Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

NCT ID: NCT04489745

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2025-01-31

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

Androgen deprivation therapy (ADT)

Intervention Type: DRUG

Interventions

SBRT

Intervention Type: RADIATION

Androgen deprivation therapy (ADT)

Intervention Type: DRUG

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

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

• 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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VA Greater Los Angeles Healthcare System

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

VALosAngeles

Identifier Type: -

Identifier Source: org_study_id