Prostate Cancer Early Risk Treated by RadiosurgeryRPCRNCT01226004
Multi-Institutional Registry for Prostate Cancer Radiosurgery
An observational study of Prostate Cancer Early Risk Treated by Radiosurgery and Prostate Cancer Intermediate Risk Treated by Radiosurgery, run by RPCR, Inc. at 44 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer Early Risk Treated by Radiosurgery, Prostate Cancer Intermediate Risk Treated by Radiosurgery
- How many people
- 3,000 participants
- Where
- 44 sitesUnited States
- Study dates
- Jul 2010to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men over 18 who have early or intermediate risk prostate cancer and have chosen to undergo radiosurgical treatment
Who may be able to join
- pathological diagnosis of prostate cancer
- early or intermediate risk
Who cannot join
- high risk prostate cancer
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites, 44 recruiting
- Recruiting
Austin CyberKnife
Austin, Texas, 78701
Melissa Cronn, 512-324-8060, mcronn@austincyberknife.com
Paiman Ghafoori, MD
- Recruiting
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Lee McNeely, MD
- Recruiting
CyberKnife of Birmingham
Birmingham, Alabama, 35209
Mike Rickman, 205-877-1754, mike.rickman@tenehealth.com
Fred Dumas, MD
- Recruiting
Penrose Cancer Center
Colorado Springs, Colorado, 80907
Cami Bremer, 719-776-6458, camibremer@centura.org
Jodi Harr, 719-776-5270, jodiharr@centura.org
- Recruiting
Premier Cancer Centers
Dallas, Texas, 75231
Timothy D Nichols, MD, drtimothynichols@premiercancercenters.com
Timothy D Nichols, MD
- Recruiting
CyberKnife Center of Chicago
Elmhurst, Illinois, 60126
Anne Dunlap, 331-221-2050, adunlap@chicagock.com
Andy Su, MD
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Stephanie VanBebber, Stephanie.vanbebber@inova.org
Samir Kanani, MD
- Recruiting
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Gail Wade
Matthew Cavey, MD
- Recruiting
California Cancer Care
Fresno, California, 93720-2950
Bonnie Harkins, RN, OCN, CCRP, bharkins@communitymedical.org
Brent Kane, MD
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59504
Kerstin Leigland, BA, CCRC, KerstinLeigland@benefis.org
Kelly Underhill, MD
- Recruiting
Philadelphia CyberKnife
Havertown, Pennsylvania, 19083
Cindy Winker, 704-770-1177, cwinker@usradiosurgery.com
Michael Good, RN,BSN,MAR, mgood@phillycyberknife.com
- Recruiting
Las Vegas CyberKnife
Henderson, Nevada, 89052
Isis Amoy, 702-233-2200, isis.amoy@usoncology.com
Dan L Curtis, MD
- Recruiting
St. Luke's Medical Center
Houston, Texas, 77030
Catalina Gutierrez, 832-355-7226, cgutierrez@stlukeshealth.org
Cheryl Fullmer, cfullmer@sleh.com
- Recruiting
St. Mary's Medical Center
Huntington, West Virginia, 25702
Beverly Smith, BSN, OCN, bsmith@st-marys.org
Sanjeev Sharma, MD
- Recruiting
United Health Services
Johnson City, New York, 13790
Michelle Karedes, michelle_karedes@uhs.org
Rashid Haq, MD
- Recruiting
First Dayton Cancer Care
Kettering, Ohio, 45420
Kathy Corbett
Mandy Hess, mhess@firstdaytoncancercare.com
- Recruiting
Colorado CyberKnife
Lafayette, Colorado, 80026
Toni Cody, Toni.cody@coloradocyberknife.com
Kelley C Simpson, MD
- Recruiting
Baptist Health
Lexington, Kentucky, 40503
Anne Wray, Anne.Wray@BHSI.com
Alan Beckman, MD
- Recruiting
St. Elizabeth CyberKnife Center
Lincoln, Nebraska, 68510
Kevin Yiee, MD
- Recruiting
Anova Cancer Care
Lone Tree, Colorado, 80124
Gregg Dickerson, MD, 303-396-1414
Greg Dickerson, MD
- Recruiting
WellStar Research Insititute
Marietta, Georgia, 30060
Beth Kost
Mark McLaughlin, MD
- Recruiting
CyberKnife Center of Miami
Miami, Florida, 33156
Gail Suarez, 800-204-0455
James Schwade, MD
- Recruiting
Montana Cancer Institute Foundation
Missoula, Montana, 59802
Holly Frydenlund, Holly.Frydenlund@providence.org
Jeffery Stephenson, MD
- Recruiting
University of South Alabama-USA Mitchell Cancer Institute
Mobile, Alabama, 36688
Roger Ove, MD, PhD, 251-460-7160, rover@usouthal.edu
Roger Ove, MD, PhD
- Recruiting
Naples Radiation Oncology
Naples, Florida, 34119
Debra Freeman, MD, 239-262-5168, dfreeman_md@yahoo.com
Debra Freeman, MD
- Recruiting
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Sheila C Baucum, RN, APN-AOCNS, 615-342-4891, Sheila.Baucum@hcahealthcare.com
James R Gray, MD
- Recruiting
Newport Diagnostic Center
Newport Beach, California, 92660
Amanda Schwer, MD, 800-605-5170, a.schwer@newportdiagnosticcenter.com
Amanda Schwer, MD
- Recruiting
Illinois Cyberknife
Park Ridge, Illinois, 60068
Linda Green, BS,RN, lgreen@illinoisck.com
Arica Hirsch, MD
- Not yet recruiting
Memorial Cancer Institute CyberKnife Center
Pembroke Pines, Florida, 33028
S Sundararaman, MD, 954-844-6868, SSundararaman@mhs.net
Srinath Sundararaman, MD
- Recruiting
Phoenix CyberKnife & Radiation Oncology Center
