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NCT Number: NCT01985828

CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer

The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.

During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications.

The CyberKnife® system is a 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.

Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.

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Key information

Conditions

Prostate Adenocarcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

About this study

The purpose of this project is to evaluate the efficacy and Health-Related Quality of Life (HRQOL) in intermediate and high-risk prostate cancer patients treated with SBRT as monotherapy or as a boost in combination with IMRT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Patient must be ≥ 18 years of age.
  • Histologically proven prostate adenocarcinoma
  • Gleason score 2-10 (reviewed by reference lab)
  • Biopsy within one year of date of registration
  • Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition)
  • T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI; see section 4.5)
  • M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
  • PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment
  • Patients belonging in one of the following risk groups:
  • Intermediate: CS T2b-c and Gleason <6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7 and PSA ≤ 10 ng/ml, or Gleason <6 and PSA 11-20 ng/ml
  • High: CS T3-4, Gleason score >7and PSA<50
  • Prostate volume: ≤ 100 cc
  • Determined using: volume = π/6 x length x height x width
  • Measurement from MRI, CT or ultrasound prior to registration.
  • ECOG performance status 0-1
  • No prior prostatectomy or cryotherapy of the prostate
  • No prior radiotherapy to the prostate or lower pelvis
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  • No chemotherapy for a malignancy in the last 5 years.
  • No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.

Treatment and study plan

Cyberknife

Radiation

Androgen Deprivation Therapy (ADT)

Other

Intensity Modulated Radiation Therapy (IMRT)

Radiation

Per current standard of care

Primary outcomes

  1. Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions

    Time frame: 3 years

    Phoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir.

    Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir.

Secondary outcomes

  1. Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity

    Time frame: 3 years

    Acute toxicity is graded based upon Common Terminology Criteria for Adverse Events (CTCAE). The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is a standardized system used to classify and grade the severity of adverse events (AEs) experienced by cancer patients during treatment, with a grading scale ranging from 1 (mild) to 5 (death).

  2. Expanded Prostate Cancer Index Composite Epic-26

    Time frame: 3 years

    The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Nov 15, 2013
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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