Multi-Institutional Registry for Prostate Cancer Radiosurgery

• Conditions: Prostate Cancer Early Risk Treated by Radiosurgery; Prostate Cancer Intermediate Risk Treated by Radiosurgery

• Registration Number: NCT01226004
• Lead Sponsor: RPCR, Inc.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-06
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 3000

Inclusion Criteria

• pathological diagnosis of prostate cancer
• early or intermediate risk

Exclusion Criteria

• high risk prostate cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (44)

CyberKnife of Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of South Alabama-USA Mitchell Cancer Institute; 🇺🇸 Mobile, Alabama, United States

Phoenix CyberKnife & Radiation Oncology Center; 🇺🇸 Phoenix, Arizona, United States

California Cancer Care; 🇺🇸 Fresno, California, United States

Newport Diagnostic Center; 🇺🇸 Newport Beach, California, United States

Scripps Clinic Radiation Therapy Centers; 🇺🇸 San Diego, California, United States

Skyline Radiation Oncology; 🇺🇸 Tustin, California, United States

Penrose Cancer Center; 🇺🇸 Colorado Springs, Colorado, United States

Colorado CyberKnife; 🇺🇸 Lafayette, Colorado, United States

Anova Cancer Care; 🇺🇸 Lone Tree, Colorado, United States

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