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:
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
  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
Endpoint Classification: Efficacy Study
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:


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 ] [ Designated as safety issue: No ]

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
Genders 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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by CyberKnife Centers of San Diego:
Prostatic Cancer
Prostatic Neoplasms
Prostate Neoplasms
Cancer of the Prostate

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014