CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer

NCT02070952 | Unknown

• 1 other identifier: 1138830
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• CyberKnife Toxicities in Prostate Cancer

  The primary safety goal of this study is to estimate, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed following CyberKnife SABR for prostate cancer. The primary efficacy goal is to document the rate of biochemical Disease-Free Survival (bDFS) using the Phoenix and ASTRO definitions, at 5 years.

  5 years

Secondary Outcomes (1)

• Cancer Control and Quality of Life (Composite)

  5 years

Study Arms (1)

CyberKnife

EXPERIMENTAL

CyberKnife Stereotactic Ablative Body Radiation Therapy

Radiation: CyberKnife Stereotactic Ablative Body Radiation Therapy

Interventions

CyberKnife Stereotactic Ablative Body Radiation Therapy RADIATION

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.

Also known as: Accuray CyberKnife

CyberKnife

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven prostate adenocarcinoma
• Gleason score 2-7 (reviewed by reference lab)
• Biopsy within 6 months of date of registration
• 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.
• PSA less than or equal to 20 ng/ml
• 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
• 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
• Eastern Cooperative Oncology Group (ECOG performance status 0-1
• No prior prostatectomy or cryotherapy of the prostate

Sponsors & Collaborators

• Riverside Community Hospital, California: lead

Study Sites (1)

Riverside Community Hospital

Riverside, California, 92501, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Afshin Rashtian, MD

  Unaffilated

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda (Lori) A Arias, MBA

CONTACT

951-788-3115; Amanda.Arias@HCAHealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: February 25, 2014
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

US (1)