|Principal Name||Harvey Zimbler, MD|
|Contact Name||Gloria Gero|
|Alternate Phone||(413) 443-6000|
|Title||RTOG 0815- A Phase III Prospective Randomized Trial of Dose-escalated Radiotherapy With or Without Short-Term and Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer"|
to demonstrate an oveall 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 objective :
- Determine whether the addition of ADT to dose-escalated RT imporves clinical failures (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the "nadir + 2" (Phoenix) definition, freedom from failure (the first occurrence of clinical failure or biochemical falure 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
- Compare acute and late treatment adverse events for patients receviing vs. not receiving ADT and correlate this
with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbity Evaluation 27
- Determien whether HRQOL as measured by the EPIC significantly worsens as a funciton of treatment assignment.
- Demonstrate the addition of ADT to dose-escalated RT is associated with the higher fatigue severity than dose-
escalated RT alone by the Patient-Reporeted Outscome Measurement Inforatino System (PROMIS) fatigue domain
- Pathologically (histologically)proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 6 months prior to registration as determined by having onr or more of the following intermediate-risk features: Gleason Score 7; PSA>10 but <20; Clnical Stage T2b-T2c.
- Patients preiously diagnosed with low risk (Gleaseon score <6, clinical stage |
|Current Trial Type||Treatment|