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Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)

This study is currently recruiting participants.
Verified March 2015 by Florida Robotic Radiosurgery Association
Sponsor:
ClinicalTrials.gov Identifier:
NCT01226004
First Posted: October 21, 2010
Last Update Posted: March 10, 2015
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.
Collaborator:
Registry for Prostate Cancer Radiosurgery
Information provided by (Responsible Party):
Florida Robotic Radiosurgery Association
  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 ]

Secondary Outcome Measures:
  • 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 ]

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

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
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
Contact: Mark L Perman, MD 772-403-2390 permanmark@gmail.com
Contact: Debra E Freeman, MD 239-262-5168 tbck.md@gmail.com

  Show 44 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

Responsible Party: Florida Robotic Radiosurgery Association
ClinicalTrials.gov Identifier: NCT01226004     History of Changes
Other Study ID Numbers: FRRA01
First Submitted: October 20, 2010
First Posted: October 21, 2010
Last Update Posted: March 10, 2015
Last Verified: March 2015

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