NCT02830165

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

Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

Detailed description

PRIMARY OBJECTIVES: I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy. SECONDARY OBJECTIVES: I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite \[EPIC\] and International Prostate Symptom Score \[IPSS\] questionnaires). II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue. III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT. OUTLINE: Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy. After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.

Conditions

• Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7
• Stage II Prostate Adenocarcinoma AJCC v7
• Stage III Prostate Adenocarcinoma AJCC v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2016-06-15
• Primary completion: 2020-05-09
• Completion: 2022-05-27
• First posted: 2016-07-12
• Last updated: 2024-05-23
• Results posted: 2022-01-06

Locations

1 site across 1 country: United States