Hypofractionated Stereotactic Body Radiation Therapy (SBRT)
This study is currently recruiting participants.
Verified May 2013 by University of Michigan Cancer Center
Sponsor:
University of Michigan Cancer Center
Collaborators:
Fox Chase Cancer Center
Cedars-Sinai Medical Center
Washington University School of Medicine
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01288534
First received: January 31, 2011
Last updated: May 11, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: Radiation Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion |
Resource links provided by NLM:
Further study details as provided by University of Michigan Cancer Center:
Primary Outcome Measures:
- Evaluate the safety of the proposed hyperfractionation regimen [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- To evaluate clinical outcomes including clinical recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]To evaluate clinical outcomes including clinical recurrence (local or metastatic), and prostate cancer specific survival as well as 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.
- To look at the relation between dose distribution and toxicities. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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.
- To determine the relation between reconstructed delivered dose distributions. [ Time Frame: 5 years ] [ Designated as safety issue: No ]To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.
- To assess the frequency of required interventions. [ Time Frame: 5 years ] [ Designated as safety issue: No ]To assess the frequency of required interventions 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.
| Estimated Enrollment: | 66 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288534
Contacts
| Contact: Cancer Answer Line | 1-800-865-1125 | canceranswerline@umich.edu |
Locations
| United States, California | |
| The Radiological Associates of Sacremento | Recruiting |
| Sacremento, California, United States, 95815 | |
| Contact: Garrick Chang, M.D. (916) 537-5470 | |
| Contact: Seth Rosenthal, M.D., F.A.C.R (916) 781-1225 | |
| United States, Michigan | |
| University of Michigan Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States | |
| Contact: Daniel Hamstra, Ph.D., MD 734-936-4300 dhamm@med.umich.edu | |
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 Hamstra, Ph.D., MD | University of Michigan Cancer Center |
More Information
No publications provided
| Responsible Party: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01288534 History of Changes |
| Other Study ID Numbers: | 2010.064, HUM00041474 |
| Study First Received: | January 31, 2011 |
| Last Updated: | May 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013