Cancer of the Prostate
Conditions
Keywords
Radiation Therapy, Proton Therapy
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.
Interventions
RADIATIONProton Boost
13-15 treatments with proton therapy given as a boost to standard of care photon therapy
Sponsors
University of Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Matched pair analysis. Each prospective patient will be matched with two historical patients based on the inclusion, exclusion and match criteria.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Monitored for 10 years after completion of radiation therapy | Measured by time to cancer-related death |
| Progression Free Survival | Monitored for 10 years after completion of radiation therapy | Measured by time to cancer recurrence |
Countries
United States
Outcome results
None listed