Trial Outcomes & Findings for Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer (NCT NCT00619515)

NCT ID: NCT00619515

Last Updated: 2019-08-22

Results Overview

This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

Within 90 days of completing treatment

Results posted on

2019-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	CyberKnife® Stereotactic Radiosurgery questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms). implanted fiducial-based imaging: Undergo fiducial placement imaging stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
Overall Study STARTED	73
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	73

Reasons for withdrawal

Reasons for withdrawal
Measure	CyberKnife® Stereotactic Radiosurgery questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms). implanted fiducial-based imaging: Undergo fiducial placement imaging stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
Overall Study Study Termination by IRB	73

Baseline Characteristics

Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Within 90 days of completing treatment

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 5 years of completing treatment

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

Late toxicity will be defined as toxicity occurring more than 90 days after treatment. It is graded based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, and RTOG/ECOG definitions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at months 3,6,12,18,24 and every 6 months through 5 years

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

PSA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed yearly for 5 years

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed yearly for 5 years

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed yearly for 5 years

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at months 3,6,12,18,24 and every 12 months through 5 years

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at months 3,6,12,18,24 and every 12 months through 5 years

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Survey at 1,6,12 months and yearly up to 5 years

Population: The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.

Outcome measures

Outcome data not reported

Adverse Events

CyberKnife® Stereotactic Radiosurgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lee Ponsky

Case Comprehensive Cancer Center

Phone: 216-844-4831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place