NCT03541850

Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

Detailed description

PRIMARY OBJECTIVES: I. To determine the efficacy of postoperative stereotactic body radiation therapy (SBRT) at a dose of 34 grays (Gy) in five fractions, as compared with historical control efficacy rates in patients who received conventionally fractionated postoperative radiotherapy. II. To determine the toxicity of postoperative SBRT at a dose of 34 Gy in five fractions, both via physician-scored and patient-reported metrics. SECONDARY OBJECTIVES: I. To determine the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with magnetic resonance imaging (MRI)-guided radiotherapy. II. To gather biomarkers that may elucidate predictors of increased efficacy or increased toxicity. TERTIARY OBJECTIVES: I. To compare toxicity profiles (both physician-scored and patient-reported) between patients treated utilizing a linear accelerator versus a tri-60Co teletherapy platform. OUTLINE: Patients undergo SBRT every other day (QOD) for 14 days. Patients may also receive androgen deprivation therapy (ADT) comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician. After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Conditions

• PSA Level Greater Than 0.03
• PSA Progression
• Stage I Prostate Adenocarcinoma AJCC (American Joint Committee on Cancer ) v7
• Stage II Prostate Adenocarcinoma AJCC v7
• Stage III Prostate Adenocarcinoma AJCC v7

Interventions

Type	Name	Description
DRUG	Antiandrogen Therapy	Receive luteinizing hormone-releasing hormone agonist or gonadotropin-releasing hormone antagonist, and oral anti-androgen
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2019-01-29
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2018-05-31
• Last updated: 2025-11-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study