The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Consists of: 1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE)) 2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy) 3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)
Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)
Mayo Clinic
Scottsdale, Arizona, United States
RECRUITINGNorthwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
RECRUITINGOklahoma Proton Center
Oklahoma City, Oklahoma, United States
RECRUITINGHampton University Proton Therapy Institute
Hampton, Virginia, United States
RECRUITINGMorbidity Outcomes
To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression. Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression
Time frame: after the initial 100 patients have had a median follow up of at least three years and then every year.
Frequency and severity of grade 2 or higher GU and GI toxicity
Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria
Time frame: At 6 months
Frequency and severity of GI and GU toxicity
Time frame: At 3 years
Incidence of quality of life issues
Time frame: At completion of radiation therapy
Incidence of Freedom from biochemical failure (FFBF)
Time frame: At 5 years
Incidence of clinical failure: local and/or distant
Time frame: At 5 years
Incidence of salvage Androgen Suppression use (SAD)
Time frame: At 5 years
Incidence of progression free survival: using clinical, biochemical and SAD as events
Time frame: At 5 years
Incidence of overall survival
Time frame: At 5 years
Incidence of disease-specific survival
Time frame: At 5 years
Correlate pathologic and radiologic findings with outcomes
Time frame: At 5 years
Correlate PSA and free PSA levels with outcomes
Time frame: At 5 years
Correlate testosterone levels and variation with proton therapy and outcomes
Time frame: At 5 years
Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity
Time frame: At 3 years
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