Clinical trial NCT01123434: Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Prostate Cancer Patients.
Official title: A Non-interventional Study of Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Chinese Prostate Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 2 Years PSA Recurrence Rate
Keywords: prostate cancer
adjuvant
hormonal
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients form urology surgery

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).


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.

Primary outcomes:
measure: 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.
timeFrame: Up to 2 years
Secondary outcomes:
measure: 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.
timeFrame: Up to 2 years
measure: Get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Chen Du
country: China
facility: Research Site
state: Sichuan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Shanghai
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Karen Atkin
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Yanjing Zhang
role: STUDY_CHAIR
affiliation: Peking University Shougang Hospital
name: Prof. Na
role: PRINCIPAL_INVESTIGATOR
affiliation: Tong Ji Hospital of Tongji Medical College of Huazhong University of Science and Technology
name: Prof. Ye
role: PRINCIPAL_INVESTIGATOR
References: