Berkshire Health Systems - The region's leading provider of comprehensive health care services
Berkshire Medical Center Northern Berkshire Campus of BMC Fairview Hospital Berkshire VNA & Hospice Long Term Care
About Berkshire Health Systems BHS Locations Our Services Employment Opportunities Medical Education Physician Finder
Related Links

Principal Name   Harvey Zimbler, MD
Contact Name   Gloria Gero
Phone   (413) 496-8205
Alternate Phone   (413) 443-6000
Fax   (413) 443-2203
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"
Description   Primary objective;
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
assessment
- 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
Treatment   Oncology
Inclusion/Notes   ELIGIBILITY- - 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 18 - Baseline serum PSA performed with an FDA-approved assay within 60 days prior to registration - For patients undergoing brachytherapy only: CBC/differential obtained within 60 days prior to registration, with adequate bone marrow function defined as follows: ANC > 1800 cell/mm3 Platelets >100,000 cell/mm3 Hemoglovin >8.0 g/dl - Patient must be able to provide study-specific informed consent prior to study entry. INELIGIBILITY: - Patients with GLeason score >8; PSA>20 OR Clnical Stage > T3 are ineligible for this trial - Patient with all three intermediate risk factors who also have >50% of the nuber of their biopsy cores positive for cancer - Prior invasive malignancy or hematological mealignancy unless disease free for a minimun of 5 years - Prior radical surgery (prostatectomy), high-intensity focused ultrasound or cryosurgery for prostate cancer. - Prior hormonal therapy, such as LHRH agonists, estrogens,l or bilateral orchiectomy - Use of finasteride within 30 days prior to registration - Use of dutasteride within 90 days prior to registration - Prior RT, including bracytherapy, to the region of the study cancer that would result in overlap of RT fiels. - Severe active co-morbibity - Men who are sexually active with a woman ofchild-bearing portential and not willing/able to use medically acceptable forms of contraception during protocol treatment and during the first 3 months after cessation of protocol treatment.
Status   accruing
Current Trial Type   Treatment


font size Decrease (-) Default Increase (+)
Print
Email