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Radiotherapy vs Observation for CRPC

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01590498
Enrollment
2000
Registered
2012-05-03
Start date
2012-05-31
Completion date
2017-03-31
Last updated
2012-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone Refractory Prostate Cancer

Keywords

Adenocarcinoma, Prostatic Neoplasms, Carcinoma, Prostatic Diseases

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.

Interventions

None listed

Sponsors

The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
the cancer hospital of Zhengzhou University
CollaboratorUNKNOWN
People's Hospital of Zhengzhou University
CollaboratorOTHER
Xinyang Central Hospital
CollaboratorOTHER
Zhoukou Central Hospital
CollaboratorOTHER
the second people's hospital of kaifeng
CollaboratorUNKNOWN
Zhengzhou University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
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.

Design outcomes

Primary

MeasureTime frame
overall survivalFrom 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

MeasureTime frame
prostate cancer specific mortalityFrom 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.

Countries

China

Contacts

Primary ContactLiu Bingqian, MD Ph.D
liubq76@yahoo.com.cn86-371-66862101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026