Prostate Cancer Early Risk Treated by Radiosurgery Clinical Trial
— RPCROfficial title:
Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial
| NCT number | NCT01226004 |
| Other study ID # | FRRA01 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2010 |
| Est. completion date | July 2020 |
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.
| Status | Recruiting |
| Enrollment | 3000 |
| Est. completion date | July 2020 |
| Est. primary completion date | July 2020 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - pathological diagnosis of prostate cancer - early or intermediate risk Exclusion Criteria: - high risk prostate cancer |
| Country | Name | City | State |
|---|---|---|---|
| United States | Austin CyberKnife | Austin | Texas |
| United States | Saint Vincent Frontier Cancer Center | Billings | Montana |
| United States | CyberKnife of Birmingham | Birmingham | Alabama |
| United States | Penrose Cancer Center | Colorado Springs | Colorado |
| United States | Premier Cancer Centers | Dallas | Texas |
| United States | CyberKnife Center of Chicago | Elmhurst | Illinois |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | The Center for Cancer and Blood Disorders | Fort Worth | Texas |
| United States | California Cancer Care | Fresno | California |
| United States | Benefis Sletten Cancer Institute | Great Falls | Montana |
| United States | Philadelphia CyberKnife | Havertown | Pennsylvania |
| United States | Las Vegas CyberKnife | Henderson | Nevada |
| United States | St. Luke's Medical Center | Houston | Texas |
| United States | St. Mary's Medical Center | Huntington | West Virginia |
| United States | United Health Services | Johnson City | New York |
| United States | First Dayton Cancer Care | Kettering | Ohio |
| United States | Colorado CyberKnife | Lafayette | Colorado |
| United States | Baptist Health | Lexington | Kentucky |
| United States | St. Elizabeth CyberKnife Center | Lincoln | Nebraska |
| United States | Anova Cancer Care | Lone Tree | Colorado |
| United States | WellStar Research Insititute | Marietta | Georgia |
| United States | CyberKnife Center of Miami | Miami | Florida |
| United States | Montana Cancer Institute Foundation | Missoula | Montana |
| United States | University of South Alabama-USA Mitchell Cancer Institute | Mobile | Alabama |
| United States | Naples Radiation Oncology | Naples | Florida |
| United States | Sarah Cannon Cancer Center | Nashville | Tennessee |
| United States | Newport Diagnostic Center | Newport Beach | California |
| United States | Illinois Cyberknife | Park Ridge | Illinois |
| United States | Memorial Cancer Institute CyberKnife Center | Pembroke Pines | Florida |
| United States | Phoenix CyberKnife & Radiation Oncology Center | Phoenix | Arizona |
| United States | Riverview Medical Center | Red Bank | New Jersey |
| United States | Reno CyberKnife | Reno | Nevada |
| United States | The START Center for Cancer Care | San Antonio | Texas |
| United States | Scripps Clinic Radiation Therapy Centers | San Diego | California |
| United States | Spokane CyberKnife | Spokane Valley | Washington |
| United States | CyberKnife Center of South Florida in Stuart | Stuart | Florida |
| United States | CyberKnife Centers of Tampa Bay | Tampa | Florida |
| United States | Cancer Treatment Centers of America | Tulsa | Oklahoma |
| United States | Oklahoma CyberKnife | Tulsa | Oklahoma |
| United States | St. John Medical Center | Tulsa | Oklahoma |
| United States | Skyline Radiation Oncology | Tustin | California |
| United States | Cyberknife of Texas at East Texas Medical Center | Tyler | Texas |
| United States | PeaceHealth Southwest Medical Center | Vancouver | Washington |
| United States | Georgetown University | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Florida Robotic Radiosurgery Association |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | 5 years | ||
| Secondary | Treatment Outcomes | Measurement of surrogate outcomes including IPSS and SHIM scores | 5 years | |
| Secondary | Treatment toxicity | urinary and rectal complications as well as sexual health | 5 years | |
| Secondary | Assess biochemical disease free survival using PSA | 5 years |