Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01123434
First received: May 10, 2010
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition
2 Years PSA Recurrence Rate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-interventional Study of Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Chinese Prostate Cancer Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration). [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients form urology surgery

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123434

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shanxi
Research Site
Xi'an, Shanxi, China
China, Sichuan
Research Site
Chen Du, Sichuan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
China
Research Site
Shanghai, China
Research Site
Tianjin, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Karen Atkin AstraZeneca
Study Chair: Yanjing Zhang AstraZeneca
Principal Investigator: Prof. Na Peking University Shougang hospital
Principal Investigator: Prof. Ye Tong Ji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01123434     History of Changes
Other Study ID Numbers: NIS-OCN-DUM-2009/2
Study First Received: May 10, 2010
Last Updated: April 9, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
prostate cancer
adjuvant
hormonal

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Disease Attributes
Pathologic Processes
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013