Clinical trial · Interventional
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
NCT00643617CI-TRIAL-00066288completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.
Conditions
Conditions (5)
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 Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Prostatic Cancer | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery - Intermediate Risk | Radiation | — | UNRESOLVED |
| CyberKnife Stereotactic Radiosurgery - Low Risk | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Heterogeneous Dose
- description
- 38 Gy delivered in 4 fractions of 9.5 Gy per fraction
- interventionNames
- Radiation: CyberKnife Stereotactic Radiosurgery - Low Risk
- Radiation: CyberKnife Stereotactic Radiosurgery - Intermediate Risk
Primary outcomes (2)
- measure
- Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
- timeFrame
- Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
- description
- To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed in both low-risk and intermediate-risk cohorts 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must be at least 18 years of age * Histologically proven prostate adenocarcinoma * Biopsy within 1 year of date of registration * Clinical Stage (CS) T1b-T2b, N0, M0 * Patients belonging to one of the following risk categories: * Low Risk: CS T1b-T2a, Gleason Score 2-6, Prostate Specific Antigen (PSA) \< or = 10 ng/ml * Intermediate Risk: CS T2b, Gleason Score 2-6, PSA \< or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA \< or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA \< or = 10 ng/ml * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Exclusion Criteria: * Clinical Stage T2c or greater * Prior prostatectomy or cryotherapy of the prostate * Prior radiotherapy of the prostate or lower pelvis * Implanted hardware or other material that would prohibit appropriate treatment planning or delivery * History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years * Hormone ablation for two months prior to enrollment or during treatment
References
Publications (0)
Data not yet available
No reference posted for this study.