Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: SBRT; Drug: Androgen deprivation therapy (ADT)

• Registration Number: NCT04489745
• Lead Sponsor: VA Greater Los Angeles Healthcare System

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Status Verified: 2020-07
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Study First Posted: 2020-07-28
• Last Update Posted: 2020-07-28
• Primary Completion: 2022-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 72

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

• Age ≥ 18
• KPS ≥ 70 (or ECOG 0-2)
• Ability to understand, and willingness to sign, the written informed consent

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT and ADT	SBRT	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
SBRT and ADT	Androgen deprivation therapy (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

Primary Outcome Measures

Name	Time	Method
progression free survival	5 years	progression is defined by biochemical (phoenix definition), clinical, or radiographic