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Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)

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ClinicalTrials.gov Identifier: NCT01226004
Recruitment Status : Recruiting
First Posted : October 21, 2010
Last Update Posted : March 10, 2015
Sponsor:
Collaborator:
Registry for Prostate Cancer Radiosurgery
Information provided by (Responsible Party):
Florida Robotic Radiosurgery Association

Tracking Information
First Submitted Date October 20, 2010
First Posted Date October 21, 2010
Last Update Posted Date March 10, 2015
Study Start Date July 2010
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2013)
Overall survival [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: October 20, 2010)
Overall survival [ Time Frame: three years ]
Change History Complete list of historical versions of study NCT01226004 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 24, 2013)
  • Treatment Outcomes [ Time Frame: 5 years ]
    Measurement of surrogate outcomes including IPSS and SHIM scores
  • Treatment toxicity [ Time Frame: 5 years ]
    urinary and rectal complications as well as sexual health
  • Assess biochemical disease free survival using PSA [ Time Frame: 5 years ]
Original Secondary Outcome Measures
 (submitted: October 20, 2010)
  • Treatment Outcomes [ Time Frame: Three years ]
    Measurement of surrogate outcomes including IPSS and SHIM scores
  • Treatment toxicity [ Time Frame: 3 years ]
    urinary and rectal complications as well as sexual health
  • Assess biochemical disease free survival using PSA [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-Institutional Registry for Prostate Cancer Radiosurgery
Official Title Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Prostate Cancer Early Risk Treated by Radiosurgery
  • Prostate Cancer Intermediate Risk Treated by Radiosurgery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 24, 2013)
3000
Original Estimated Enrollment
 (submitted: October 20, 2010)
300
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • pathological diagnosis of prostate cancer
  • early or intermediate risk

Exclusion Criteria:

  • high risk prostate cancer
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mark L Perman, MD 772-403-2390 permanmark@gmail.com
Contact: Debra E Freeman, MD 239-262-5168 tbck.md@gmail.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01226004
Other Study ID Numbers FRRA01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Florida Robotic Radiosurgery Association
Study Sponsor Florida Robotic Radiosurgery Association
Collaborators Registry for Prostate Cancer Radiosurgery
Investigators
Principal Investigator: Mark L. Perman, MD South Florida Radiation Oncology, LLC.
PRS Account Florida Robotic Radiosurgery Association
Verification Date March 2015