Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00619515
• Other study ID #: CASE13807
• Secondary ID: P30CA043703CASE1
• Status: Terminated
• Phase: N/A
• Start date: December 2007
• Est. completion date: February 2013

Study information

• Verified date: August 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	UHHS Chagrin Highlands Medical Center	Cleveland	Ohio
United States	University Suburban Health Center	Cleveland	Ohio
United States	UH-Westlake	Westlake	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0	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.	Within 90 days of completing treatment
Secondary	Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0	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.	Within 5 years of completing treatment
Secondary	Biochemical Disease-free Survival	PSA	Assessed at months 3,6,12,18,24 and every 6 months through 5 years
Secondary	Disease-free Survival (Phoenix and ASTRO Definitions)		Assessed yearly for 5 years
Secondary	Disease-specific Survival		Assessed yearly for 5 years
Secondary	Overall Survival		Assessed yearly for 5 years
Secondary	Rate of Local Failure		Assessed at months 3,6,12,18,24 and every 12 months through 5 years
Secondary	Rate of Distant Failure		Assessed at months 3,6,12,18,24 and every 12 months through 5 years
Secondary	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