Clinical Trials

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