Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)

August 2, 2019 updated by: RPCR, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • CyberKnife of Birmingham
        • Contact:
        • Principal Investigator:
          • Fred Dumas, MD
      • Mobile, Alabama, United States, 36688
        • Recruiting
        • University of South Alabama-USA Mitchell Cancer Institute
        • Contact:
        • Principal Investigator:
          • Roger Ove, MD, PhD
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Recruiting
        • Phoenix CyberKnife & Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Lauren D Stegman, MD
    • California
      • Fresno, California, United States, 93720-2950
        • Recruiting
        • California Cancer Care
        • Contact:
        • Principal Investigator:
          • Brent Kane, MD
      • Newport Beach, California, United States, 92660
      • San Diego, California, United States, 92121
        • Recruiting
        • Scripps Clinic Radiation Therapy Centers
        • Contact:
        • Principal Investigator:
          • Patrick Linson, MD
      • Tustin, California, United States, 92780
        • Recruiting
        • Skyline Radiation Oncology
        • Principal Investigator:
          • Paul Kim, MD
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Penrose Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anuj Peddada, M.D.
      • Lafayette, Colorado, United States, 80026
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Anova Cancer Care
        • Contact:
          • Gregg Dickerson, MD
          • Phone Number: 303-396-1414
        • Principal Investigator:
          • Greg Dickerson, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University
        • Contact:
        • Principal Investigator:
          • Sean P Collins, MD, PhD
    • Florida
      • Miami, Florida, United States, 33156
        • Recruiting
        • CyberKnife Center of Miami
        • Contact:
          • Gail Suarez
          • Phone Number: 800-204-0455
        • Principal Investigator:
          • James Schwade, MD
      • Naples, Florida, United States, 34119
        • Recruiting
        • Naples Radiation Oncology
        • Contact:
      • Pembroke Pines, Florida, United States, 33028
        • Not yet recruiting
        • Memorial Cancer Institute CyberKnife Center
        • Contact:
        • Principal Investigator:
          • Srinath Sundararaman, MD
      • Stuart, Florida, United States, 33996
        • Recruiting
        • CyberKnife Center of South Florida in Stuart
      • Tampa, Florida, United States, 33615
        • Recruiting
        • CyberKnife Centers of Tampa Bay
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • WellStar Research Insititute
        • Contact:
          • Beth Kost
        • Principal Investigator:
          • Mark McLaughlin, MD
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • CyberKnife Center of Chicago
        • Contact:
        • Principal Investigator:
          • Andy Su, MD
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Illinois Cyberknife
        • Contact:
        • Principal Investigator:
          • Arica Hirsch, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health
        • Contact:
        • Principal Investigator:
          • Alan Beckman, MD
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Saint Vincent Frontier Cancer Center
        • Principal Investigator:
          • Lee McNeely, MD
      • Great Falls, Montana, United States, 59504
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Contact:
        • Principal Investigator:
          • Kelly Underhill, MD
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Montana Cancer Institute Foundation
        • Contact:
        • Principal Investigator:
          • Jeffery Stephenson, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Recruiting
        • St. Elizabeth CyberKnife Center
        • Principal Investigator:
          • Kevin Yiee, MD
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Las Vegas CyberKnife
        • Contact:
        • Principal Investigator:
          • Dan L Curtis, MD
      • Reno, Nevada, United States, 89503
        • Recruiting
        • Reno CyberKnife
        • Contact:
        • Principal Investigator:
          • Jonathan Tay, MD
    • New Jersey
      • Red Bank, New Jersey, United States, 07701
        • Recruiting
        • Riverview Medical Center
        • Contact:
        • Principal Investigator:
          • Adnan Danish, MD
    • New York
      • Johnson City, New York, United States, 13790
        • Recruiting
        • United Health Services
        • Contact:
        • Principal Investigator:
          • Rashid Haq, MD
    • Ohio
      • Kettering, Ohio, United States, 45420
        • Recruiting
        • First Dayton Cancer Care
        • Contact:
          • Kathy Corbett
        • Contact:
        • Principal Investigator:
          • Edward Hughes, MD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • St. John Medical Center
        • Contact:
        • Principal Investigator:
          • Frederick Willison, MD
      • Tulsa, Oklahoma, United States, 74132
        • Recruiting
        • Oklahoma CyberKnife
        • Contact:
          • Katherine Wood
        • Contact:
        • Principal Investigator:
          • Diane Heaton, MD
      • Tulsa, Oklahoma, United States, 74133
    • Pennsylvania
      • Havertown, Pennsylvania, United States, 19083
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Cancer Center
        • Contact:
        • Principal Investigator:
          • James R Gray, MD
    • Texas
      • Austin, Texas, United States, 78701
        • Recruiting
        • Austin CyberKnife
        • Contact:
        • Principal Investigator:
          • Paiman Ghafoori, MD
      • Dallas, Texas, United States, 75231
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • The Center for Cancer and Blood Disorders
        • Contact:
          • Gail Wade
        • Principal Investigator:
          • Matthew Cavey, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • St. Luke's Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • L. Steven Carpenter, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The START Center for Cancer Care
        • Contact:
        • Principal Investigator:
          • Joaquin G Mira, MD
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Cyberknife of Texas at East Texas Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffery Gilmore, MD
    • Virginia
      • Falls Church, Virginia, United States, 22042
    • Washington
      • Spokane Valley, Washington, United States, 99216
        • Recruiting
        • Spokane CyberKnife
        • Contact:
        • Contact:
          • Mathew
        • Principal Investigator:
          • Karie- Lynn Kelly, MD
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Myers, MD
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • Recruiting
        • St. Mary's Medical Center
        • Contact:
        • Principal Investigator:
          • Sanjeev Sharma, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

Inclusion Criteria:

  • pathological diagnosis of prostate cancer
  • early or intermediate risk

Exclusion Criteria:

  • high risk prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Outcomes
Time Frame: 5 years
Measurement of surrogate outcomes including IPSS and SHIM scores
5 years
Treatment toxicity
Time Frame: 5 years
urinary and rectal complications as well as sexual health
5 years
Assess biochemical disease free survival using PSA
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RPCR, Inc.

Investigators

  • Principal Investigator: Mark L. Perman, MD, South Florida Radiation Oncology, LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRRA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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