Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer
Primary Purpose
Metastatic Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring Metastatic prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically-confirmed, adenocarcinoma of the prostate
- Clinical Stage T1b - T4, NX-0-1, M1
- Any Gleason score
- PSA<1000
- ECOG Performance Status 0-2
- No prior prostate radiation or other definitive therapy
Exclusion Criteria:
- Prior prostatectomy or cryotherapy of the prostate
- Prior 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
- Chemotherapy for a malignancy in the last 5 years
- History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
Sites / Locations
- Sharp Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STEREOTACTIC BODY RADIOTHERAPY
Arm Description
STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
Outcomes
Primary Outcome Measures
Radiation related toxicity
Radiation related toxicity as per history and physical, and 1 or several of Patient questionnaires:
SF-12 questionnaire AUA questionnaire EPIC-26 questionnaire SHIM questionnaire Utilization of Sexual Medications/Devices questionnaire
Secondary Outcome Measures
Feasibility
Feasibility in terms of accrual and practical treatment delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02206724
Brief Title
Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer
Official Title
PROSPECTIVE EVALUATION OF STEREOTACTIC BODY RADIOTHERAPY FOR METASTATIC PROSTATE CANCER
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to enroll patients
Study Start Date
July 16, 2014 (Actual)
Primary Completion Date
April 17, 2018 (Actual)
Study Completion Date
April 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sharp HealthCare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to test the safety and feasibility of prostate gland stereotactic body radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.
Detailed Description
The investigators and other investigators have previously documented the safety and efficacy of definitive intent stereotactic body radiotherapy (SBRT) in the treatment of localized prostate cancer.
In the metastatic setting for multiple malignancies, improved survival rates and disease outcomes have been shown with definitive treatment of the primary disease site. This concept of "cytoreductive" surgery or decreasing the primary tumor burden is now considered the standard of care for metastatic colon, ovarian, renal cell, and some breast carcinomas (plus post-surgery irradiation).
With new guidelines and declining rates of PSA screening, the incidence of newly diagnosed metastatic prostate cancer is expected to increase. A recent population-based study has concluded significant improvements in the definitive treatment of the local prostate cancer in the stage IV setting with either radical prostatectomy or conventional prostate radiation treatments/brachytherapy. To our knowledge, one prospective phase II trial is currently accruing patients to best systemic therapy or best systemic therapy (BST) plus definitive treatment with either radical prostatectomy or conventionally fractionated radiation therapy
The investigators hypothesize that the addition of primary disease SBRT to best systemic therapy for newly diagnosed metastatic prostate cancer would be associated with an acceptable safety profile, quality of life, disease progression, and overall survival. The addition of SBRT to best systemic therapy is also expected to be better-received for stage IV patients (with relatively limited prognosis), vs. fully fractionated radiation therapy, brachytherapy, or radical prostatectomy. The above endpoints would initially be tested in a prospective phase II multi-institutional trial and in comparison with historical controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
Metastatic prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STEREOTACTIC BODY RADIOTHERAPY
Arm Type
Experimental
Arm Description
STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
Intervention Type
Radiation
Intervention Name(s)
STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
Primary Outcome Measure Information:
Title
Radiation related toxicity
Description
Radiation related toxicity as per history and physical, and 1 or several of Patient questionnaires:
SF-12 questionnaire AUA questionnaire EPIC-26 questionnaire SHIM questionnaire Utilization of Sexual Medications/Devices questionnaire
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Feasibility
Description
Feasibility in terms of accrual and practical treatment delivery
Time Frame
3-4 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically-confirmed, adenocarcinoma of the prostate
Clinical Stage T1b - T4, NX-0-1, M1
Any Gleason score
PSA<1000
ECOG Performance Status 0-2
No prior prostate radiation or other definitive therapy
Exclusion Criteria:
Prior prostatectomy or cryotherapy of the prostate
Prior 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
Chemotherapy for a malignancy in the last 5 years
History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
Facility Information:
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer
We'll reach out to this number within 24 hrs