NCT01045148

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

14.8 years

First QC Date

January 6, 2010

Last Update Submit

July 18, 2017

Conditions

Prostate Cancer

Keywords

Prostatic CancerProstatic NeoplasmsProstate NeoplasmsCancer of the Prostate

Outcome Measures

Primary Outcomes (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.

    5 years

Study Arms (1)

CyberKnife Radiosurgery

OTHER

CyberKnife Radiosurgery

Radiation: CyberKnife Radiosurgery

Interventions

CyberKnife RadiosurgeryRADIATION

High Dose 3800 cGy/4 fractions

CyberKnife Radiosurgery

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CyberKnife Centers of San Diego

San Diego, California, 92024, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25819287DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Donald B Fuller, M.D.

    CyberKnife Centers of San Diego/Radiation Medical Group- Genesis Healthcare Partners

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlyn A Tripp

CONTACT

619-230-0400ctripp@genhp.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Donald Fuller, M.D.

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 8, 2010

Study Start

March 1, 2006

Primary Completion

December 1, 2020

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)