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

Study Overview
=================
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).

Official Title
-----------------
A Non-interventional Study of Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Chinese Prostate Cancer Patients.

Conditions
-----------------
2 Years PSA Recurrence Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Localised with one of any high recurrence risk factors, or locally advanced 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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration). |  | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, adjuvant, hormonal