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


N/A
18 Years
N/A
Open (Enrolling)
Male
2 Years PSA Recurrence Rate

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome 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.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Karen Atkin

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

China: Food and Drug Administration

Study ID:

NIS-OCN-DUM-2009/2

NCT ID:

NCT01123434

Start Date:

April 2010

Completion Date:

March 2014

Related Keywords:

  • 2 Years PSA Recurrence Rate
  • prostate cancer
  • adjuvant
  • hormonal
  • Prostatic Neoplasms
  • Recurrence

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