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A Randomized, Open-label, Phase II Trial of Neoadjuvant Docetaxel Combined with Goserelin for Very High-risk Locally Advanced Prostate Cancer Before Radical Prostatectomy

A Randomized, Open-label, Phase II Trial of Neoadjuvant Docetaxel Combined with Goserelin for Very High-risk Locally Advanced Prostate Cancer Before Radical Prostatectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-14005453
Enrollment
Unknown
Registered
2014-11-07
Start date
2014-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Prostate Cancer

Interventions

treatment group:Neoadjuvant Docetaxel+Goserelin+Radical Prostatectomy
control group:Radical Prostatectomy

Sponsors

Department of Urology, Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) pathology confirmed prostate adenocarcinoma; 2) very high risk locally advanced prostate cancer: TNM more than at least T3b; 3) no distant metastasis and lymphnode metastasis confirmed by imaging diagnosis; 4) To be aged 18-75 years old; 5) life expectancy longer than at least 10 years; 6) ECOG 0-1; 7) absolute white blood cell count more than at least 4.0*10^9/L, platelet count more than at least 100*10^9/L, Hemoglobin more than at least 90g/L, adequate hepatic and renal function; 8) has not been treated with hormone therapy or any kind of Cytotoxic drugs before; 9) all patients provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) have contraindications or suspected to be allergic to the involved drugs; 2) undergoing other anti-tumor treatments simultaneously; 3) those who has had other malignant disease, except for properly treated basal cell or squamous cell skin cancer, ervical carcinoma in situ, or patients with other cancers who had at least 5 years disease free survival; 4) immunodeficiency, AIDS; 5) severe disfunction of the heart, lung, liver and kidney; 6) severe infections or active infections; 7) known or suspected noncompliance.

Design outcomes

Primary

MeasureTime frame
2 year biochemical recurrence rate;

Secondary

MeasureTime frame
positive rate of margin;post operation PSA;

Countries

China

Contacts

Public ContactYe Dingwei
dwyeli@163.com+86 21 64175590-2807

Outcome results

None listed

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