Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Prostate Cancer Patients.

Completed

• Conditions: 2 Years PSA Recurrence Rate

• Registration Number: NCT01123434
• Lead Sponsor: AstraZeneca

Brief Summary

The primary objective is to assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced Chinese prostate cancer patients.The secondary objective is to assess the quality of life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with immediate postoperative adjuvant hormonal treatment and get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-14
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Localised with one of any high recurrence risk factors(Gleason score≥8 or preoperative serum PSA≥20ng/ml), or locally advanced(T≥pT3、N0M0 and any T、N（+）M0 ) Chinese prostate cancer patients confirmed histologically through radical prostatectomy either with laparoscopy or laparotomy within 1 month after surgery. Before the patient recruitment, the investigator has decided to prescribe immediate postoperative adjuvant hormonal treatment to the patient according to the Chinese routine practice.
• Provision of written informed consent prior to any study specific procedures.

Exclusion Criteria

• Patients must not enter the study if any of the following exclusion criteria are fulfilled
• Have used neoadjuvant hormonal treatment prior to the surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced Chinese prostate cancer patients.	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).	Up to 2 years
To assess the quality of life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with immediate postoperative adjuvant hormonal treatment.	Up to 2 years

Trial Locations

Locations (1)

Research Site; 🇨🇳 Tianjin, China