Radiotherapy vs Observation for CRPC

This study is currently recruiting participants.
Verified May 2012 by Zhengzhou University
Sponsor:
Collaborators:
The First Affiliated Hospital of Zhengzhou University
the cancer hospital of Zhengzhou University
People's hospital of Zhengzhou University
Zhengzhou central hospital affiliated to Zhengzhou University
Zhengzhou people's hospial
Xinyang central hospital
Zhoukou central hospital
the second people's hospital of kaifeng
Information provided by (Responsible Party):
Liu Bingqian, Zhengzhou University
ClinicalTrials.gov Identifier:
NCT01590498
First received: April 27, 2012
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer.


Condition
Hormone Refractory Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Salvage Radiotherapy vs Observation for Castration Resistant Prostate Cancer in Central China

Resource links provided by NLM:


Further study details as provided by Zhengzhou University:

Primary Outcome Measures:
  • overall survival [ Time Frame: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or date of death from any cause, whichever came first, assessed up to 3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prostate cancer specific mortality [ Time Frame: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or death from prostate cancer or treatment complications, whichever came first, assessed up to 3 years. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

the biopsy specimens of prostate tissue


Estimated Enrollment: 2000
Study Start Date: May 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Salvage radiotherapy
local radiation to the prostate and metastasis following biochemical or clinical recurrence
observation
did not receive salvage following biochemical or clinical recurrence

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

inpatients with CRPC in 9 hospitals

Criteria

Inclusion Criteria:

  1. Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy
  2. Patients were receiving primary androgen-ablation therapy as maintenance therapy. At least four weeks had to have elapsed between the withdrawal of antiandrogens (six weeks in the case of bicalutamide) and enroll ment, so as to avoid the possibility of confounding as a result of the response to antiandrogen withdrawal.
  3. Another requirement was disease progression, as indicated by increasing serum levels of PSA on three consecutive measurements obtained at least one week apart or findings on physical examination or imaging studies.
  4. Normal cardiac function was required.

Exclusion Criteria:

  1. patients had a Karnofsky performance-status score of at most 60 percent
  2. prior treatment with cytotoxic agents or radioisotopes
  3. with history of another cancer within the preceding five years, brain or leptomeningeal metastases, symptomatic peripheral neuropathy of grade 2 or higher, and other serious medical condition.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590498

Contacts
Contact: Liu Bingqian, MD Ph.D 86-371-66862101 liubq76@yahoo.com.cn

Locations
China, Henan
the first affiliated hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Zhengzhou University
The First Affiliated Hospital of Zhengzhou University
the cancer hospital of Zhengzhou University
People's hospital of Zhengzhou University
Zhengzhou central hospital affiliated to Zhengzhou University
Zhengzhou people's hospial
Xinyang central hospital
Zhoukou central hospital
the second people's hospital of kaifeng
Investigators
Principal Investigator: Liu Bingqian, MD Ph.D The First Affiliated Hospital of Zhengzhou University
  More Information

No publications provided

Responsible Party: Liu Bingqian, Principal Investigator, Zhengzhou University
ClinicalTrials.gov Identifier: NCT01590498     History of Changes
Other Study ID Numbers: PCA0608, NNSFC
Study First Received: April 27, 2012
Last Updated: May 3, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Zhengzhou University:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Prostatic Diseases

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014