Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer. The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started Aug 2009
Longer than P75 for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 28, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 18, 2015
November 1, 2015
7 years
August 28, 2009
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PSA decline measured through laboratory testing.
One month following radiosurgery through 5 year follow up
Secondary Outcomes (1)
Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.
One month following radiosurgery through 5 years follow up.
Study Arms (1)
Stereotactic Radiosurgery using NovalisTx
EXPERIMENTALSingle arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.
Interventions
Five treatments given every other day.
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the prostate
- Gleason score ≤ 6 and low volume Gleason 7 (3+4)
- PSA \< 10
- Clinical Stage of T2a or less
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Prior radiation treatment for prostate cancer
- Gleason score \> 7
- PSA \> 10
- Clinical Stage of T2b or greater
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Diego Radiosurgery at Palomar Medical Center
Escondido, California, 92025, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P. Brian Volpp, MD, MPH
San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2009
First Posted
September 1, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2016
Study Completion
December 1, 2016
Last Updated
November 18, 2015
Record last verified: 2015-11