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Study on the Safety and Efficacy of Abiraterone Acetate Tablets (II) as Neoadjuvant Therapy for Newly Diagnosed Locally Advanced Prostate Cancer

Study on the Safety and Efficacy of Abiraterone Acetate Tablets (II) as Neoadjuvant Therapy for Newly Diagnosed Locally Advanced Prostate Cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125584
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Localized advanced prostate cancer

Interventions

Treatment group:Abiraterone treatment + Radical prostatectomy

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. The prostate biopsy diagnosis was prostatic acinar adenocarcinoma, with clinical stage T3b - T4NxM0 or TxN1M0. 2. Age is less than or equal to 85 years old. 3. Expected lifespan is over 10 years. The patient intends to undergo radical prostate cancer resection surgery and there are no obvious surgical contraindications. 4. ECOG score = 70g/L, white blood cell >= 3.5×10^9/L, and neutrophil >= 1.5×10^9/L; b) Creatinine <= 1.5× upper limit of normal (UNL); c) Alanine aminotransferase (ALT) <= 1.5× UNL; aspartate aminotransferase (AST) <= 1.5× UNL; alkaline phosphatase (ALP) <= 1.5× UNL; d) Total bilirubin (TBIL) <=2.5× UNL.

Exclusion criteria

Exclusion criteria: 1. There are serious heart and lung-related diseases, and one is unable to withstand surgery or chemotherapy. 2. Metastasis of bone or internal organs (M1); 3. Metastasis of bone or internal organs (M1) combined with the following diseases: autoimmune diseases, infectious diseases (HIV, HBV, HCV), severe cardiovascular and cerebrovascular diseases (history of previous myocardial infarction, cerebral infarction), thrombosis-related diseases, interstitial pneumonia; 4. Suspected or with a confirmed history of alcohol or drug abuse; 5. Those who are allergic to this experimental drug and its components.

Design outcomes

Primary

MeasureTime frame
No biochemical resuscitation survival time;

Secondary

MeasureTime frame
Radiographic Progression-Free Survival (rPFS);Incidence of adverse reactions;Treat the root cause of the disease and the rates of CR and MRD;

Countries

China

Contacts

Public ContactHou Huimin

Beijing Hospital

houhuimin0305@163.com+86 10 8513 6272

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026