Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

NCT04489745 | Unknown Phase 2

• 1 other identifier: VALosAngeles
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• progression free survival

  progression is defined by biochemical (phoenix definition), clinical, or radiographic

  5 years

Study Arms (1)

SBRT and ADT

EXPERIMENTAL

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

Radiation: SBRT; Drug: Androgen deprivation therapy (ADT)

Interventions

SBRT RADIATION

SBRT and ADT

Androgen deprivation therapy (ADT) DRUG

SBRT and ADT

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: December 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2025
• Last Updated: July 28, 2020

Record last verified: 2020-07