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Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial


N/A
18 Years
90 Years
Open (Enrolling)
Male
Prostate Cancer Early Risk Treated by Radiosurgery, Prostate Cancer Intermediate Risk Treated by Radiosurgery

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Trial Information

Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial


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.


Inclusion Criteria:



- pathological diagnosis of prostate cancer

- early or intermediate risk

Exclusion Criteria:

- high risk prostate cancer

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Overall survival

Outcome Time Frame:

three years

Safety Issue:

No

Principal Investigator

Mark L. Perman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

South Florida Radiation Oncology, LLC.

Authority:

United States: Institutional Review Board

Study ID:

FRRA01

NCT ID:

NCT01226004

Start Date:

July 2010

Completion Date:

July 2015

Related Keywords:

  • Prostate Cancer Early Risk Treated by Radiosurgery
  • Prostate Cancer Intermediate Risk Treated by Radiosurgery
  • radiosurgery
  • prostate
  • cancer
  • early
  • intermediate
  • CyberKnife
  • Prostatic Neoplasms

Name

Location

Penrose Cancer CenterColorado Springs, Colorado  80933
Georgetown UniversityWashington, District of Columbia  20007-2197
St. Luke's Episcopal HospitalHouston, Texas  77030
North Broward Medical CenterDearfield Beach, Florida  33064-3596
Denver CyberKnifeLone Tree, Colorado  80124
Pasadena Cyberknife CenterPasadena, California  91105
Colorado CyberknifeLafayette, Colorado  80026
Cancer Care Centers of BrevardRockledge, Florida  32955
Newport Diagnostic CenterNewport Beach, California  92660
CyberKnife of Southern California at VistaVista, California  92081
Rocky Mountain CyberKnifeBoulder, Colorado  80304
JFK HospitalAtlantis, Florida  33462
CyberKnife Centers of Tampa Bay at BrandonBrandon, Florida  33511
Coastal CyberKnifeFt. Pierce, Florida  34982
CyberKnife Institute at Mercy HospitalMiami, Florida  33133
CyberKnife Center of MiamiMiami, Florida  33156
University of Miami/Sylvester Cancer CenterMiami, Florida  33136
CyberKnife Center of Palm BeachPalm Beach Gardens, Florida  33410
Memorial Cancer Institute CyberKnife CenterPembroke Pines, Florida  33028
CyberKnife Center of South Florida in StuartStuart, Florida  33996
CyberKnife Centers of Tampa BayTampa, Florida  33615
South Florida Radiation Oncology, LLC.Wellington, Florida  33449
St. Elizabeth CyberKnife CenterLincoln, Nebraska  68510
CyberKnife Center of New YorkJohnson City, New York  13790
First Dayton Cancer CareDayton, Ohio  45420