Trial record 9 of 43 for:    cyberknife | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Advocate Health Care
Sponsor:
Information provided by (Responsible Party):
Arica Hirsch, MD, Advocate Health Care
ClinicalTrials.gov Identifier:
NCT01985828
First received: April 12, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.

Patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or with prostate/seminal vesicles (SV)/pelvic Intensity Modulated Radiation Therapy (IMRT), followed by CyberKnife® SBRT boost. 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 month, 3 months and every 6 months for five years.


Condition Intervention
Prostate Adenocarcinoma
Radiation: CyberKnife
Other: Androgen Deprivation Therapy (ADT)
Radiation: Intensity Modulated radiation therapy (IMRT)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Advocate Health Care:

Primary Outcome Measures:
  • Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Measure local failure rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Measurement of local recurrence of prostate cancer

  • Measure distant failure rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Measurement of distant metastasis rate

  • Measure clinical disease-free survival rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Measure disease-specific survival rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Measure Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Quality of life (QOL) in generic and organ-specific domains [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: March 2014
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intermediate Risk

Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gray (7 Gray x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy

OR

Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)

Radiation: CyberKnife Other: Androgen Deprivation Therapy (ADT) Radiation: Intensity Modulated radiation therapy (IMRT)
Per current standard of care
Experimental: High Risk
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gray and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gray (7 Gray x 3) CyberKnife boost
Radiation: CyberKnife Other: Androgen Deprivation Therapy (ADT) Radiation: Intensity Modulated radiation therapy (IMRT)
Per current standard of care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be ≥ 18 years of age.
  • Histologically proven prostate adenocarcinoma
  • Biopsy within one year of date of registration
  • Clinical stage:
  • Intermediate Risk Group: T2b-c, Gleason ≤6, prostatic specific antigen (PSA) ≤ 10 ng/ml, OR T1b-T2a and Gleason 7, PSA ≤10 ng/ml, or Gleason ≤ 6, PSA 11-20 ng/ml
  • High Risk Group: T3-4 or Gleason >7 and PSA ≤ 50 ng/ml
  • 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). M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
  • Complete Blood Count (CBC), platelets, Blood Urea Nitrogen (BUN), creatinine, all within normal institutional limits
  • Prostate volume: ≤ 100 cc (Determined using: volume = π/6 x length x height x width. Measurement from CT or ultrasound ≤90 days prior to registration.)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

Exclusion Criteria:

  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy to the prostate or lower pelvis
  • Planted hardware or other material that would prohibit appropriate treatment planning or treatment delivery
  • Chemotherapy for a malignancy in the last 5 years
  • History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
  • Hormone ablation for two months prior to enrollment, or during treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985828

Contacts
Contact: Arica Hirsch, MD 847-723-8030

Locations
United States, Illinois
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Arica Hirsch, MD         
Principal Investigator: Arica Hirsch, MD         
Sponsors and Collaborators
Advocate Health Care
Investigators
Principal Investigator: Arica Hirsch, MD Advocate Lutheran General Hospital
  More Information

No publications provided

Responsible Party: Arica Hirsch, MD, Principal Investigator, Advocate Health Care
ClinicalTrials.gov Identifier: NCT01985828     History of Changes
Other Study ID Numbers: 5307
Study First Received: April 12, 2013
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Advocate Health Care:
Prostate neoplasm
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014