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Prospective study of epirubicin loaded microspheres in the treatment of advanced prostate cancer

Prospective study of epirubicin loaded microspheres in the treatment of advanced prostate cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047378
Enrollment
Unknown
Registered
2021-06-13
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-02-07

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

Conditions

prostatic cancer

Interventions

experimental group:CalliSpheres loaded with drug-loaded microspheres and epirubicin

Sponsors

Meizhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Prostate cancer is confirmed by puncture or electrotomy specimen; 2. IPSS score>7 points, QOL score>3 points, KPS score above 60 points; 3. Patients with hormone-sensitive prostate cancer who refuse surgery or endocrine therapy; 4. Patients with acute lower urinary tract obstruction and hematuria will be selected, those with obvious symptoms and no acute symptoms should be treated with hormone medication for at least 4 weeks, residual urine volume > 50mL, and radiotherapy should be stopped for at least 3 months to achieve CRPC; 5. Prostate volume>25mL; 6. Bone marrow hematopoietic function is not significantly impaired (white blood cells >= 3.5x10^9/L, platelets >=100x10^9/L, hemoglobin >= 90.0 g/L), liver and kidney functions are basically normal; 7. The conditions of bilateral iliac vessels can satisfy the operation; 8. The patient has good compliance, can cooperate with treatment and facilitate observation; 9. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Received other radiotherapy or chemotherapy three months before enrollment; 2. Physical function: KPS score less than 60 points; 3. Heart, liver, and kidney dysfunction (heart function grade III and above; AST and/or ALT > 4 times the upper limit of normal; creatinine > 2mg/L); 4. Patients with neurological dysfunction or cognitive impairment; 5. Patients with active infections; 6. TACE, epirubicin contraindications; 7. Patients with poor compliance such as floating population; 8. Participants in clinical trials of other experimental drugs or devices within four weeks.

Design outcomes

Primary

MeasureTime frame
International prostate symptom score;Patient residual urine volume;Maximum urine flow;

Countries

China

Contacts

Public ContactChen Nanhui

Meizhou People's Hospital

gdmzzgb@163.com+86 13823880488

Outcome results

None listed

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