Multi-Institutional Registry for Prostate Cancer Radiosurgery

Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01226004

Acronym

RPCR

Enrollment

3000

Registered

2010-10-21

Start date

2010-07-31

Completion date

2020-07-31

Last updated

2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

radiosurgery, prostate, cancer, early, intermediate, CyberKnife

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* pathological diagnosis of prostate cancer * early or intermediate risk

Exclusion criteria

* high risk prostate cancer

Design outcomes

Primary

Measure	Time frame
Overall survival	5 years

Secondary

Measure	Time frame	Description
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	—

Countries

United States

Contacts

Primary ContactMark L Perman, MD

permanmark@gmail.com772-403-2390

Backup ContactDebra E Freeman, MD

tbck.md@gmail.com239-262-5168

Outcome results