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Hypofractionated Stereotactic Body Radiation Therapy (SBRT)

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ClinicalTrials.gov Identifier: NCT01288534
Recruitment Status : Completed
First Posted : February 2, 2011
Results First Posted : June 9, 2016
Last Update Posted : October 24, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to evaluate the safety and tolerability of using radiation therapy with 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso).A number of recent studies have used 5 radiation fraction to treat prostate cancer over 2-3 weeks as compared to the typical treatment which would involve 40-42 smaller radiation fractions over 8-9 weeks. This type of radiation using a smaller number of treatments has been called hypofractionated radiation therapy.

The Calypso is a new technique which uses beacons implanted into the prostate which using radio signals are able to localize and track the position of the prostate continuously during radiation therapy. The Calypso system has been approved by the United States Food and Drug Administration (FDA) for guidance of radiation therapy during the treatment of prostate cancer and is being utilized all across the United States. However, it has not been tested for hypofractionated radiation therapy.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiation Therapy Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion
Study Start Date : January 2011
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Radiation Treatment Radiation: Radiation Therapy
Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL) [ Time Frame: 24 months ]

    To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks.

    Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months.



Secondary Outcome Measures :
  1. Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months [ Time Frame: 1 Year ]
    To estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion.

  2. Relation Between Dose Distribution and Toxicities. [ Time Frame: 5 years ]
    To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses.

  3. Relation Between Reconstructed Delivered Dose Distributions. [ Time Frame: 5 years ]
    To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.

  4. Frequency of Required Interventions. [ Time Frame: 5 years ]
    To assess the frequency of required interventions (interruptions) based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical. This will be assessed by the percentage of patients with no interventions for any fraction, the percentage of patients with 1-2 fractions interrupted and the percentage of patients with more than two fractions interrupted and the percentage of patients that had an interruption of the beam at least once for all 5 fractions.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of enrollment
  • Signed informed consent
  • Gleason score ≤ 7
  • If Gleason 7 (3+4=7 or 4+3=7) then <50% of biopsy cores must be positive for any pathologic grade of prostate cancer
  • If Gleason score <7 then there is no limit on the percentage of biopsy cores involved by prostate cancer
  • PSA (within 90 days prior to enrollment)
  • ≤ 15 ng/ml prior to start of therapy if Gleason ≤ 6 and
  • ≤ 10 ng/ml prior to start of therapy if Gleason 7
  • No plan to use hormone therapy prior to evidence of biochemical failure(ie: No neoadjuvant or adjuvant ADT)
  • Tumor stage: T1a, T1b, T1c, T2a, T2b
  • ECOG Performance Status 0-1

Exclusion Criteria:

  • A history of other malignancy diagnosed within the previous 60 months except for non-melanoma skin cancer.
  • Any patients who have received other investigational therapy within the last 60 days
  • Individuals that have previously been implanted with permanent Beacon transponders
  • Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip)
  • Patients with implanted pacemaker or defibrillators
  • Patients who are felt to have body habitus not conducive to tracking with Calypso beacons
  • Positive lymph nodes or metastatic disease from prostate cancer
  • Tumor stage: T2c, T3, or T4
  • Previous pelvic radiation therapy
  • Previous surgery or chemotherapy for prostate cancer
  • Previous transuretheral resection of the prostate (TURP) or cryotherapy to the prostate
  • Prior hormone therapy or plans for concurrent or post treatment adjuvant hormonal therapy or chemotherapy
  • Hormone therapy to include LHRH agonist or oral anti-androgen
  • Finasteride and Dutasteride use not excluded
  • Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiation therapy, and chemotherapy) while on this protocol
  • History of Crohn's Disease or Ulcerative Colitis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288534


Locations
United States, California
The Radiological Associates of Sacremento
Sacramento, California, United States, 95815
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Sponsors and Collaborators
University of Michigan Cancer Center
Fox Chase Cancer Center
Cedars-Sinai Medical Center
Washington University School of Medicine
Investigators
Principal Investigator: Daniel Spratt, MD University of Michigan Cancer Center
More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01288534     History of Changes
Other Study ID Numbers: 2010.064
HUM00041474 ( Other Identifier: University of Michigan Medical School IRB )
First Posted: February 2, 2011    Key Record Dates
Results First Posted: June 9, 2016
Last Update Posted: October 24, 2017
Last Verified: September 2017