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Radiotherapy vs Observation for CRPC

Sponsor
Zhengzhou University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01590498
Collaborator
The First Affiliated Hospital of Zhengzhou University (Other), the cancer hospital of Zhengzhou University (Other), People's Hospital of Zhengzhou University (Other), Xinyang Central Hospital (Other), Zhoukou Central Hospital (Other), the second people's hospital of kaifeng (Other)
2,000
Enrollment
1
Location
58
Duration (Months)
34.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Salvage Radiotherapy vs Observation for Castration Resistant Prostate Cancer in Central China
    Study Start Date :
    May 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2016
    Anticipated Study Completion Date :
    Mar 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Salvage radiotherapy

    local radiation to the prostate and metastasis following biochemical or clinical recurrence
    observation

    did not receive salvage following biochemical or clinical recurrence

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [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.]

    Secondary Outcome Measures

    1. prostate cancer specific mortality [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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 the first affiliated hospital of Zhengzhou University 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
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liu Bingqian, Principal Investigator, Zhengzhou University
    ClinicalTrials.gov Identifier:
    NCT01590498
    Other Study ID Numbers:
    • PCA0608
    • NNSFC
    First Posted:
    May 3, 2012
    Last Update Posted:
    May 4, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Liu Bingqian, Principal Investigator, Zhengzhou University
    Adenocarcinoma
    Prostatic Neoplasms
    Carcinoma
    Prostatic Diseases
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of May 4, 2012