Proton Boost in Prostate Cancer

University of Cincinnati

Status: Active, not recruiting

Conditions: Cancer of the Prostate

Treatments: Radiation: Proton Boost

Study type: Interventional

Funder types: Other

Identifiers

NCT03564275

2017-1091

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Prospective Treatment Group

Experimental group

Description:

Proton Boost

Treatment:

Radiation: Proton Boost

Retrospective Comparison Group

No Intervention group

Description:

Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.