Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT03541850
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-06
First Post:
2018-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-02032 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |