Clinical trial NCT00619515: Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer
Official title: Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-21
Enrollment: 73
Sex: MALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
timeFrame: Within 90 days of completing treatment
Secondary outcomes:
measure: Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0
timeFrame: Within 5 years of completing treatment
measure: Biochemical Disease-free Survival
timeFrame: Assessed at months 3,6,12,18,24 and every 6 months through 5 years
measure: Disease-free Survival (Phoenix and ASTRO Definitions)
timeFrame: Assessed yearly for 5 years
measure: Disease-specific Survival
timeFrame: Assessed yearly for 5 years
measure: Overall Survival
timeFrame: Assessed yearly for 5 years
measure: Rate of Local Failure
timeFrame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years
measure: Rate of Distant Failure
timeFrame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years
measure: 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
timeFrame: Survey at 1,6,12 months and yearly up to 5 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Suburban Health Center
state: Ohio
city: Cleveland
country: United States
facility: UHHS Chagrin Highlands Medical Center
state: Ohio
city: Westlake
country: United States
facility: UH-Westlake
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Lee E. Ponsky, MD
role: STUDY_CHAIR
References: