Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer
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.
Interventions
OTHERquestionnaire 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).
PROCEDUREimplanted fiducial-based imaging
Undergo fiducial placement imaging
RADIATIONstereotactic radiosurgery
Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Biochemical Disease-free Survival | Assessed at months 3,6,12,18,24 and every 6 months through 5 years | PSA |
| Disease-free Survival (Phoenix and ASTRO Definitions) | Assessed yearly for 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 | Survey at 1,6,12 months and yearly up to 5 years | — |
| Overall Survival | Assessed yearly for 5 years | — |
| Rate of Local Failure | Assessed at months 3,6,12,18,24 and every 12 months through 5 years | — |
| Rate of Distant Failure | Assessed at months 3,6,12,18,24 and every 12 months through 5 years | — |
| Disease-specific Survival | Assessed yearly for 5 years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CyberKnife® Stereotactic Radiosurgery 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. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Termination by IRB | 73 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Within 90 days of completing treatment
Population: 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.
Secondary
Biochemical Disease-free Survival
PSA
Time frame: Assessed at months 3,6,12,18,24 and every 6 months through 5 years
Population: 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.
Secondary
Disease-free Survival (Phoenix and ASTRO Definitions)
Time frame: Assessed yearly for 5 years
Population: 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.
Secondary
Disease-specific Survival
Time frame: Assessed yearly for 5 years
Population: 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.
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.
Time frame: Within 5 years of completing treatment
Population: 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.
Secondary
Overall Survival
Time frame: Assessed yearly for 5 years
Population: 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.
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
Time frame: Survey at 1,6,12 months and yearly up to 5 years
Population: 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.
Secondary
Rate of Distant Failure
Time frame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years
Population: 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.
Secondary
Rate of Local Failure
Time frame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years
Population: 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.