Clinical trial · Interventional
CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the side effects and how effective CyberKnife stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with low to intermediate risk prostate cancer and to evaluate the effect of this treatment on the patients' quality of life over time.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife Stereotactic Ablative Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CyberKnife
- description
- CyberKnife Stereotactic Ablative Body Radiation Therapy
- interventionNames
- Radiation: CyberKnife Stereotactic Ablative Body Radiation Therapy
Primary outcomes (1)
- measure
- CyberKnife Toxicities in Prostate Cancer
- timeFrame
- 5 years
- description
- The primary safety goal of this study is to estimate, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed following CyberKnife SABR for prostate cancer. The primary efficacy goal is to document the rate of biochemical Disease-Free Survival (bDFS) using the Phoenix and ASTRO definitions, at 5 years.
Secondary outcomes (1)
- measure
- Cancer Control and Quality of Life (Composite)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven prostate adenocarcinoma * Gleason score 2-7 (reviewed by reference lab) * Biopsy within 6 months of date of registration 2. Clinical stage (CS) T1a-T2b, N0-Nx, M0-Mx (AJCC 6th Edition) * T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI) * M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases. 3. PSA less than or equal to 20 ng/ml 4. Patients belonging in one of the following risk groups: * Low: CS T1a-T2a and Gleason 2-6 and PSA less than or equal to 10, or * Intermediate: CS T2b and Gleason 2-6 and PSA less than or equal to 10, or CS T1b-T2b, and Gleason 2-6 and PSA less than or equal to 20 ng/ml, or Gleason 7 and PSA less than or equal to 10 ng/ml 5. Prostate volume less than or equal to 100 cc * Determined using: volume = π/6 x length x height x width * Measurement from CT or ultrasound less than or equal to 90 days prior to registration 6. Eastern Cooperative Oncology Group (ECOG performance status 0-1 7. No prior prostatectomy or cryotherapy of the prostate 8. No prior radiotherapy to the prostate or lower pelvis 9. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. 10. Completion of patient questionnaires. 11. Consent signed. 12. Intermediate risk patients may be treated with 4-6 months of hormonal therapy at the discretion of the treating physician.
References
Publications (0)
Data not yet available