Radiotherapy vs Observation for CRPC

NCT01590498 | Unknown

• 2 other identifiers: PCA0608NNSFC
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone Refractory Prostate Cancer

Keywords

Adenocarcinoma; Prostatic Neoplasms; Carcinoma; Prostatic Diseases

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Study Arms (2)

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 Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

inpatients with CRPC in 9 hospitals

You may qualify if:

• Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy
• 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.
• 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.
• Normal cardiac function was required.

You may not qualify if:

• patients had a Karnofsky performance-status score of at most 60 percent
• prior treatment with cytotoxic agents or radioisotopes
• 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.

Sponsors & Collaborators

• Zhengzhou University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• the cancer hospital of Zhengzhou University: collaborator
• People's Hospital of Zhengzhou University: collaborator
• Xinyang Central Hospital: collaborator
• Zhoukou Central Hospital: collaborator
• the second people's hospital of kaifeng: collaborator

Study Sites (1)

the first affiliated hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

the biopsy specimens of prostate tissue

MeSH Terms

Conditions

Adenocarcinoma; Prostatic Neoplasms; Carcinoma; Prostatic Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Liu Bingqian, MD Ph.D

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Bingqian, MD Ph.D

CONTACT

86-371-66862101; liubq76@yahoo.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 3, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 4, 2012

Record last verified: 2012-05

Locations

CN (1)