Stereotactic Body Radiotherapy for Prostate Cancer
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer
1 other identifier
interventional
84
1 country
1
Brief Summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Jun 2011
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 12, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedResults Posted
Study results publicly available
September 23, 2020
CompletedSeptember 23, 2020
September 1, 2020
7.8 years
May 10, 2011
July 29, 2020
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemical Control Rate
Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.
one year
Secondary Outcomes (1)
Late Toxicity Rate
one year
Study Arms (1)
Stereotactic Body Radiotherapy
OTHERPatients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Interventions
Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Eligibility Criteria
You may qualify if:
- Patient age \>= 18 years
- Zubrod performance status of 0-3
- T1-3 N0 M0 adenocarcinoma of the prostate
- Prostate volume ≤ 100 cc
- Signed study-specific consent form
You may not qualify if:
- Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
- Prostate volume \> 100 cc
- Nodal involvement
- Metastatic disease
- Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
- History of scleroderma
- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mercy Researchlead
Study Sites (1)
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jaymeson Stroud, MD
- Organization
- Mercy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiation Oncologist
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 12, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
September 23, 2020
Results First Posted
September 23, 2020
Record last verified: 2020-09