Changling Road, Xiqing District, Tianjin

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Primary sponsor's address:

88 Changling Road, Xiqing District, Tianjin

Secondary sponsor:

Country:

China

Province:

Tianjin

City:

Institution
hospital:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Address:

88 Changling Road, Xiqing District

Source(s) of funding:

self-financing

Target disease:

Prostate Cancer

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

To investigate the clinical effect and ctDNA dynamic change of "Jianpi-Lishi-Huayu Decoction" on the "maximum androgen blocking" of advanced prostate cancer. To observe the effect of traditional Chinese medicine "Jianpi-Lishi-Huayu Decoction" combined with MAB therapy on adverse reactions of MAB and quality of life of patients with advanced prostate cancer, and to find the effective target of traditional Chinese medicine.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Male, in line with the Western medical diagnostic criteria of Diagnostic Criterion for Prostate Cancer, confirmed as prostate cancer by biopsy and puncture, and not complicated with neuroendocrinization, signet ring cell or small cell characteristics; 2. Meet the American Joint Committee on Cancer (AJCC) 8th edition TNM staging criteria for prostate cancer, which are T3-4, N0-1, M0-1; 3. Diagnostic criteria of traditional Chinese medicine: with reference to the teaching material of TCM oncology (dai-han zhou editor, guangzhou higher education press, 2007) and the standard of China association of Chinese medicine tumor diagnosis and treatment of traditional Chinese medicine guide (2008) and the malignant tumor diagnosis and treatment of traditional Chinese medicine guide (hong-sheng Lin editor, people's medical publishing house, 2014), the state bureau of technical supervision issued term in the clinical diagnosis and treatment of TCM syndrome part "(1997). 4. No previous endocrine therapy related to prostate cancer; 5. According to Zubrod-Ecog-WHO (ZPS, 5-point method) scoring criteria, the baseline assessment of patients before enrolment should meet 0-2 points; 6. Bone marrow hematopoietic function was not significantly impaired (WBC >= 3.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 90g/L); 7. Biochemical examination shall meet the following standards: 1) TBIL < 1.5 x ULN; 2) ALT and AST < 2 ULN (<= 5 x ULN if abnormal liver function is caused by liver metastasis); 3) Serum Cr acuities were 1.25 x ULN or endogenous creatinine clearance > 45 ml/min (Cockcroft - Gault formula); 4) Coagulation function should meet the following criteria: INR <= 1.5 and APTT <= 1.5 x ULN; 8. The expected survival time is not less than 12 weeks; 9. Patients volunteered to participate in this study with good compliance, can cooperate with treatment and observation, and sign informed consent form (ICF).

Exclusion criteria:

1. Combined with serious primary diseases of the heart, brain, liver and hematopoietic system or with other cancers; 2. Combined with renal injury due to spinal cord compression or urinary tract obstruction, or who are at risk of developing this phenomenon; 3. Allergic to carlutamine or any component of the preparation;Have a history of allergy to goserrelin acetate/leproterreli; 4. Combined with central nervous system disorders or mental disorders, with a clear history of previous neurological or mental disorders, including epilepsy or dementia; 5. Factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction); 6. Participated in other clinical trials within the last 3 months;n acetate preparation ingredients, synthetic LH-RH or LH-RH derivatives; 7. The Investigator believes that there is any condition that may harm the subject or cause the subject to fail to meet or perform the study requirements; 8. Increases the risk of participating in the study or of the study drug and, in the investigator's judgment, may result in a serious disease or non-tumor comorbidity that would ineligible the patient for inclusion in the study; 9. Failed to comply with the protocol; 10. Unsuitable for inclusion by attending physicians.

Study execute time:

From 2021-05-08

To      2022-05-31

Recruiting time:

From 2021-05-08

To      1990-01-01

Interventions:

50

Group:

control group

Sample size:

Intervention:

Bicalutamine And Goserrelin Acetate/Leprorelin Acetate

Intervention code:

50

Group:

treatment group

Sample size:

Intervention:

Traditional Chinese Medicine Combined With Bicalutamine And Goserrelin Acetate/Leprorelin Acetate

Intervention code:

Total sample size : 100

Countries of recruitment
and research settings:

Country:

China

Province:

Tianjin

City:

Institution/hospital:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

Country:

China

Province:

Tianjin

City:

Institution/hospital:

General Hospital of Tianjin Medical University

Level of the institution:

Tertiary A

Outcomes:

Outcome:

CT/MRI

Type:

Secondary indicator

Measure time point of outcome:

Before the start of the experiment, 24 weeks after treatment

Measure method:

Outcome:

ISS

Type:

Primary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

coagulation four indices

Type:

Secondary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

TCM clinical symptom scoring

Type:

Primary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

KPS

Type:

Primary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

ECT

Type:

Secondary indicator

Measure time point of outcome:

Before the start of the experiment, 24 weeks after treatment

Measure method:

Outcome:

Liver and kidney function

Type:

Secondary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

Serum free testosterone

Type:

Secondary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

EORTC QLQ-C30

Type:

Primary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

blood routine examination

Type:

Secondary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

International Prostate Symptom Score

Type:

Primary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Outcome:

tPSA

Type:

Primary indicator

Measure time point of outcome:

Before the start of the experiment, 12 weeks after treatment, 24 weeks after treatment

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Blood

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

18
Min age years
85
Max age years

Recruiting status:

Participant age:

Gender:

Male

Randomization Procedure (please state who generates the random number sequence and by what method):

In the random method, the method of minimizing dynamic randomness was used.

Blinding:

Not stated

IPD sharing:

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

ResMan, http://www.medresman.org.cn.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

EDC

Data Managemen Committee:

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above