Clinical trial NCT01226004: Multi-Institutional Registry for Prostate Cancer Radiosurgery
Official title: Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer Early Risk Treated by Radiosurgery
Prostate Cancer Intermediate Risk Treated by Radiosurgery
Keywords: radiosurgery
prostate
cancer
early
intermediate
CyberKnife
Lead sponsor: RPCR, Inc.
Sponsor class: OTHER
First posted: 2010-10-21
Enrollment: 3000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men over 18 who have early or intermediate risk prostate cancer and have chosen to undergo radiosurgical treatment

Brief summary: To address pertinent questions regarding the utilization of stereotactic Body Radiotherapy (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched the first registry for prostate cancer patients treated with SBRT. The registry is designed to track surrogate treatment endpoints including prostate specific antigen (PSA), international prostate symptom score (IPSS),sexual health in men (SHIM), and visual analogue scale (VAS) scores, in addition to physical and survival data. Utilizing an independent vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic registries, FRRA developed a data collection tool that staff members with a basic medical background can use to register and upload pertinent patient data, requiring no more than 20 to 30 minutes per patient. Participating patients will be monitored in follow-up for three years, with analysis and publication of the results semi-annually.

Detailed description: To address pertinent questions regarding the utilization of radiosurgery (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched the first registry for prostate cancer patients treated with SBRT.

The registry is designed to track surrogate treatment endpoints including PSA, IPSS, SHIM, QOL, Karnofsky Performance Status, VAS scores, urine and bowel health, in addition to physical and survival data. Utilizing an independent vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic registries.

FRRA developed a data collection tool that staff members with a basic medical background can use to register and upload pertinent patient data requiring no more than 20 to 30 minutes per patient. Participating patients will be monitored in follow-up for three years, with analysis and publication of the results semi-annually.

Eligibility criteria: Inclusion Criteria:

* pathological diagnosis of prostate cancer
* early or intermediate risk

Exclusion Criteria:

* high risk prostate cancer

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Treatment Outcomes
timeFrame: 5 years
measure: Treatment toxicity
timeFrame: 5 years
measure: Assess biochemical disease free survival using PSA
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: CyberKnife of Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama-USA Mitchell Cancer Institute
state: Alabama
city: Phoenix
country: United States
facility: Phoenix CyberKnife & Radiation Oncology Center
state: Arizona
city: Fresno
country: United States
facility: California Cancer Care
state: California
city: Newport Beach
country: United States
facility: Newport Diagnostic Center
state: California
city: San Diego
country: United States
facility: Scripps Clinic Radiation Therapy Centers
state: California
city: Tustin
country: United States
facility: Skyline Radiation Oncology
state: California
city: Colorado Springs
country: United States
facility: Penrose Cancer Center
state: Colorado
city: Lafayette
country: United States
facility: Colorado CyberKnife
state: Colorado
city: Lone Tree
country: United States
facility: Anova Cancer Care
state: Colorado
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Miami
country: United States
facility: CyberKnife Center of Miami
state: Florida
city: Naples
country: United States
facility: Naples Radiation Oncology
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute CyberKnife Center
state: Florida
city: Stuart
country: United States
facility: CyberKnife Center of South Florida in Stuart
state: Florida
city: Tampa
country: United States
facility: CyberKnife Centers of Tampa Bay
state: Florida
city: Marietta
country: United States
facility: WellStar Research Insititute
state: Georgia
city: Elmhurst
country: United States
facility: CyberKnife Center of Chicago
state: Illinois
city: Park Ridge
country: United States
facility: Illinois Cyberknife
state: Illinois
city: Lexington
country: United States
facility: Baptist Health
state: Kentucky
city: Billings
country: United States
facility: Saint Vincent Frontier Cancer Center
state: Montana
city: Great Falls
country: United States
facility: Benefis Sletten Cancer Institute
state: Montana
city: Missoula
country: United States
facility: Montana Cancer Institute Foundation
state: Montana
city: Lincoln
country: United States
facility: St. Elizabeth CyberKnife Center
state: Nebraska
city: Henderson
country: United States
facility: Las Vegas CyberKnife
state: Nevada
city: Reno
country: United States
facility: Reno CyberKnife
state: Nevada
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Johnson City
country: United States
facility: United Health Services
state: New York
city: Kettering
country: United States
facility: First Dayton Cancer Care
state: Ohio
city: Tulsa
country: United States
facility: St. John Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma CyberKnife
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America
state: Oklahoma
city: Havertown
country: United States
facility: Philadelphia CyberKnife
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Austin CyberKnife
state: Texas
city: Dallas
country: United States
facility: Premier Cancer Centers
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: St. Luke's Medical Center
state: Texas
city: San Antonio
country: United States
facility: The START Center for Cancer Care
state: Texas
city: Tyler
country: United States
facility: Cyberknife of Texas at East Texas Medical Center
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Spokane Valley
country: United States
facility: Spokane CyberKnife
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical Center
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
affiliation: South Florida Radiation Oncology, LLC.
name: Mark L. Perman, MD
role: PRINCIPAL_INVESTIGATOR
References: