Multi-Institutional Registry for Prostate Cancer Radiosur... | NCT01226004

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 2020Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Oct 20, 2010

First Submission Date that Met QC Criteria

Oct 20, 2010

First Posted Date

Oct 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2019

Last Update Posted Date

Aug 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

RPCR, Inc.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

radiosurgery
prostate
cancer
early
intermediate
CyberKnife

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		5 years

Secondary Outcomes

Measure	Description	Time Frame
Treatment Outcomes	Measurement of surrogate outcomes including IPSS and SHIM scores	5 years
Treatment toxicity	urinary and rectal complications as well as sexual health

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pathological diagnosis of prostate cancer
early or intermediate risk

Exclusion Criteria:

high risk prostate cancer

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Men over 18 who have early or intermediate risk prostate cancer and have chosen to undergo radiosurgical treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mark L Perman, MD	Contact	772-403-2390		permanmark@gmail.com
Debra E Freeman, MD	Contact	239-262-5168		tbck.md@gmail.com

Overall Officials

Name	Affiliation	Role
Mark L. Perman, MD	South Florida Radiation Oncology, LLC.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CyberKnife of Birmingham	Recruiting	Birmingham	Alabama	35209	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.