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The value of ultrasound elastography combined with the distribution of body fat and muscle in evaluating the efficacy of neoadjuvant therapy for prostate cancer

The value of ultrasound elastography combined with the distribution of body fat and muscle in evaluating the efficacy of neoadjuvant therapy for prostate cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062729
Enrollment
Unknown
Registered
2022-08-16
Start date
2022-08-15
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Prostate cancer

Interventions

Index test:Ultrasound&#32
combined&#32
with&#32
and&#32
distribution

Sponsors

Department of urology, The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who were clinically diagnosed with prostate cancer and met the conditions of neoadjuvant therapy, the conditions were as follows: (1) Locally advanced prostate cancer at initial diagnosis (stage T3~T4 or stage N of any T stage); (2) According to the 2021 National Comprehensive Cancer Network (NCCN) Clinical guidelines for prostate cancer risk classification, patients were classified as extremely high risk at initial diagnosis [at least one of the following must be met: STAGE T3b to T4; Gleason score 5 in the major grading area of prostate cancer tissue; puncture > 4 needles were classified into 4 or 5 groups according to ISUP grading; biopsy > 4 needles were classified into 4 or 5 groups according to ISUP grading. Characteristics of more than 2 high-risk groups]; (3) No distant metastasis was confirmed by whole-body bone imaging or positron emission tomography/computed tomography (PET/CT) at initial diagnosis. 2. Patients who underwent ultrasound elastography and body fat muscle distribution testing before receiving neoadjuvant therapy; 3. Complete clinicopathological data; 4. ECOG physical fitness status score 0-2; 5. Male patients aged 18 to 75 years; 6. Function of major organs: liver, kidney, bone marrow, heart and other important organs have no obvious abnormality; 7. The subject must have the ability to understand and sign the informed consent voluntarily, and the informed consent must be signed before any test procedures; 8. No malignant tumors other than prostate cancer were found at initial diagnosis.

Exclusion criteria

Exclusion criteria: 1. Abnormal coagulation mechanism; 2. Patients who had received other adjuvant chemotherapy such as chemotherapy, radiotherapy and immunotherapy before neoadjuvant therapy; 3. Have a history of severe allergic reactions to chemotherapy drugs and contrast agents; 4. acute infection of urinary system; 5. Serious organ dysfunction, such as serious abnormality of heart, lung, liver and kidney; 6. Incomplete data and information collection; 7. persons suffering from diseases or infections related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 8. Patients who abuse alcohol or narcotic drugs, have a history of drug abuse, or have a history of mental illness; 9. Patients who cannot cooperate with relevant examinations of this project and do not agree to sign informed consent; 10. Patients with the following symptoms within 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack; 11. Patients with persistent arrhythmia grade >= 2 (NCI CTCAE Version 4.0 grade); 12. Patients with claustrophobia.

Design outcomes

Primary

MeasureTime frame
Body Mass Index (BMI);Elastography;Skeletal Muscle Index (SMI);Skeletal Muscle Density(SMD);Subcutaneous Fat Area (SFA);Visceral Fat Area (VFA);Periprostatic Fat Area (PPFA);Periprostatic Fat Area/Prostate Area(PPFA/PA);Periprostatic Fat Thickness/Subcutaneous Fat Thickness (PPFT/SFT);Waist Circumference(WC);Hip circumferenc(HC);Waist-hip ratio(WHR);Subcutaneous Fat Index(SFI);Subcutaneous Fat Thickness(SFT);Visceral Fat Index(VFI);

Countries

China

Contacts

Public ContactNing Xu
drxun@fjmu.edu.cn+86 13235907575

Outcome results

None listed

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