Clinical trial · Interventional
A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution
- 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 effects of CyberKnife radiosurgery in patients with early stage prostate cancer. The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CyberKnife Radiosurgery
- interventionNames
- Radiation: CyberKnife Radiosurgery
Primary outcomes (1)
- measure
- Local control rate
- timeFrame
- 5-10 years
- description
- * To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival \[bDFS\], Phoenix and ASTRO definitions, at 5 and 10 years). * To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer.
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5-10 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Male Age ≥ 21 * Histologically proven prostate adenocarcinoma * Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition) * PSA ≤ 20 ng/ml * Prostate volume ≤ 100 cc Patients belonging in one of the following risk groups: * Low: * CS T1b-T2a and Gleason 2-6 and PSA ≤ 10 * 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 Exclusion Criteria: * Any histology other than adenocarcinoma * Age \< 21 * KPS \<= 40 \<70 * ECOG Performance Status ≥ 2 * Patient weight \>350 lbs. (table limitation) * Prior XRT to prostate or lower pelvis * Prior surgery or cryotherapy to prostate * 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 2 months prior to enrollment, or during treatment
References
Publications (0)
Data not yet available