Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR)

• ClinicalTrials.gov Identifier: NCT01226004
• Recruitment Status: Unknown
• First Posted: October 21, 2010
• Last Update Posted: August 6, 2019
• Sponsor: RPCR, Inc.
• Information provided by (Responsible Party): RPCR, Inc.

Tracking Information

• First Submitted Date: October 20, 2010
• First Posted Date: October 21, 2010
• Last Update Posted Date: August 6, 2019
• Study Start Date: July 2010
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 24, 2013): Overall survival [ Time Frame: 5 years ]
• Original Primary Outcome Measures (submitted: October 20, 2010): Overall survival [ Time Frame: three years ]

Current Secondary Outcome Measures (submitted: October 24, 2013)

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

Original Secondary Outcome Measures (submitted: October 20, 2010)

• Treatment Outcomes [ Time Frame: Three years ]
  Measurement of surrogate outcomes including IPSS and SHIM scores
• Treatment toxicity [ Time Frame: 3 years ]
  urinary and rectal complications as well as sexual health
• Assess biochemical disease free survival using PSA [ Time Frame: 3 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multi-Institutional Registry for Prostate Cancer Radiosurgery
• Official Title: Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial
• Brief 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. 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

Condition

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

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 24, 2013): 3000
• Original Estimated Enrollment (submitted: October 20, 2010): 300
• Estimated Study Completion Date: July 2020
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• pathological diagnosis of prostate cancer
• early or intermediate risk

Exclusion Criteria:

• high risk prostate cancer

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01226004
• Other Study ID Numbers: FRRA01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: RPCR, Inc.
• Original Responsible Party: Mark Perman, President, Florida Robotic Radiosurgery Association
• Current Study Sponsor: RPCR, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: RPCR, Inc.
• Verification Date: August 2019