N/A
Completed N=35
High-Dose Stereotactic Radiation for Prostate Cancer
Prostate Cancer · Recurrent Prostate Cancer · Stage I Prostate Cancer · Stage IIA Prostate Cancer
Source: ClinicalTrials.gov NCT01664130 ↗
Enrolled (actual)
35
Serious AEs
2.9%
Results posted
Sep 2019
Primary outcomePrimary: Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 — 1 Participants
Summary
This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 |
1 | — |
| PRIMARY Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 |
— | — |
| SECONDARY Quality of Life as Assessed by EPIC Scores |
83.2; 83.4; 90.5; 86.3; 46.4; 37.1 | — |
| SECONDARY Quality of Life as Assessed by Change in AUA Scores |
8 | — |
| SECONDARY Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA |
96.5 | — |
Eligibility Criteria
Inclusion Criteria
- The patient must have prostate adenocarcinoma proven by histologic diagnosis
- The patient must have clinical stage T1a-T3b with localized prostate cancer considered low, intermediate, or high risk as defined by the National Comprehensive Cancer Network (NCCN) guidelines; any patient whom is defined as high-risk must undergo screening with computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis as well as bone scan prior to enrollment for staging purposes; low and intermediate risk patients do not require imaging for staging unless they have a focal symptom warranting investigation
- Performance status - Karnofsky performance status (PS) >= 70
- Life expectancy of > 5 years, in the opinion of and as documented by the investigator
- Patients must either already have fiducials already placed within the prostate, or otherwise be candidates for prostate fiducial placement (no bleeding disorders which may cause excessive bleeding with fiducial placement, INR 350 lbs
- Contraindications to placement of fiducials required for high-precision image guidance (e.g. bleeding disorders which may cause excessive bleeding with placement, requirement for coumadin, international normalized ratio [INR] > 2.0)
- Patients unable to maintain a full bladder during treatment
- Previous prostatectomy
- Inflammatory bowel disease
- AUA score > 15 in spite of optimal therapy
Data sourced from ClinicalTrials.gov (NCT01664130). 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.