Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

VA Greater Los Angeles Healthcare System0 sites72 target enrollmentDecember 2016

ConditionsProstate Cancer

InterventionsSBRT Androgen deprivation therapy (ADT)

DrugsAndrogen deprivation therapy (ADT)

Overview

Phase: Phase 2
Intervention: SBRT
Conditions: Prostate Cancer
Sponsor: VA Greater Los Angeles Healthcare System
Enrollment: 72
Primary Endpoint: progression free survival
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients with localized high-risk or unfavorable intermediate risk prostate cancer

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

January 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

VA Greater Los Angeles Healthcare System

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
•High-risk or unfavorable intermediate-risk as defined below:
•High-risk localized prostate cancer, as defined by any one of the following factors:
•Pre-biopsy or any PSA ≥20 prior to enrollment, or Gleason score 8 or higher on any biopsy core, or cT3a or higher.
•Unfavorable intermediate risk localized prostate cancer, as defined as any of the following factors:
•Gleason score of 4+3 or higher on any biopsy core, or Gleason score 3+4 and \>50% biopsy cores positive, or The presence of any two of the following: PSA\>10, cT2b-c, Gleason score 3+4 in any core
•No pelvic nodal metastases (based on CT or MRI findings)
•No distant metastases, based upon:
•CT scan or MRI of the pelvis within 120 days prior to registration, Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
•KPS ≥ 70 (or ECOG 0-2)

Exclusion Criteria

•Patients with low-risk or favorable intermediate-risk prostate cancer do not meet inclusion criteria (these patients would be eligible for SBRT off-trial as a standard of care option)
•Patients with any evidence of distant metastases
•Hormonal therapy (LHRH agonist or oral anti-androgen) exceeding 7 months prior to registration
•Prior cryosurgery, HIFU or brachytherapy of the prostate
•Prior pelvic radiotherapy
•History of Crohn's Disease or Ulcerative Colitis

Arms & Interventions

SBRT and ADT

Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy

Intervention: SBRT

SBRT and ADT

Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy

Intervention: Androgen deprivation therapy (ADT)