N/A
Completed N=259
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Prostate Cancer · Prostatic Cancer · Cancer of the Prostate
Source: ClinicalTrials.gov NCT00643617 ↗
Enrolled (actual)
259
Serious AEs
16.2%
Results posted
May 2023
Primary outcomePrimary: Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity — 0; 0; 1.8; 0.7 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity |
0; 0; 1.8; 0.7; 0; 0 | — |
| PRIMARY Biochemical Disease-Free Survival (bDFS) |
100; 89.1; 100; 80 | — |
| SECONDARY Disease Control and Survival Outcomes |
100; 98.3; 100; 98.3; 100; 95 | — |
| SECONDARY Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) |
7.05; 7.12; 9.49; 8.64; 13.57; 14.14 | — |
| SECONDARY Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence |
95.77; 91.59; 90.33; 88.83; 92.81; 88.48 | — |
| SECONDARY Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive |
87.67; 87.59; 74.11; 74.03; 86.75; 82.91 | — |
| SECONDARY Quality of Life Assessments: EPIC-26 Bowel |
96.25; 94.84; 89.32; 86.05; 93.45; 89.92 | — |
| SECONDARY Quality of Life Assessments: EPIC-26 Sexual |
55.27; 56.32; 47.46; 50.58; 50.06; 51.23 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00643617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.