Clinical trial NCT03564275: Proton Boost in Prostate Cancer
Official title: Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer of the Prostate
Keywords: Radiation Therapy
Proton Therapy
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Matched pair analysis. Each prospective patient will be matched with two historical patients based on the inclusion, exclusion and match criteria.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hematuria - Change from baseline
timeFrame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
measure: Urinary Incontinence - Change from baseline
timeFrame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
measure: Dysuria - Change from baseline
timeFrame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
measure: International Prostate Symptom Score - Change from baseline
timeFrame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
measure: Rectal Bleeding - Change from baseline
timeFrame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
measure: Erectile Dysfunction - Change from baseline
timeFrame: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Monitored for 10 years after completion of radiation therapy
measure: Overall Survival
timeFrame: Monitored for 10 years after completion of radiation therapy
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: William Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
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