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Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) With a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT With a GNRH Agonist and TAK-700 For Men With High Risk Prostate Cancer

Primary Objective: To evaluate the difference in overall survival in men with clinically localized prostate cancer with unfavorable prognostic features between a) standard treatment (ADT + radiotherapy) and b) standard treatment with the addition of 24 months of TAK-700. Secondary Objectives: To characterize differences between the treatment groups with respect to incidence of unexpected grade greater than or equal to 3 adverse events and/or clinically significant decrement in patient reported quality of life among subjects treated with TAK-700. Additional Secondary Objectives Are to Compare the Treatment Groups With Respect To: Rates and cumulative incidence of biochemical control (freedom from PSA failure), local/regional progression, and distant metastases Rate and cumulative incidence of clinical failure, defined as: PSA greater than 25 ng/ml, documented local disease progression, regional or distant metastasis, or initiation of androgen deprivation therapy Prostate-cancer specific survival and other-cause mortality Change in severity of fatigue as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue short form Changes in patient reported quality of life as measured by Expanded Prostate Cancer Index Composite (EPIC) Assess quality adjusted survival using the EQ-5D Nadir and average serum testosterone at 12 and 24 months during treatment Changes in hemoglobin A1C, fasting glucose, and fasting insulin during 24 months of systemic treatment and during the first three years of follow-up Changes in fasting lipid levels during 24 months of treatment and during the first three years of follow-up Changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up Incidence of adverse events ascertained via CTCAE version 4. Rate of recovery of testosterone to greater than 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up Median time to recovery of testosterone to greater 230 ng/dL during the first five years of follow-up Cumulative incidence of relevant clinical survivorship endpoints including new diagnosis of type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, or osteoporotic fracture

Primary Objective: To evaluate the difference in overall survival in men with clinically localized prostate cancer with unfavorable prognostic features between a) standard treatment (ADT + radiotherapy) and b) standard treatment with the addition of 24 months of TAK-700. Secondary Objectives: To characterize differences between the treatment groups with respect to incidence of unexpected grade greater than or equal to 3 adverse events and/or clinically significant decrement in patient reported quality of life among subjects treated with TAK-700. Additional Secondary Objectives Are to Compare the Treatment Groups With Respect To: Rates and cumulative incidence of biochemical control (freedom from PSA failure), local/regional progression, and distant metastases Rate and cumulative incidence of clinical failure, defined as: PSA greater than 25 ng/ml, documented local disease progression, regional or distant metastasis, or initiation of androgen deprivation therapy Prostate-cancer specific survival and other-cause mortality Change in severity of fatigue as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue short form Changes in patient reported quality of life as measured by Expanded Prostate Cancer Index Composite (EPIC) Assess quality adjusted survival using the EQ-5D Nadir and average serum testosterone at 12 and 24 months during treatment Changes in hemoglobin A1C, fasting glucose, and fasting insulin during 24 months of systemic treatment and during the first three years of follow-up Changes in fasting lipid levels during 24 months of treatment and during the first three years of follow-up Changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up Incidence of adverse events ascertained via CTCAE version 4. Rate of recovery of testosterone to greater than 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up Median time to recovery of testosterone to greater 230 ng/dL during the first five years of follow-up Cumulative incidence of relevant clinical survivorship endpoints including new diagnosis of type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, or osteoporotic fracture