Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

N/ATerminatedNCT00619515

Case Comprehensive Cancer Center73 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

questionnaire administrationOTHER

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 imagingPROCEDURE

Undergo fiducial placement imaging

stereotactic radiosurgeryRADIATION

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

Eligibility

Sex: MALEMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

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.

Time frame: Within 90 days of completing treatment

Secondary Outcomes

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.

Time frame: Within 5 years of completing treatment

Biochemical Disease-free Survival

PSA

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

Disease-free Survival (Phoenix and ASTRO Definitions)

Time frame: Assessed yearly for 5 years

Disease-specific Survival

Time frame: Assessed yearly for 5 years

Overall Survival

Time frame: Assessed yearly for 5 years

Rate of Local Failure

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

Rate of Distant Failure

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

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

Data from ClinicalTrials.gov

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