Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00619515
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 73
• Locations: 4
• Arm: 1
• Duration (Months): 62.1
• Patients Per Site: 18.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: questionnaire administration; Procedure: implanted fiducial-based imaging; Radiation: stereotactic radiosurgery	N/A

Detailed Description

OBJECTIVES:

Primary

• To estimate in both low- and low-to-intermediate-risk groups of patients with prostate cancer, the rate of acute toxicities observed during the 5 years following CyberKnife® stereotactic radiosurgery (SRS).

Secondary

• To estimate the rate of late grade 3-5 toxicities after SRS in these patients.

• To measure biochemical disease-free survival of patients treated with this therapy.

• To measure rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival of patients treated with this therapy.

• To measure quality of life in generic and organ-specific domains in patients treated with this therapy.

• To evaluate imaging modalities and their potential role in the detection of prostate cancer persistence, recurrence, and/or progression in patients treated with this therapy.

OUTLINE: Patients are stratified according to risk group (low risk vs low/intermediate risk).

Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.

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).

After completion of study therapy, patients are followed for up to 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: CyberKnife® stereotactic radiosurgery

Other: 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).; Procedure: implanted fiducial-based imaging; Undergo fiducial placement imaging; Radiation: stereotactic radiosurgery; Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.

Outcome Measures

Primary Outcome Measures

1. Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0 [Within 90 days of completing treatment]

   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.

Secondary Outcome Measures

1. Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0 [Within 5 years of completing treatment]

   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.

2. Biochemical Disease-free Survival [Assessed at months 3,6,12,18,24 and every 6 months through 5 years]

   PSA

3. Disease-free Survival (Phoenix and ASTRO Definitions) [Assessed yearly for 5 years]

4. Disease-specific Survival [Assessed yearly for 5 years]

5. Overall Survival [Assessed yearly for 5 years]

6. Rate of Local Failure [Assessed at months 3,6,12,18,24 and every 12 months through 5 years]

7. Rate of Distant Failure [Assessed at months 3,6,12,18,24 and every 12 months through 5 years]

8. Quality of Life as Measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices [Survey at 1,6,12 months and yearly up to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 120 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Disease confirmed by biopsy within 1 year of study entry

• Gleason score 2-7(3+4)

• Clinical stage T1a or T2b, N0 or NX, M0 or MX

• T- stage and N-stage determined by physical exam and available imaging studies (i.e., ultrasound, CT scan, and/or MRI)

• M-stage determined by physical exam, CT scan, and/or MRI

• Bone scan is not required unless clinical findings suggest possible osseous metastases

• PSA ≤ 10 ng/mL within the past 60 days

• At risk for recurrence, as defined by 1 of the following risk groups:

• Low-risk, defined by the following combination:

• Stage T1a-T2a, Gleason 2-6, and PSA ≤ 10 ng/mL

• Low- to-Intermediate-risk, defined by either of the following combinations:

• Stage T2b, Gleason 2-6, and PSA ≤ 10 ng/mL

• Stage T2b, Gleason 3+4=7, and PSA ≤ 10 ng/mL

• Prostate volume must be ≤ 100 cc

• Determined by measurement from CT scan or ultrasound within the past 90 days or within the past 14 days if hormone therapy is given

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion

PRIOR CONCURRENT THERAPY:

• No prior definitive therapy for prostate cancer, including prostatectomy, cryotherapy, or radiotherapy to the prostate or lower pelvis

• No more than 6 months of hormone ablation for gland downsizing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
2	University Suburban Health Center	Cleveland	Ohio	United States	44121
3	UHHS Chagrin Highlands Medical Center	Cleveland	Ohio	United States	44122
4	UH-Westlake	Westlake	Ohio	United States	44145

Sponsors and Collaborators

• Case Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Study Chair: Lee E. Ponsky, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00619515
• Other Study ID Numbers: CASE13807; P30CA043703; CASE13807
• First Posted: Feb 21, 2008
• Last Update Posted: Aug 22, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Case Comprehensive Cancer Center: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Period Title: Overall Study
STARTED	73
COMPLETED	0
NOT COMPLETED	73

Baseline Characteristics

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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 Participants	0
Age (years) []
Sex: Female, Male () []
Female
Male
Ethnicity (NIH/OMB) () []
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
Description	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.
Time Frame	Within 90 days of completing treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

2. Secondary Outcome

Title	Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0
Description	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.
Time Frame	Within 5 years of completing treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

3. Secondary Outcome

Title	Biochemical Disease-free Survival
Description	PSA
Time Frame	Assessed at months 3,6,12,18,24 and every 6 months through 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

4. Secondary Outcome

Title	Disease-free Survival (Phoenix and ASTRO Definitions)
Time Frame	Assessed yearly for 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

5. Secondary Outcome

Title	Disease-specific Survival
Time Frame	Assessed yearly for 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

6. Secondary Outcome

Title	Overall Survival
Time Frame	Assessed yearly for 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

7. Secondary Outcome

Title	Rate of Local Failure
Time Frame	Assessed at months 3,6,12,18,24 and every 12 months through 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

8. Secondary Outcome

Title	Rate of Distant Failure
Time Frame	Assessed at months 3,6,12,18,24 and every 12 months through 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

9. Secondary Outcome

Title	Quality of Life as Measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices
Time Frame	Survey at 1,6,12 months and yearly up to 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
Measure Participants	0

Adverse Events

Time Frame	The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
Adverse Event Reporting Description	The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
Arm/Group Title	CyberKnife® Stereotactic Radiosurgery
Arm/Group Description	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.
All Cause Mortality
	CyberKnife® Stereotactic Radiosurgery
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	CyberKnife® Stereotactic Radiosurgery
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	CyberKnife® Stereotactic Radiosurgery
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.