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Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

Sponsor
VA Greater Los Angeles Healthcare System (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT04489745
Collaborator
(none)
72
Enrollment
1
Arm
97
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: SBRT
  • Drug: Androgen deprivation therapy (ADT)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Radiation: SBRT

Drug: Androgen deprivation therapy (ADT)

Outcome Measures

Primary Outcome Measures

  1. progression free survival [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • VA Greater Los Angeles Healthcare System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT04489745
Other Study ID Numbers:
  • VALosAngeles
First Posted:
Jul 28, 2020
Last Update Posted:
Jul 28, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms
Androgens

Study Results

No Results Posted as of Jul 28, 2020