Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Accuray Incorporated
- Enrollment
- 379
- Locations
- 23
- Primary Endpoint
- Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
Study Overview
Brief Summary
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
Detailed Description
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must be at least 18 years of age
- •Histologically proven prostate adenocarcinoma
- •Patients belonging in one of the following risk groups:
- •Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml
- •Prostate volume: ≤ 100 cc
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria
- •Prior prostatectomy or cryotherapy of the prostate
- •Prior radiotherapy to the prostate or lower pelvis
- •Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
- •Chemotherapy for a malignancy in the last 5 years
- •History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
- •Hormone ablation for two months prior to enrollment, or during treatment.
Arms & Interventions
CyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer.
Intervention: CyberKnife Stereotactic Radiosurgery (Radiation)
Outcomes
Primary Outcomes
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
Time Frame: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.
Biochemical Disease-Free Survival (bDFS)
Time Frame: Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.
Secondary Outcomes
- Disease Control and Survival Outcomes(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: EPIC-26 Sexual(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: EPIC-26 Bowel(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)