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Clinical Study on Fuzheng Yiliu Formula Delaying the Progress of Metastatic Hormone-sensitive Prostate Cancer

Clinical Study on Fuzheng Yiliu Formula Delaying the Progress of Hormone-sensitive Prostate Cancer Based on Androgen Receptor Signal Pathway

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068642
Enrollment
Unknown
Registered
2023-02-27
Start date
2023-02-27
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostatic cancer

Interventions

Test group:Fuzheng Yiliu Formula+Endocrine Therapy
General group:Endocrine therapy

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. The patients with prostate cancer were confirmed as mHSPC according to the pathological results of prostate biopsy under the guidance of B-ultrasound and combined with imaging examination; 2. In line with the diagnostic criteria for castrated prostate cancer in the "Consensus of Experts on the Diagnosis and Treatment of Castrated Prostate Cancer in China" formulated by the Urinary Cancer Professional Committee of the Chinese Anti-Cancer Association in July 2016: (1) Serum testosterone reached the level of castration (2 ug/L Or imaging progress: 2 or more new lesions or soft tissue lesions meeting the evaluation criteria for solid tumor response were found on bone scan. 3. TCM syndrome differentiation refers to the revised Guidelines for the Diagnosis and Treatment of Prostate Cancer by Chinese and Western Medicine of the internal urology department of the applicant unit in 2017, which conforms to the following TCM symptoms: poor urination, weak urination, thin urination line, frequent nocturnal urination, or fullness of the lower abdomen, or even painless urination, and sometimes hematuria; The waist and knees are sore and weak, the spirit is tired and weak, and there is little gas and lazy talk, which can be accompanied by bone pain all over the body; The tongue is purple and dark or has ecchymosis, the coating is slightly greasy or less, and the pulse is thin, astringent or heavy. 4. Adhere to the treatment plan and follow up; 5. Those who voluntarily sign the informed consent form and voluntarily participate in the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients with other tumor types or combined with other tumors except adenocarcinoma; 2. Patients with central nervous system metastasis or diseases of heart, brain, liver, kidney and hematopoietic system and mental patients; 3. Allergic constitution or allergic to traditional Chinese medicine decoction; 4. Not willing to sign the written informed consent; 5. Participate in other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
Prostate specific antigen;

Secondary

MeasureTime frame
serum free testosterone;routine blood test;liver function;kidney function;

Countries

The People's Republic of China

Contacts

Public ContactGANSHU

Guangdong Provincial Hospital of Traditional Chinese Medicine

rain11125@163.com02081887233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026