N/A
N=310
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Prostate Cancer · Prostatic Cancer · Prostate Neoplasms · Prostatic Neoplasms · Cancer of the Prostate
Bottom Line
View on ClinicalTrials.gov: NCT00643994 ↗Enrolled (actual)
310
Serious AEs
11.0%
Results posted
May 2023
Primary outcome: Primary: Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity — 0; 0; 0; 1.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CyberKnife Stereotactic Radiosurgery (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Accuray Incorporated
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity |
0; 0; 0; 1.5; 0; 1.5 | — |
| PRIMARY Biochemical Disease-Free Survival (bDFS) |
97.3; 91.7 | — |
| SECONDARY Disease Control and Survival Outcomes |
99.7; 96.4; 99.3; 98.6; 97.3; 90.1 | — |
| SECONDARY Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI) |
7.58; 12.53; 14.13; 11.64; 7.53; 7.20 | — |
| SECONDARY Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence |
94.03; 89.30; 92.08; 88.49; 89.03; 89.23 | — |
| SECONDARY Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive |
87.85; 75.20; 87.82; 84.29; 87.43; 89.64 | — |
| SECONDARY Quality of Life Assessments: EPIC-26 Bowel |
94.88; 83.47; 91.61; 90.12; 92.18; 92.88 | — |
| SECONDARY Quality of Life Assessments: EPIC-26 Sexual |
56.79; 53.74; 53.74; 50.19; 47.71; 47.31 | — |
Summary
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00643994). 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.