Phoenix, Arizona, 85028
Monica Baker, ROCC, 602-441-3845, mbaker@pcroc.com
Lauren D Stegman, MD
- Recruiting
Riverview Medical Center
Red Bank, New Jersey, 07701
Stephanie Ullo, 732-530-2468, sullo@meridianhealth.com
Adnan Danish, MD
- Recruiting
Reno CyberKnife
Reno, Nevada, 89503
James Gann, 775-348-9900, JGann@renocyberknife.com
Jonathan Tay, MD
- Recruiting
The START Center for Cancer Care
San Antonio, Texas, 78229
Melissa Blough, PhD, 210-593-5822, melissa.blough@stoh.com
Joaquin G Mira, MD
- Recruiting
Scripps Clinic Radiation Therapy Centers
San Diego, California, 92121
Patrick Linson, MD, 888-542-9237, linson.patrick@scrippshealth.org
Patrick Linson, MD
- Recruiting
Spokane CyberKnife
Spokane Valley, Washington, 99216
Karie-Lynn Kelly, MD, 855-372-9237, kelly@spokanecyberknife.org
Mathew
- Recruiting
CyberKnife Center of South Florida in Stuart
Stuart, Florida, 33996
Mark Perman, MD, 772-403-2390
Mark Perman, MD
- Recruiting
CyberKnife Centers of Tampa Bay
Tampa, Florida, 33615
Debra Freeman, MD, 813-884-7400, dfreeman_md@yahoo.com
Debra Freeman, MD
- Recruiting
St. John Medical Center
Tulsa, Oklahoma, 74104
Candida Barlow, MSN, CTN, RN, 918-744-2345, CANDIDA.BARLOW@sjmc.org
Frederick Willison, MD
- Recruiting
Oklahoma CyberKnife
Tulsa, Oklahoma, 74132
Katherine Wood
kwood@oklahomack.com
- Recruiting
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133
Matt Weaver, BC, CCRC, 918-286-5898, matt.weaver@ctca-hope.com
Wendy Wheaton, wendy.wheaton@ctca-hope.com
- Recruiting
Skyline Radiation Oncology
Tustin, California, 92780
Paul Kim, MD
- Recruiting
Cyberknife of Texas at East Texas Medical Center
Tyler, Texas, 75701
Jeanetta Patterson, RN, BA OCN, jpatterson@etmc.org
Jeffery Gilmore, MD
- Recruiting
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Kara Makin-Bond, 360-514-3940, Kmakinbo@swmedicalcenter.org
Michael Myers, MD
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
Linda Winger, Linda.F.Winger@medstar.net
Sean P Collins, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer Early Risk Treated by Radiosurgery, Prostate Cancer Intermediate Risk Treated by Radiosurgery
- Keywords
- radiosurgery, prostate, cancer, early, intermediate, CyberKnife
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years
Secondary outcomes (3)
Treatment Outcomes
Measurement of surrogate outcomes including IPSS and SHIM scores
Measured: 5 years
Treatment toxicity
urinary and rectal complications as well as sexual health
Measured: 5 years
Assess biochemical disease free survival using PSA
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Early Risk Treated by RadiosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RPCR, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark L. Perman, MD, Principal investigator, South Florida Radiation Oncology, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226004
- Sponsor's protocol ID
- FRRA01
- Acronym
- RPCR
- Status last verified
- Aug 2019
- First submitted
- 20 Oct 2010
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial
- ClinicalTrials.gov ID
- NCT01226004
- Acronym / sponsor ID
- RPCR / FRRA01
- Conditions
- Prostate Cancer Early Risk Treated by Radiosurgery, Prostate Cancer Intermediate Risk Treated by Radiosurgery
- Keywords
- radiosurgery, prostate, cancer, early, intermediate, CyberKnife
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- RPCR, Inc.University, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men over 18 who have early or intermediate risk prostate cancer and have chosen to undergo radiosurgical treatment
Key inclusion criteria (2 listed)
- pathological diagnosis of prostate cancer
- early or intermediate risk
Key exclusion criteria (1 listed)
- high risk prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5 years
3 secondary outcomes
Treatment Outcomes
Time frame: 5 years
Treatment toxicity
Time frame: 5 years
Assess biochemical disease free survival using PSA
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
Related trials for Prostate Cancer Early Risk Treated by Radiosurgery
Not yet recruitingPhase 2
Stereotactic Focal Radiotherapy as an Alternative Treatment to Active Surveillance for Low and Intermediate Risk Prostate Cancer
Macroscopic Tumor Visualized at MRI, Tumor Size Allowing Partial Prostate Treatment Volume
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark L. Perman, MD principal investigator
South Florida Radiation Oncology, LLC.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Early Risk Treated by Radiosurgery and Prostate Cancer Intermediate Risk Treated by Radiosurgery, run by RPCR, Inc. at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark L Perman, MD (772-403-2390, permanmark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.