Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

NCT ID: NCT00619515

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2013-02-28

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CyberKnife® stereotactic radiosurgery

Group Type: EXPERIMENTAL

questionnaire administration

Intervention Type: OTHER

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

Intervention Type: PROCEDURE

Undergo fiducial placement imaging

stereotactic radiosurgery

Intervention Type: RADIATION

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

Interventions

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).

Intervention Type: OTHER

implanted fiducial-based imaging

Undergo fiducial placement imaging

Intervention Type: PROCEDURE

stereotactic radiosurgery

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee E. Ponsky, MD

Role: STUDY_CHAIR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

University Suburban Health Center

Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, United States

UH-Westlake

Westlake, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE13807

Identifier Type: OTHER

Identifier Source: secondary_id

CASE13807

Identifier Type: -

Identifier Source: org_study_id