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Neoadjuvant Chemohormonal With Abiraterone in High-risk Localized Prostate Cancer: A Single-Center Prospective Randomized Controlled Study

Neoadjuvant Chemohormonal With Abiraterone in High-risk Localized Prostate Cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058128
Enrollment
Unknown
Registered
2022-03-30
Start date
2021-12-13
Completion date
Unknown
Last updated
2023-12-03

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:neoadjuvant endocrine therapy combined with chemotherapy
control group:Nil

Sponsors

Department of Urology, Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male, life expectancy = 5 years; 2. Primary patients with prostate cancer confirmed by biopsy before enrollment; 3. Patients with high risk (PSA>20ng/ml or clinical stage = T2c or GS score = 8) assessed by magnetic resonance imaging (MRI) and whole body bone scanning (ECT); 4. Patients without prostate related surgery, radiotherapy and endocrine therapy; 5. Willing to truthfully fill in the subject survey scale; 6. Willing to accept long-term follow-up; 7. The patient himself or his authorized lineal relatives have signed the informed consent form for clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients with bone metastasis (M1b) assessed by whole body bone scanning (ECT); 2. Complicated with other malignant tumors; 3. Those who have undergone pelvic surgery in the past, but not including transurethral endovascular surgery; 4. Have received pelvic radiotherapy in the past; 5. Have received systematic chemotherapy or endocrine therapy in the past; 6. Patients with severe systemic diseases (cardiovascular and cerebrovascular diseases, etc.) can not tolerate surgery or radiotherapy; 7. Patients participating in other clinical trials at the same time; 8. Poor compliance, unable to follow up as planned.

Design outcomes

Primary

MeasureTime frame
prostate specific antigen;free prostate specific antigen;

Secondary

MeasureTime frame
Testosterone;incontinence;

Countries

China

Contacts

Public ContactXu Gao

Shanghai Changhai Hospital

gaoxu.changhai@gmail.com+86 13501655091

Outcome results

None listed

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