Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04489745
• Other study ID #: VALosAngeles
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: January 2025

Study information

• Verified date: July 2020
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: January 2025
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• SBRT

Drug:
• Androgen deprivation therapy (ADT)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	progression is defined by biochemical (phoenix definition), clinical, or radiographic	5 years