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"A Randomized, Controlled, Multicenter Clinical Study on Irreversible Electroporation for Prostate in Metastatic Prostate Cancer"

"A Randomized, Controlled, Multicenter Clinical Study on Irreversible Electroporation for Prostate in Metastatic Prostate Cancer"

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079897
Enrollment
Unknown
Registered
2024-01-15
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Prostate Cancer

Interventions

experimental group:IRE + NHT
control group:NHT

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: Age 40-85 years. Histologically or cytologically confirmed prostate cancer. Whole-body bone scan (ECT), whole-body MRI, or PET-CT/MRI (FDG/PSMA) confirming the presence of metastatic lesions (bone metastasis or lymph node metastasis). Expected survival >12 months. ECOG performance status score =3. No prior radical surgery or radiation therapy for the primary lesion of prostate cancer. Tumor diameter of the primary prostate tumor =4cm, and no more than 3 lesions. Signed informed consent.

Exclusion criteria

Exclusion criteria: Experienced a seizure within 1 month before enrollment. Histologically or cytologically confirmed prostate neuroendocrine carcinoma. Whole-body MRI or PET-CT/MRI (FDG/PSMA) confirming the presence of visceral metastatic lesions. Presence of second-degree or higher atrioventricular block or a history of cardiac pacemaker implantation. Implantation of electronic devices or metal parts near the ablation area. Absence of anus after rectal or anal surgery or congenital absence of the anus. Contraindications to chemotherapy or hormonal therapy. Deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
DCR;PSA responce rate;BCR;PSA-PFS;rPFS;OS;pain score;function score;IPSS;Qmax;complication rate;

Countries

China

Contacts

Public ContactLiu Ming

Beijing Hospital

liumingbjh@126.com+86 10 8513 6272

Outcome results

None listed

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