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A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

Primary To demonstrate an overall survival (OS) advantage for the addition of short-term (6 months) ADT to dose-escalated RT for patients with intermediate-risk prostate cancer. The events for OS will be defined as death due to any cause. Secondary (12/10/10) Determine whether the addition of ADT to dose-escalated RT improves clinical failures (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the nadir + 2 (Phoenix) definition 60, freedom from failure (the first occurrence of clinical failure or biochemical failure by the Phoenix definition), rate of salvage ADT, and prostate cancer-specific mortality without resulting in increased non-prostate cancer-specific mortality over dose-escalated RT alone Estimate the magnitude of benefit of ADT with respect to OS for patients treated with different RT modalities (i.e., EBRT alone vs. LDR brachytherapy boost vs. HDR brachytherapy boost) Compare acute and late treatment adverse events for patients receiving vs. not receiving ADT and correlate this with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 (ACE-27) assessment.18-20 Determine whether HRQOL as measured by the EPIC significantly worsens as a function of treatment assignment (i.e., ADT + RT compared to RT alone) Demonstrate that the addition of ADT to dose-escalated RT is associated with higher fatigue severity than dose-escalated RT alone by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue domain Demonstrate an incremental gain in OS with more aggressive therapy that outweighs the detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), reported as QALY. Determine whether the PROMIS score change is correlated with plasma cytokine change Collect paraffin-embedded tissue blocks, plasma, and whole blood for future translational research analyses

Primary To demonstrate an overall survival (OS) advantage for the addition of short-term (6 months) ADT to dose-escalated RT for patients with intermediate-risk prostate cancer. The events for OS will be defined as death due to any cause. Secondary (12/10/10) Determine whether the addition of ADT to dose-escalated RT improves clinical failures (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the nadir + 2 (Phoenix) definition 60, freedom from failure (the first occurrence of clinical failure or biochemical failure by the Phoenix definition), rate of salvage ADT, and prostate cancer-specific mortality without resulting in increased non-prostate cancer-specific mortality over dose-escalated RT alone Estimate the magnitude of benefit of ADT with respect to OS for patients treated with different RT modalities (i.e., EBRT alone vs. LDR brachytherapy boost vs. HDR brachytherapy boost) Compare acute and late treatment adverse events for patients receiving vs. not receiving ADT and correlate this with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 (ACE-27) assessment.18-20 Determine whether HRQOL as measured by the EPIC significantly worsens as a function of treatment assignment (i.e., ADT + RT compared to RT alone) Demonstrate that the addition of ADT to dose-escalated RT is associated with higher fatigue severity than dose-escalated RT alone by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue domain Demonstrate an incremental gain in OS with more aggressive therapy that outweighs the detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), reported as QALY. Determine whether the PROMIS score change is correlated with plasma cytokine change Collect paraffin-embedded tissue blocks, plasma, and whole blood for future translational research analyses