Benign Prostatic Hyperplasia
Conditions
Interventions
Intervention Group:After discontinuing ADT, continue taking finasteride orally at a dose of 5 mg/d in combination with alpha blockers and maintain treatment for 12 months.
Control Group:After discontinuing ADT, only oral alpha blockers were administered and followed up for 12 months.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for Benign Prostatic Hyperplasia (BPH), confirmed by clinical assessment, digital rectal examination (DRE), and imaging. 2. Aged between 50 and 85 years; 3. Prostate volume greater than 40 mL. 4. Present with either absolute or relative surgical indications for BPH. 5. International Prostate Symptom Score (IPSS) >= 15. 6. Maximum urinary flow rate (Qmax) = 4.
Exclusion criteria
Exclusion criteria: 1. Voiding dysfunction caused by neurogenic diseases; 2. Acute urinary tract infection not effectively controlled; 3. Presence of lower urinary tract obstruction factors other than BPH (e.g., urethral stricture, bladder neck contracture, intravesical prostatic protrusion (IPP), etc.); 4. History of radiotherapy or surgery to the lower urinary tract or pelvis; 5. Current diagnosis of urological malignancy under active treatment; 6. Severe hepatic or renal dysfunction (laboratory values outside the reference range); 7. Known allergy or hypersensitivity to leuprorelin (leuprolide) or any excipients used in the drug formulation; 8. Presence of other major uncontrolled systemic diseases (e.g., autoimmune diseases, angina pectoris, heart failure, severe respiratory or digestive diseases, poorly controlled diabetes mellitus, etc.) that have not been clinically resolved; 9. Diagnosis of severe osteoporosis; 10. Any other condition deemed by the investigator as unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score (IPSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Testosterone;Prostate volume;Comprehensive Metabolic Panel (CMP);Complete Blood Count (CBC);Quality of Life(QoL);Urinalysis (UA);Maximum Urinary Flow Rate(Qmax);Standard 12-Lead Electrocardiogram;Prostate-Specific Antigen (PSA); | — |
Countries
China
Contacts
Public ContactJing Yifeng
Shanghai General Hospital
Outcome results
None listed