Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer of the Prostate
- Sponsor
- University of Cincinnati
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Erectile Dysfunction - Change from baseline
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
William Barrett
Director, University of Cincinnati Cancer Institute Medical Director, Charles M. Barrett Cancer Center Professor and Chairman, Radiation Oncology University of Cincinnati
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •≥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
Exclusion Criteria
- •\< 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
Outcomes
Primary Outcomes
Erectile Dysfunction - Change from baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Progression Free Survival(Monitored for 10 years after completion of radiation therapy)
- Overall Survival(Monitored for 10 years after completion of radiation therapy)