Trial record 15 of 20 for:    cyberknife, prostate cancer

Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)

This study is currently recruiting participants.
Verified December 2013 by Florida Robotic Radiosurgery Association
Sponsor:
Collaborator:
Registry for Prostate Cancer Radiosurgery
Information provided by (Responsible Party):
Florida Robotic Radiosurgery Association
ClinicalTrials.gov Identifier:
NCT01226004
First received: October 20, 2010
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition
Prostate Cancer Early Risk Treated by Radiosurgery
Prostate Cancer Intermediate Risk Treated by Radiosurgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial

Resource links provided by NLM:


Further study details as provided by Florida Robotic Radiosurgery Association:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment Outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Measurement of surrogate outcomes including IPSS and SHIM scores

  • Treatment toxicity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    urinary and rectal complications as well as sexual health

  • Assess biochemical disease free survival using PSA [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: July 2010
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • pathological diagnosis of prostate cancer
  • early or intermediate risk

Exclusion Criteria:

  • high risk prostate cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226004

Contacts
Contact: Mark L Perman, MD 772-403-2390 permanmark@gmail.com
Contact: Debra E Freeman, MD 239-262-5168 tbck.md@gmail.com

  Show 46 Study Locations
Sponsors and Collaborators
Florida Robotic Radiosurgery Association
Registry for Prostate Cancer Radiosurgery
Investigators
Principal Investigator: Mark L. Perman, MD South Florida Radiation Oncology, LLC.
  More Information

No publications provided

Responsible Party: Florida Robotic Radiosurgery Association
ClinicalTrials.gov Identifier: NCT01226004     History of Changes
Other Study ID Numbers: FRRA01
Study First Received: October 20, 2010
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Robotic Radiosurgery Association:
radiosurgery
prostate
cancer
early
intermediate
CyberKnife

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 20, 2014