CyberKnife Radiosurgery for Localized Prostatic Carcinoma

This study is currently recruiting participants.

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Contacts and Locations

Verified July 2017 by Carlyn Tripp, CyberKnife Centers of San Diego

Sponsor:

Information provided by (Responsible Party):

Carlyn Tripp, CyberKnife Centers of San Diego

ClinicalTrials.gov Identifier:

NCT01045148

First received: January 6, 2010

Last updated: July 18, 2017

Last verified: July 2017

History of Changes

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:	Intervention Model: Single Group Assignment Masking: None (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 Carlyn Tripp, 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

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):

De Bari B, Daidone A, Alongi F. Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. Crit Rev Oncol Hematol. 2015 Jun;94(3):360-70. doi: 10.1016/j.critrevonc.2015.02.003. Epub 2015 Feb 17. Review.


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:	July 18, 2017

Keywords provided by Carlyn Tripp, 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 September 21, 2017

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