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Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Primary Purpose

Prostate Cancer, Prostatic Cancer, Prostate Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberKnife Stereotactic Radiosurgery
Sponsored by
Swedish Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Radiation, Stereotactic Radiosurgery, Radiotherapy, Prostate Tumor, Prostate Surgery, CyberKnife

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven prostate adenocarcinoma
  • Clinical stage T1a-T3, N0-Nx, M0-Mx
  • Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 & <20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20
  • Karnofsky performance status 70-100
  • Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
  • Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment
  • High risk group: three hormone therapy regimens are allowed
  • 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed

Exclusion Criteria:

  • Prior prostatectomy or cryotherapy of the prostate
  • Prior high-dose radiotherapy to the prostate or lower pelvis
  • Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion

Sites / Locations

  • Swedish Medical Center Radiosurgery CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CyberKnife Stereotactic Radiosurgery

Arm Description

This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.

Outcomes

Primary Outcome Measures

Quality of life outcomes (low- and intermediate-risk prostate cancer groups)
In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial.
Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)
In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.

Secondary Outcome Measures

Rates of toxicities related to treatment
After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment.
Disease free survival
Measure disease free survival after five years following cyberknife stereotactic radiosurgery.
Overall survival
Measure overall survival after five years following cyberknife stereotactic radiosurgery.

Full Information

First Posted
December 4, 2014
Last Updated
July 11, 2019
Sponsor
Swedish Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02334579
Brief Title
Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer
Official Title
Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate
Keywords
Radiation, Stereotactic Radiosurgery, Radiotherapy, Prostate Tumor, Prostate Surgery, CyberKnife

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CyberKnife Stereotactic Radiosurgery
Arm Type
Experimental
Arm Description
This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Stereotactic Radiosurgery
Intervention Description
Five treatments given over about one week.
Primary Outcome Measure Information:
Title
Quality of life outcomes (low- and intermediate-risk prostate cancer groups)
Description
In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial.
Time Frame
8 years
Title
Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)
Description
In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.
Time Frame
8 years
Secondary Outcome Measure Information:
Title
Rates of toxicities related to treatment
Description
After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment.
Time Frame
5 years
Title
Disease free survival
Description
Measure disease free survival after five years following cyberknife stereotactic radiosurgery.
Time Frame
5 years
Title
Overall survival
Description
Measure overall survival after five years following cyberknife stereotactic radiosurgery.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
Measure quality of life after five years following cyberknife stereotactic radiosurgery.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven prostate adenocarcinoma Clinical stage T1a-T3, N0-Nx, M0-Mx Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 & <20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20 Karnofsky performance status 70-100 Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment High risk group: three hormone therapy regimens are allowed 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed Exclusion Criteria: Prior prostatectomy or cryotherapy of the prostate Prior high-dose radiotherapy to the prostate or lower pelvis Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Monahan
Phone
(206) 320-7129
Email
mary.monahan@swedish.org
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Meier, MD
Phone
(206) 320-7130
Email
robert.meier@swedish.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Meier, MD
Organizational Affiliation
Swedish Medical Center Radiosurgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Medical Center Radiosurgery Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Monahan
Phone
206-320-7029
Email
mary.monahan@swedish.org
First Name & Middle Initial & Last Name & Degree
Robert Meier, MD
Phone
(206) 320-7130
Email
robert.meier@swedish.org
First Name & Middle Initial & Last Name & Degree
Robert Meier, MD

12. IPD Sharing Statement

Links:
URL
http://www.swedish.org/services/radiosurgery-center
Description
Swedish Medical Center Radiosurgery Center

Learn more about this trial

Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

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