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

Primary Purpose

Prostate Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberKnife
Androgen Deprivation Therapy (ADT)
Intensity Modulated radiation therapy (IMRT)
Sponsored by
Advocate Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Prostate neoplasm, Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Advocate Lutheran General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intermediate Risk

High Risk

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2013
Last Updated
July 19, 2021
Sponsor
Advocate Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT01985828
Brief Title
CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer
Official Title
Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2013 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Advocate Health Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Prostate neoplasm, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermediate Risk
Arm Type
Experimental
Arm Description
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)
Arm Title
High Risk
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
CyberKnife
Intervention Type
Other
Intervention Name(s)
Androgen Deprivation Therapy (ADT)
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated radiation therapy (IMRT)
Intervention Description
Per current standard of care
Primary Outcome Measure Information:
Title
Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Measure the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
Time Frame
5 years
Title
Measure local failure rates
Description
Measurement of local recurrence of prostate cancer
Time Frame
5 years
Title
Measure distant failure rates
Description
Measurement of distant metastasis rate
Time Frame
5 years
Title
Measure clinical disease-free survival rates
Time Frame
5 years
Title
Measure disease-specific survival rates
Time Frame
5 years
Title
Measure Overall Survival
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Quality of life (QOL) in generic and organ-specific domains
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arica Hirsch, MD
Phone
847-723-8030
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arica Hirsch, MD
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Majid M Mohiuddin, MD
Organizational Affiliation
Advocate Lutheran General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arica Hirsch, MD
First Name & Middle Initial & Last Name & Degree
Arica Hirsch, MD

12. IPD Sharing Statement

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

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