CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer

July 19, 2021 updated by: Arica Hirsch, MD, Advocate Health Care

Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer

The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.

During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications.

The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Arica Hirsch, MD
  • Phone Number: 847-723-8030

Study Locations

    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Principal Investigator:
          • Arica Hirsch, MD
        • Contact:
          • Arica Hirsch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  • Patient must be ≥ 18 years of age.
  • Histologically proven prostate adenocarcinoma

    • Gleason score 2-10 (reviewed by reference lab)
    • Biopsy within one year of date of registration
    • Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition)
    • T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI; see section 4.5)
    • M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
  • PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment
  • Patients belonging in one of the following risk groups:

    • Intermediate: CS T2b-c and Gleason <6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7 and PSA ≤ 10 ng/ml, or Gleason <6 and PSA 11-20 ng/ml
    • High: CS T3-4, Gleason score >7and PSA<50
  • Prostate volume: ≤ 100 cc

    • Determined using: volume = π/6 x length x height x width
    • Measurement from MRI, CT or ultrasound prior to registration.
  • ECOG performance status 0-1
  • No prior prostatectomy or cryotherapy of the prostate
  • No prior radiotherapy to the prostate or lower pelvis
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  • No chemotherapy for a malignancy in the last 5 years.
  • No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermediate Risk

Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy

OR

Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)

Per current standard of care
Experimental: High Risk
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
Per current standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
Time Frame: 5 years
5 years
Measure local failure rates
Time Frame: 5 years
Measurement of local recurrence of prostate cancer
5 years
Measure distant failure rates
Time Frame: 5 years
Measurement of distant metastasis rate
5 years
Measure clinical disease-free survival rates
Time Frame: 5 years
5 years
Measure disease-specific survival rates
Time Frame: 5 years
5 years
Measure Overall Survival
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life (QOL) in generic and organ-specific domains
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arica Hirsch, MD, Advocate Lutheran General Hospital
  • Study Chair: Majid M Mohiuddin, MD, Advocate Lutheran General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2013

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

November 9, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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