Back to results

CyberKnife Radiosurgery for Localized Prostatic Carcinoma

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CyberKnife Radiosurgery

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

CyberKnife Centers of San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CyberKnife Radiosurgery

Arm Description

CyberKnife Radiosurgery

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01045148

First Posted

January 6, 2010

Last Updated

July 18, 2017

Sponsor

CyberKnife Centers of San Diego

1. Study Identification

Unique Protocol Identification Number

NCT01045148

Brief Title

CyberKnife Radiosurgery for Localized Prostatic Carcinoma

Official Title

Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

CyberKnife Centers of San Diego

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CyberKnife Radiosurgery

Arm Type

Other

Arm Description

CyberKnife Radiosurgery

Intervention Type

Radiation

Intervention Name(s)

CyberKnife Radiosurgery

Intervention Description

High Dose 3800 cGy/4 fractions

Intervention Type

Radiation

Intervention Name(s)

CyberKnife Radiosurgery

Intervention Description

Moderate Dose 3400 cGy/5 fractions

Primary Outcome Measure Information:

Title

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carlyn A Tripp

Phone

619-230-0400

Ext

224

ctripp@genhp.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald B Fuller, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

CyberKnife Centers of San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92024

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlyn A Tripp

Phone

619-230-0400

Ext

224

ctripp@genhp.com

First Name & Middle Initial & Last Name & Degree

Donald B Fuller, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

25819287

Citation

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.

Results Reference

derived

Learn more about this trial

CyberKnife Radiosurgery for Localized Prostatic Carcinoma

We'll reach out to this number within 24 hrs