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


N/A
N/A
N/A
Open (Enrolling)
Male
Hormone Refractory Prostate Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

overall survival

Outcome 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.

Safety Issue:

No

Principal Investigator

Liu Bingqian, MD Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First Affiliated Hospital of Zhengzhou University

Authority:

China: National Natural Science Foundation

Study ID:

PCA0608

NCT ID:

NCT01590498

Start Date:

May 2012

Completion Date:

March 2017

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Adenocarcinoma
  • Prostatic Neoplasms
  • Carcinoma
  • Prostatic Diseases
  • Prostatic Neoplasms

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