This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
13-15 treatments with proton therapy given as a boost to standard of care photon therapy
University of Cincinnati
Cincinnati, Ohio, United States
Hematuria - Change from baseline
Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Urinary Incontinence - Change from baseline
Common Terminology Criteria for Adverse Events - Urinary Incontinence Scale - 1(least severe) - 3 (most severe)
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Dysuria - Change from baseline
Presence or Absence
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
International Prostate Symptom Score - Change from baseline
Records patient reported urinary symptoms - Scale 1-35 - 1-7 Mild symptoms, 8-19 Moderate symptoms, 20-35 Severe symptoms
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Rectal Bleeding - Change from baseline
Common Terminology Criteria for Adverse Events - Rectal Hemorrhage Scale - 1(least severe) - 5 (most severe)
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Erectile Dysfunction - Change from baseline
Common Terminology Criteria for Adverse Events - Erectile Dysfunction Scale - 1(least severe) - 3 (most severe)
Time frame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Progression Free Survival
Measured by time to cancer recurrence
Time frame: Monitored for 10 years after completion of radiation therapy
Overall Survival
Measured by time to cancer-related death
Time frame: Monitored for 10 years after completion of radiation therapy