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About
A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary objective is determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.
Full description
Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy with Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) Primary Objective: To determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.
Design: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment.
Enrollment
Sex
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Volunteers
Inclusion criteria
Histological confirmation of adenocarcinoma of the prostate.
Age > 18 years.
Localized high-risk prostate cancer, defined as:
PSA > 20 ng/mL.
Karnofsky index ≥ 70%
Good bone marrow reserve, with white blood cell count > 3000/mm3, hemoglobin >9.5 g/dL and platelets > 150,000/mm3.
Absence of hepatic abnormality, with bilirubin values < 1.5 mg/dL and with SGOT/SGPT values up to 2 times the upper limit of normality for each site.
Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
Having given informed consent in writing.
Exclusion criteria
Primary purpose
Allocation
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Masking
134 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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