Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01226004
Previous Study | Return to List | Next Study

Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01226004
Recruitment Status : Recruiting
First Posted : October 21, 2010
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Florida Robotic Radiosurgery Association

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial
Study Start Date : July 2010
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Treatment Outcomes [ Time Frame: 5 years ]
    Measurement of surrogate outcomes including IPSS and SHIM scores

  2. Treatment toxicity [ Time Frame: 5 years ]
    urinary and rectal complications as well as sexual health

  3. Assess biochemical disease free survival using PSA [ Time Frame: 5 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226004


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

Locations
Show Show 44 study locations
Sponsors and Collaborators
Florida Robotic Radiosurgery Association
Investigators
Layout table for investigator information
Principal Investigator: Mark L. Perman, MD South Florida Radiation Oncology, LLC.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Florida Robotic Radiosurgery Association
ClinicalTrials.gov Identifier: NCT01226004    
Other Study ID Numbers: FRRA01
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Keywords provided by Florida Robotic Radiosurgery Association:
radiosurgery
prostate
cancer
 early
intermediate
CyberKnife
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases