Recruiting

CyberKnife

Sponsor:

Riverside Community Hospital, California

Code:

NCT02070952

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CyberKnife Stereotactic Ablative Body Radiation Therapy

Study Details

Brief summary:

The purpose of this study is to determine the side effects and how effective CyberKnife stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with low to intermediate risk prostate cancer and to evaluate the effect of this treatment on the patients' quality of life over time.

Conditions

Prostate Cancer

Study ID

NCT02070952

Start date

Jul, 2013

Status verified date

Feb, 2014

Completion date

Jul, 2018

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologically proven prostate adenocarcinoma

  • Gleason score 2-7 (reviewed by reference lab)
  • Biopsy within 6 months of date of registration
2. Clinical stage (CS) T1a-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)

  • T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
  • M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
3. PSA less than or equal to 20 ng/ml
4. Patients belonging in one of the following risk groups:

  • Low: CS T1a-T2a and Gleason 2-6 and PSA less than or equal to 10, or
  • Intermediate: CS T2b and Gleason 2-6 and PSA less than or equal to 10, or CS T1b-T2b, and Gleason 2-6 and PSA less than or equal to 20 ng/ml, or Gleason 7 and PSA less than or equal to 10 ng/ml
5. Prostate volume less than or equal to 100 cc

  • Determined using: volume = π/6 x length x height x width
  • Measurement from CT or ultrasound less than or equal to 90 days prior to registration
6. Eastern Cooperative Oncology Group (ECOG performance status 0-1
7. No prior prostatectomy or cryotherapy of the prostate
8. No prior radiotherapy to the prostate or lower pelvis
9. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
10. Completion of patient questionnaires.
11. Consent signed.
12. Intermediate risk patients may be treated with 4-6 months of hormonal therapy at the discretion of the treating physician.

Study Design

Enrollment

167 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CyberKnife

CyberKnife Stereotactic Ablative Body Radiation Therapy

Interventions

CyberKnife Stereotactic Ablative Body Radiation Therapy

The prescribed planned tumor volume (PTV) dose of 36.25 Gy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland.

Primary outcome measure

  • CyberKnife Toxicities in Prostate Cancer [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Riverside Community Hospital

Recruiting

Riverside, California, United States, 92501

Contacts

Principal Investigator:

Afshin Rashtian, MD

More Information

Sponsor

Riverside Community Hospital, California

Last update posted

Feb 25, 2014

Last verified

Feb, 2014

Keywords

  • CyberKnife
  • Stereotactic Body Radiation Therapy
  • Low and Intermediate Risk Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Riverside Community Hospital, California on 2014-02-25.