NCT02296229

Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer

Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials. II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer. III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer. OUTLINE: Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician. After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.

Conditions

• Adenocarcinoma of the Prostate
• Stage III Prostate Cancer

Interventions

Type	Name	Description
RADIATION	stereotactic body radiation therapy	Undergo SBRT
OTHER	quality-of-life assessment	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies
DRUG	androgen deprivation therapy	up to 9 months at the discretion of the treating physician

Timeline

• Start date: 2014-01-27
• Primary completion: 2026-01-27
• Completion: 2027-01-27
• First posted: 2014-11-20
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States