Description:
Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and
efficacy compared with actual prostate HDR treatment, but does it without the catheters and
hospital admission. As such, it is a more "patient friendly" treatment method compared with
actual prostate HDR brachytherapy as currently practiced. Related, as has previously been
reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should
have a high efficacy but with lower acute and chronic morbidity compared with other local
prostate cancer treatment methods such as permanent seed prostate brachytherapy.
Title
- Brief Title: CyberKnife Radiosurgery for Localized Prostatic Carcinoma
- Official Title: Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study
Clinical Trial IDs
- ORG STUDY ID:
Virtual HDR CK Radiosurgery
- NCT ID:
NCT01045148
Conditions
Purpose
Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and
efficacy compared with actual prostate HDR treatment, but does it without the catheters and
hospital admission. As such, it is a more "patient friendly" treatment method compared with
actual prostate HDR brachytherapy as currently practiced. Related, as has previously been
reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should
have a high efficacy but with lower acute and chronic morbidity compared with other local
prostate cancer treatment methods such as permanent seed prostate brachytherapy.
Detailed Description
Brachytherapy is a form of treatment where a radioactive isotope is implanted directly into a
tumor volume to deliver a lethal dose of radiation. High Dose Rate (HDR) Prostate
brachytherapy is a particularly elegant brachytherapy dose sculpting method that is
effectively used in the curative treatment of prostate cancer; however, it requires hospital
admission and many temporarily implanted transperineal catheters to deliver the radiation
source to the target volume, resulting in significant patient discomfort. CyberKnife delivers
a form of radiation treatment that is so precise, it appears capable of reconstructing HDR
prostate radiation dose sculpting, without the hospital admission and without the catheters.
The CyberKnife device is also used for classic radiosurgery, with accuracy comparable to the
Gamma Knife, but unlike the Gamma Knife, has the capability to target lesions anywhere in the
body with similar accuracy. The aim of this study is to compare CyberKnife morbidity and
efficacy with that of HDR and other local treatment methods such a permanent seed prostate
brachytherapy in the treatment of prostate cancer.
Trial Arms
Name | Type | Description | Interventions |
---|
CyberKnife Radiosurgery | Other | CyberKnife Radiosurgery | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b
(AJCC 6th Edition, see Appendix II), NX/N0, M0.
- Karnofsky performance status > 80.
- Patient must be ≥ 18 years of age.
- Gleason Sum < or = 7
- Prostate-specific antigen < or = 20 ng/ml
- Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria:
- Stage < T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).
- Gleason Score > 7.
- PSA > 20 ng/ml.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical
clips or other metallic foreign bodies.
- History of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three
months prior to treatment).
- Previous or concurrent cancers other than basal, in situ, or squamous cell skin
cancers unless disease-free for ≥ 5 years.
- Major medical or psychiatric illness, which in the investigator's opinion, would
prevent completion of treatment and would interfere with follow-up.
- Metallic Hip prosthesis.
- History of inflammatory bowel disease
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | Accepts Healthy Volunteers |
Primary Outcome Measures
Measure: | To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter. |
Time Frame: | 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | CyberKnife Centers of San Diego |
Trial Keywords
- Prostatic Cancer
- Prostatic Neoplasms
- Prostate Neoplasms
- Cancer of the Prostate
Last Updated
July 21, 2017