NCT02653248

SBRT for Organ Confined Prostate Cancer

Phase I Study of Stereotactic Body Radiation Therapy (SBRT) for Organ Confined Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stereotactic Body Radiation Therapy (SBRT) is a method of delivering radiation which can target the tumor more precisely and cause less damage to normal tissue. This is a Phase I research study looking at the safety of the dose of SBRT in organ confined prostate cancer.

Detailed description

Radiation options for treating early stage prostate cancer can include external radiation therapy, which is radiation given outside the body, or prostate seed implant, which is placing radioactive seeds directly into the prostate. For external beam radiation therapy, treatment can last up to 9 weeks. Treatment is given daily, Monday through Friday. This may not be the most convenient option for some patients. One way to potentially overcome this challenge is to deliver a more intense dose of radiation treatment to the tumor over a shorter amount of time. Stereotactic Body Radiation Therapy (SBRT) is a technique that treats the prostate with fewer treatments and can decrease the effect of radiation to the surrounding tissues. This study is a Phase I research study, which means that it will look at the safety of the dose of the SBRT. While SBRT itself is a standard of care method to administer radiation therapy, there has not been a specific dose outlined in the past. The aim of this study is to determine the dose that will treat the prostate cancer but cause the least amount of side effects.

Conditions

• Adenocarcinoma
• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy	Patients will receive 5 fractions of SBRT radiation, treated every other day. No more than three fractions per week. Total dose will depend on cohort. Cohort 1: 40Gy, Cohort 2: 45 Gy, Cohort 3: 50 Gy.

Timeline

• Start date: 2010-08-01
• Primary completion: 2018-06-01
• Completion: 2021-12-01
• First posted: 2016-01-12
• Last updated: 2022-02-09

Locations

1 site across 1 country: United States