2 Years PSA Recurrence Rate Clinical Trial
Official title:
A Non-interventional Study of Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Chinese Prostate Cancer Patients.
| Verified date | January 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | Research Site | Beijing | Beijing |
| China | Research Site | Chen Du | Sichuan |
| China | Research Site | Guangzhou | Guangdong |
| China | Research Site | Hangzhou | Zhejiang |
| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Shanghai | |
| China | Research Site | Shenyang | Liaoning |
| China | Research Site | Tianjin | |
| China | Research Site | Wuhan | Hubei |
| China | Research Site | Xi'an | Shanxi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration). | Up to 2 years | No |