The purpose of the study is to determine whether radiotherapy improves cancer control and
overall survival among patients with Castration resistant prostate cancer.
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Full eligibility criteria for NCT01590498
Ages eligible for Study
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01590498
the first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
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Tris trial is registered with FDA with number: NCT01590498. The sponsor of the trial is Zhengzhou University and it is looking for 2000 volunteers for the current phase.
Official trial title: Salvage Radiotherapy vs Observation for Castration Resistant Prostate Cancer in Central China
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