CyberKnife Radiosurgery for Localized Prostatic Carcinoma
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2014 by CyberKnife Centers of San Diego
Sponsor:
CyberKnife Centers of San Diego
Information provided by (Responsible Party):
Carlyn Tripp, CyberKnife Centers of San Diego
ClinicalTrials.gov Identifier:
NCT01045148
First received: January 6, 2010
Last updated: March 13, 2014
Last verified: March 2014
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: CyberKnife Radiosurgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
U.S. FDA Resources
Further study details as provided by CyberKnife Centers of San Diego:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 258 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CyberKnife Radiosurgery
CyberKnife Radiosurgery
|
Radiation: CyberKnife Radiosurgery
High Dose 3800 cGy/4 fractions
Radiation: CyberKnife Radiosurgery
Moderate Dose 3400 cGy/5 fractions
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045148
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045148
Contacts
| Contact: Carlyn A Tripp | 619-230-0400 ext 224 | ctripp@genhp.com |
Locations
| United States, California | |
| CyberKnife Centers of San Diego | Recruiting |
| San Diego, California, United States, 92024 | |
| Contact: Carlyn A Tripp 619-230-0400 ext 224 ctripp@genhp.com | |
| Principal Investigator: Donald B Fuller, M.D. | |
Sponsors and Collaborators
CyberKnife Centers of San Diego
Investigators
| Principal Investigator: | Donald B Fuller, M.D. | CyberKnife Centers of San Diego/Radiation Medical Group- Genesis Healthcare Partners |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Carlyn Tripp, Donald Fuller, M.D., CyberKnife Centers of San Diego |
| ClinicalTrials.gov Identifier: | NCT01045148 History of Changes |
| Other Study ID Numbers: |
Virtual HDR CK Radiosurgery |
| Study First Received: | January 6, 2010 |
| Last Updated: | March 13, 2014 |
Keywords provided by CyberKnife Centers of San Diego:
|
Prostatic Cancer Prostatic Neoplasms Prostate Neoplasms Cancer of the Prostate |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 25, 2017