Prostate Cancer
Conditions
Interventions
Experimental group(mHSPC):Prostate artery infusion chemotherapy (docetaxel 45 mg/m2) plus prostatic artery embolization (docetaxel-eluting beads) was performed, and ADT combined with ARPI therapy was
Experimental group(mCRPC):Prostate artery infusion chemotherapy (docetaxel 45 mg/m2) plus prostatic artery embolization (docetaxel-eluting beads) was performed, and ADT combined with ARPI therapy was
Sponsors
The Second Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1:mHSPC Subgroup: 1)Male, aged 18–80 years, with a life expectancy of >=12 months; 2)Histopathologically confirmed prostate adenocarcinoma; 3)Diagnosed as high-risk mHSPC according to the LATITUDE criteria; 4)Primary lesion has not received prior treatment; 5)Refusal of systemic chemotherapy and other surgical treatments based on adequate informed consent; 6)Able to provide written informed consent. Patients who meet all of the above criteria may be enrolled as subjects in the mHSPC subgroup. Note: Definition of high-risk mHSPC according to the LATITUDE criteria: at least two of the following — Gleason score =8; =3 bone metastases; presence of measurable visceral metastases. 2: mCRPC Subgroup: 1)Male, aged 18–80 years, with a life expectancy of >=12 months; 2)Histopathologically confirmed prostate adenocarcinoma; 3)Diagnosed as mCRPC according to the PCWG3 criteria; 4)Refusal of systemic chemotherapy and other surgical treatments based on adequate informed consent; 5)Able to provide written informed consent. Patients who meet all of the above criteria may be enrolled as subjects in the mCRPC subgroup. Note: Definition of mCRPC according to the PCWG3 criteria: 1)Serum testosterone concentration at castration level (50% above the nadir, with an absolute PSA value of >=2 ng/mL; 3)Radiographic progression while on continuous endocrine therapy, defined as definite progression of measurable lesions (lymph nodes, viscera) — i.e., a >=20% increase in the sum of the target lesion diameters, or the appearance of new lesions — or the appearance of >=2 new lesions on bone scan; 4)Disease progression is consistent with clinical deterioration, supported by corresponding clinical features (e.g., worsening symptoms, declining performance status, etc.), and PSA elevation due to non-tumor factors has been excluded.
Exclusion criteria
Exclusion criteria: 1)Have received radiotherapy or systemic chemotherapy; 2)Karnofsky Performance Scale (KPS) score <60; 3)Severe cardiopulmonary dysfunction or coagulation abnormalities; 4)Neurological dysfunction or cognitive impairment; 5)Active infection; 6)Presence of iodine allergy, renal insufficiency, or contraindications to angiography; 7)Presence of severe atherosclerosis, iliac artery or prostatic artery tortuosity; 8)Currently participating in another clinical trial, or having participated in another clinical trial with less than one year since completion; 9)Judged by the investigator to be unsuitable for participation in this clinical trial. Patients who meet any of the above criteria will not be enrolled as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA50 response rate;Deep PSA remission rate;Overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Median survival;PSA50 response rate;Deep PSA remission rate;Change in serum alkaline phosphatase (ALP) level;Time from mHSPC progression to mCRPC;Change in prostate volume;Radiographic progression-free survival (rPFS);Degree of improvement in voiding symptoms / Lower urinary tract symptoms (LUTS) improvement; | — |
Countries
China
Contacts
Public ContactShancheng Ren
The Second Affiliated Hospital of Naval Medical University
Outcome results
None listed