Back to resultsHypofractionated Stereotactic Body Radiation Therapy (SBRT)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility 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
Sites / Locations
- The Radiological Associates of Sacremento
- University of Michigan Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation Treatment
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
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
Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months
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.
Relation Between Dose Distribution and Toxicities.
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.
Relation Between Reconstructed Delivered Dose Distributions.
To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.
Frequency of Required Interventions.
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.
Full Information
NCT ID
NCT01288534
First Posted
January 31, 2011
Last Updated
September 21, 2017
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Fox Chase Cancer Center, Cedars-Sinai Medical Center, Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01288534
Brief Title
Hypofractionated Stereotactic Body Radiation Therapy (SBRT)
Official Title
A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Fox Chase Cancer Center, Cedars-Sinai Medical Center, Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation Treatment
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months
Description
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.
Time Frame
1 Year
Title
Relation Between Dose Distribution and Toxicities.
Description
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.
Time Frame
5 years
Title
Relation Between Reconstructed Delivered Dose Distributions.
Description
To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.
Time Frame
5 years
Title
Frequency of Required Interventions.
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Spratt, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Radiological Associates of Sacremento
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hypofractionated Stereotactic Body Radiation Therapy (SBRT)
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