Proton Boost in Prostate Cancer
- Conditions
- Cancer of the Prostate
- Interventions
- Radiation: Proton Boost
- Registration Number
- NCT03564275
- Lead Sponsor
- University of Cincinnati
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 10
- ≥18 years of age
- Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) <10) -OR-
- Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20)
- Life expectancy >10 yrs
- Physically and mentally capable of signing the consent form of their own volition
- < 18 years of age
- Diagnosis of high risk prostate cancer (T3 or higher, Gleason >7 and/or PSA >20)
- Current or historical use of androgen deprivation therapy
- Nodal positivity
- Previous cancer excluding non-melanoma skin cancer
- History of prostatectomy
- History of brachytherapy for prostate cancer
- Life expectancy <10 yrs
- Physically or mentally incapable of signing the consent form of their own volition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prospective Treatment Group Proton Boost Proton Boost
- Primary Outcome Measures
Name Time Method Erectile Dysfunction - Change from baseline Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years Common Terminology Criteria for Adverse Events - Erectile Dysfunction Scale - 1(least severe) - 3 (most severe)
Hematuria - Change from baseline Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)
Urinary Incontinence - Change from baseline Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years Common Terminology Criteria for Adverse Events - Urinary Incontinence Scale - 1(least severe) - 3 (most severe)
Dysuria - Change from baseline Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years Presence or Absence
International Prostate Symptom Score - Change from baseline Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years Records patient reported urinary symptoms - Scale 1-35 - 1-7 Mild symptoms, 8-19 Moderate symptoms, 20-35 Severe symptoms
Rectal Bleeding - Change from baseline Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years Common Terminology Criteria for Adverse Events - Rectal Hemorrhage Scale - 1(least severe) - 5 (most severe)
- Secondary Outcome Measures
Name Time Method Progression Free Survival Monitored for 10 years after completion of radiation therapy Measured by time to cancer recurrence
Overall Survival Monitored for 10 years after completion of radiation therapy Measured by time to cancer-related death
Trial Locations
- Locations (1)
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States