Radiotherapy vs Observation for CRPC

Hormone Refractory Prostate Cancer Clinical Trial

Official title:

Salvage Radiotherapy vs Observation for Castration Resistant Prostate Cancer in Central China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01590498
• Other study ID #: PCA0608
• Secondary ID: NNSFC
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2012
• Last updated: May 3, 2012
• Start date: May 2012
• Est. completion date: March 2017

Study information

• Verified date: May 2012
• Source: Zhengzhou University
• Contact: Liu Bingqian, MD Ph.D
• Phone: 86-371-66862101
• Email: liubq76[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hormone Refractory Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
China	the first affiliated hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (7)

Lead Sponsor	Collaborator
Zhengzhou University	the cancer hospital of Zhengzhou University, The First Affiliated Hospital of Zhengzhou University, the second people's hospital of kaifeng, Xinyang Central Hospital, Zhengzhou People's Hospital, Zhoukou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No