CyberKnife Radiosurgery for Localized Prostatic Carcinoma

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Prostate Cancer	Radiation: CyberKnife Radiosurgery	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	258 participants
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
Study Start Date :	March 2006
Estimated Primary Completion Date :	December 2020

Arms and Interventions

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Arm	Intervention/treatment
CyberKnife Radiosurgery; CyberKnife Radiosurgery	Radiation: CyberKnife Radiosurgery; High Dose 3800 cGy/4 fractions Radiation: CyberKnife Radiosurgery; Moderate Dose 3400 cGy/5 fractions

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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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

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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

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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
First Posted:	January 8, 2010
Last Update Posted:	July 21, 2017
Last Verified:	July 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