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A prospective cohort study comparing the efficacy of neoadjuvant abiraterone +/- docetaxel and radical prostatectomy for locally advanced prostate cancer

A prospective cohort study comparing the efficacy of neoadjuvant abiraterone +/- docetaxel and radical prostatectomy for locally advanced prostate cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045627
Enrollment
Unknown
Registered
2021-04-19
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-12-06

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:abiraterone +/- docetaxel
Control group:None

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1. Prostate acinar adenocarcinoma was diagnosed by prostate biopsy , the clinical stage was locally advanced prostate cancer (pelvic MRI + whole body bone scan to evaluate the clinical stage), CT3a-CT4N0M0 or any CT, N1, M0; 2. Aged 10 years, plan to undergo radical prostatic cancer resection, without obvious surgical contraindications; 4. ECOG score = 90g/L, white blood cells >=3.5 x 10^9/L, and neutrophils >=1.5 x 10^9/L, platelets >=100 x 10^9/L; (2) Creatinine <= 1.0 x upper limit of normal (UNL); and the creatinine clearance rate is greater than 50ml/min; (3) Alanine aminotransferase (ALT) <= 1.5 x upper limit of normal (UNL); Aspartate amino transferase (AST) <= 1.5 x upper limit of normal (UNL); alkaline phosphatase (ALP) <= 1.5 x normal Upper limit (UNL); (4) Total bilirubin (TBIL) <= 1.5 x upper limit of normal (UNL); 6. Cooperate with treatment and follow-up regularly; 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are serious cardiopulmonary and other related diseases, and cannot tolerate surgery or neoadjuvant abiraterone, neoadjuvant chemotherapy or neoadjuvant ADT; 2. Combined with bone or visceral metastasis (M1); 3. Complicated with the following diseases: autoimmune diseases, severe cardiovascular and cerebrovascular diseases, vascular embolism related diseases, severe lung diseases, mental diseases; 4. Suspected or true history of alcohol or drug abuse; 5. Patients who are allergic to abiraterone or docetaxel; 6. Patients who have participated in other clinical trials within the past 3 months; 7. The investigator believes that the patient is not suitable to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
post-operative biochemical progression free survival;

Countries

China

Contacts

Public ContactWang Xuan

Beijing Hospital

alex.wxuan@hotmail.com+86 15201499317

Outcome results

None listed

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