Multi-Institutional Registry for Prostate Cancer Radiosurgery

NCT ID: NCT01226004

Last Updated: 2019-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* pathological diagnosis of prostate cancer
* early or intermediate risk

Exclusion Criteria

* high risk prostate cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RPCR, Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark L. Perman, MD

Role: PRINCIPAL_INVESTIGATOR

South Florida Radiation Oncology, LLC.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CyberKnife of Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

University of South Alabama-USA Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status RECRUITING

Phoenix CyberKnife & Radiation Oncology Center

Phoenix, Arizona, United States

Site Status RECRUITING

California Cancer Care

Fresno, California, United States

Site Status RECRUITING

Newport Diagnostic Center

Newport Beach, California, United States

Site Status RECRUITING

Scripps Clinic Radiation Therapy Centers

San Diego, California, United States

Site Status RECRUITING

Skyline Radiation Oncology

Tustin, California, United States

Site Status RECRUITING

Penrose Cancer Center

Colorado Springs, Colorado, United States

Site Status RECRUITING

Colorado CyberKnife

Lafayette, Colorado, United States

Site Status RECRUITING

Anova Cancer Care

Lone Tree, Colorado, United States

Site Status RECRUITING

Georgetown University

Washington D.C., District of Columbia, United States

Site Status RECRUITING

CyberKnife Center of Miami

Miami, Florida, United States

Site Status RECRUITING

Naples Radiation Oncology

Naples, Florida, United States

Site Status RECRUITING

Memorial Cancer Institute CyberKnife Center

Pembroke Pines, Florida, United States

Site Status NOT_YET_RECRUITING

CyberKnife Center of South Florida in Stuart

Stuart, Florida, United States

Site Status RECRUITING

CyberKnife Centers of Tampa Bay

Tampa, Florida, United States

Site Status RECRUITING

WellStar Research Insititute

Marietta, Georgia, United States

Site Status RECRUITING

CyberKnife Center of Chicago

Elmhurst, Illinois, United States

Site Status RECRUITING

Illinois Cyberknife

Park Ridge, Illinois, United States

Site Status RECRUITING

Baptist Health

Lexington, Kentucky, United States

Site Status RECRUITING

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Montana Cancer Institute Foundation

Missoula, Montana, United States

Site Status RECRUITING

St. Elizabeth CyberKnife Center

Lincoln, Nebraska, United States

Site Status RECRUITING

Las Vegas CyberKnife

Henderson, Nevada, United States

Site Status RECRUITING

Reno CyberKnife

Reno, Nevada, United States

Site Status RECRUITING

Riverview Medical Center

Red Bank, New Jersey, United States

Site Status RECRUITING

United Health Services

Johnson City, New York, United States

Site Status RECRUITING

First Dayton Cancer Care

Kettering, Ohio, United States

Site Status RECRUITING

St. John Medical Center

Tulsa, Oklahoma, United States

Site Status RECRUITING

Oklahoma CyberKnife

Tulsa, Oklahoma, United States

Site Status RECRUITING

Cancer Treatment Centers of America

Tulsa, Oklahoma, United States

Site Status RECRUITING

Philadelphia CyberKnife

Havertown, Pennsylvania, United States

Site Status RECRUITING

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Austin CyberKnife

Austin, Texas, United States

Site Status RECRUITING

Premier Cancer Centers

Dallas, Texas, United States

Site Status RECRUITING

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Site Status RECRUITING

St. Luke's Medical Center

Houston, Texas, United States

Site Status RECRUITING

The START Center for Cancer Care

San Antonio, Texas, United States

Site Status RECRUITING

Cyberknife of Texas at East Texas Medical Center

Tyler, Texas, United States

Site Status RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status RECRUITING

Spokane CyberKnife

Spokane Valley, Washington, United States

Site Status RECRUITING

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status RECRUITING

St. Mary's Medical Center

Huntington, West Virginia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mark L Perman, MD

Role: CONTACT

772-403-2390

Debra E Freeman, MD

Role: CONTACT

239-262-5168

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mike Rickman

Role: primary

205-877-1754

Roger Ove, MD, PhD

Role: primary

251-460-7160

Monica Baker, ROCC

Role: primary

602-441-3845

Bonnie Harkins, RN, OCN, CCRP

Role: primary

Amanda Schwer, MD

Role: primary

800-605-5170

Patrick Linson, MD

Role: primary

888-542-9237

Cami Bremer

Role: primary

719-776-6458

Jodi Harr

Role: backup

719-776-5270

Toni Cody

Role: primary

Gregg Dickerson, MD

Role: primary

303-396-1414

Linda Winger

Role: primary

Gail Suarez

Role: primary

800-204-0455

Debra Freeman, MD

Role: primary

239-262-5168

S Sundararaman, MD

Role: primary

954-844-6868

Mark Perman, MD

Role: primary

772-403-2390

Debra Freeman, MD

Role: primary

813-884-7400

Beth Kost

Role: primary

Anne Dunlap

Role: primary

331-221-2050

Linda Green, BS,RN

Role: primary

Anne Wray

Role: primary

Kerstin Leigland, BA, CCRC

Role: primary

Holly Frydenlund

Role: primary

Isis Amoy

Role: primary

702-233-2200

James Gann

Role: primary

775-348-9900

Stephanie Ullo

Role: primary

732-530-2468

Michelle Karedes

Role: primary

Kathy Corbett

Role: primary

Mandy Hess

Role: backup

Candida Barlow, MSN, CTN, RN

Role: primary

918-744-2345

Katherine Wood

Role: primary

Role: backup

Matt Weaver, BC, CCRC

Role: primary

918-286-5898

Wendy Wheaton

Role: backup

Cindy Winker

Role: primary

704-770-1177

Michael Good, RN,BSN,MAR

Role: backup

Sheila C Baucum, RN, APN-AOCNS

Role: primary

615-342-4891

Melissa Cronn

Role: primary

512-324-8060

Timothy D Nichols, MD

Role: primary

Gail Wade

Role: primary

Catalina Gutierrez

Role: primary

832-355-7226

Cheryl Fullmer

Role: backup

Melissa Blough, PhD

Role: primary

210-593-5822

Jeanetta Patterson, RN, BA OCN

Role: primary

Stephanie VanBebber

Role: primary

Karie-Lynn Kelly, MD

Role: primary

855-372-9237

Mathew

Role: backup

Kara Makin-Bond

Role: primary

360-514-3940

Beverly Smith, BSN, OCN

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FRRA01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prostate Advances in Comparative Evidence
NCT01584258 ACTIVE_NOT_RECRUITING PHASE3