Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Overall survival [ Time Frame: three years ] [ Designated as safety issue: No ]
- Treatment Outcomes [ Time Frame: Three years ] [ Designated as safety issue: No ]Measurement of surrogate outcomes including IPSS and SHIM scores
- Treatment toxicity [ Time Frame: 3 years ] [ Designated as safety issue: No ]urinary and rectal complications as well as sexual health
- Assess biochemical disease free survival using PSA [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Men over 18 who have early or intermediate risk prostate cancer and have chosen to undergo radiosurgical treatment
Inclusion Criteria:
- pathological diagnosis of prostate cancer
- early or intermediate risk
Exclusion Criteria:
- high risk prostate cancer
Contacts and Locations| Contact: Mark L Perman, MD | 772-403-2390 | permanmark@gmail.com |
| United States, California | |
| Newport Diagnostic Center | Recruiting |
| Newport Beach, California, United States, 92660 | |
| Contact: Amanda Schwer, MD 800-605-5170 | |
| Principal Investigator: Amanda Schwer, MD | |
| Pasadena CyberKnife Center | Recruiting |
| Pasadena, California, United States, 91105 | |
| Contact: N Chu | |
| Principal Investigator: Albert Mak, MD | |
| CyberKnife of Southern California at Vista | Recruiting |
| Vista, California, United States, 92081 | |
| Contact: Patrick Linson, MD 888-542-9237 | |
| Principal Investigator: Patrick Linson, MD | |
| United States, Colorado | |
| Rocky Mountain CyberKnife | Recruiting |
| Boulder, Colorado, United States, 80304 | |
| Contact: J Horsely 303-448-4620 JHorsley@usradiosurgery.com | |
| Principal Investigator: Lee McNeely, M.D. | |
| Penrose Cancer Center | Recruiting |
| Colorado Springs, Colorado, United States, 80907 | |
| Contact: Barry T. Switzer 719-776-5281 BarrySwitzer@centura.org | |
| Principal Investigator: Anuj Peddada, M.D. | |
| Denver CyberKnife | Recruiting |
| Denver, Colorado, United States, 80124 | |
| Contact: Gregg Dickerson, MD 303-396-1414 | |
| Principal Investigator: Greg Dickerson, MD | |
| Colorado CyberKnife | Recruiting |
| Lafayette, Colorado, United States, 80026 | |
| Contact: C. K. Simpson, MD 303-926-9800 kelley.simpson@coloradocyberknife.com | |
| Principal Investigator: C. K. Simpson, MD | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Sean P Collins, MD, PhD 202-444-3062 spc9@gunet.georgetown.edu | |
| Principal Investigator: Sean P Collins, MD, PhD | |
| United States, Florida | |
| JFK Hospital | Recruiting |
| Atlantis, Florida, United States, 33462 | |
| Contact: Jamie Kosik 561-965-7300 | |
| Principal Investigator: George Hatoum, M.D. | |
| CyberKnife Centers of Tampa Bay at Brandon | Recruiting |
| Brandon, Florida, United States, 33511 | |
| Contact: Debra Freeman, MD 813-844-6868 | |
| Principal Investigator: Debra Freeman, MD | |
| North Broward Medical Center | Recruiting |
| Deerfield Beach, Florida, United States, 33064 | |
| Contact: Amanda Haerry 954-941-8300 | |
| Coastal CyberKnife | Recruiting |
| Ft. Pierce, Florida, United States, 34982 | |
| Contact: Scott Allen 772-293-0377 | |
| Principal Investigator: William Crook, MD | |
| Cancer Care Centers of Brevard | Recruiting |
| Melbourne, Florida, United States, 32901 | |
| Contact: Carolyn Hall 321-951-9991 | |
| Principal Investigator: Silas Charles, MD | |
| CyberKnife Center of Miami | Recruiting |
| Miami, Florida, United States, 33156 | |
| Contact: Gail Suarez 800-204-0455 | |
| Principal Investigator: James Schwade, MD | |
| University of Miami/Sylvester Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: A Reyes 305-243-4320 | |
| Principal Investigator: Mathew Abramowitz, MD | |
| CyberKnife Institute at Mercy Hospital | Recruiting |
| Miami, Florida, United States, 33133 | |
| Contact: K Jenkins KJenkins@mercymiami.org | |
| Principal Investigator: Raul Ravelo, MD | |
| CyberKnife Center of Palm Beach | Recruiting |
| Palm Beach Gardens, Florida, United States, 33410 | |
| Contact: Gail Suarez 800-204-0455 | |
| Principal Investigator: James Schwade, MD | |
| Memorial Cancer Institute CyberKnife Center | Not yet recruiting |
| Pembroke Pines, Florida, United States, 33028 | |
| Contact: S Sundararaman, MD 954-844-6868 | |
| Principal Investigator: Srinath Sundararaman, MD | |
| CyberKnife Center of South Florida in Stuart | Recruiting |
| Stuart, Florida, United States, 33996 | |
| Contact: Mark Perman, MD 772-403-2390 | |
| Principal Investigator: Mark Perman, MD | |
| CyberKnife Centers of Tampa Bay | Recruiting |
| Tampa, Florida, United States, 33615 | |
| Contact: Debra Freeman, MD 813-884-7400 | |
| Principal Investigator: Debra Freeman, MD | |
| South Florida Radiation Oncology, LLC. | Recruiting |
| Wellington, Florida, United States, 33449 | |
| Contact: Anthony Addesa, MD 561-795-9845 | |
| Principal Investigator: Kishore Dass, MD | |
| Principal Investigator: Anthony Addesa, MD | |
| United States, Nebraska | |
| St. Elizabeth CyberKnife Center | Recruiting |
| Lincoln, Nebraska, United States, 68510 | |
| Contact: A Akins 402-219-8000 | |
| Principal Investigator: Kevin Yiee, MD | |
| United States, New York | |
| CyberKnife Center of New York | Recruiting |
| Johnson City, New York, United States, 13790 | |
| Contact: Martha Nelson 607-763-6666 | |
| Principal Investigator: Rashid Haq, MD | |
| United States, Ohio | |
| First Dayton Cancer Care | Recruiting |
| Dayton, Ohio, United States, 45420 | |
| Contact: Edward Hughes, MD 937-293-2273 | |
| Contact: Jo Hayes | |
| Principal Investigator: Edward Hughes, MD | |
| United States, Texas | |
| St. Luke's Episcopal Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Catalina Gutierrez 832-355-7226 cgutierrez@sleh.com | |
| Principal Investigator: L. Steven Carpenter, MD | |
| Principal Investigator: | Mark L. Perman, MD | South Florida Radiation Oncology, LLC. |
More Information
No publications provided
| Responsible Party: | Florida Robotic Radiosurgery Association |
| ClinicalTrials.gov Identifier: | NCT01226004 History of Changes |
| Other Study ID Numbers: | FRRA01 |
| Study First Received: | October 20, 2010 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on June 18, 2013