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Prostate arterial embolization with drug-eluting microspheres for inoperable prostate sarcoma

Prostate arterial embolization with drug-eluting microspheres for inoperable prostate sarcoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029233
Enrollment
Unknown
Registered
2020-01-19
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-20

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

Conditions

Prostate sarcoma

Interventions

Drug-eluting microspheres:HepaSphere was loaded with doxorubicin to embolize tumor blood vessels with a drug-loaded embolization microsphere
PVA granules:Doxorubicin was slowly perfused through the prostatic artery and then embolized with PVA granules (pva-100)

Sponsors

Department of Interventional Radiology, the First Medical Center, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male aged >= 18; 2. Histopathologically diagnosed as prostate sarcoma with clinical stage T3-4N0M0; 3. Not suitable for local treatment such as radical surgery and/or radiotherapy, or disease progression after local treatment such as surgery and/or radiotherapy; 4. The patient can receive drug treatment in the past, but the disease progresses after drug treatment; 5. According to the efficacy evaluation criteria for solid tumors 1.1 (RECIST V1.1), there was at least one measurable lesion; 6. ECOG physical condition score: 0 or 1; 7. Expected survival time >= 12 weeks.

Exclusion criteria

Exclusion criteria: 1. Severe urinary tract infection (active phase); 2. Allergic to iodine contrast agent; 3. Refractory massive ascites; 4. ECOG physical condition score of 2 or above; 5. Those who cannot cooperate with mental disorders; 6. It is not expected to complete the postoperative follow-up; 7. Have uncontrolled clinically significant disease.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
PFS;1 year, 2 year survival rate;Improvement in living conditions;Success rate of surgical transformation;

Countries

China

Contacts

Public ContactWang Maoqiang

The First Medical Center, Chinese PLA General Hospital

wangmq@vip.sina.com+86 13910531926

Outcome results

None listed

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