Hypofractionated Stereotactic Body Radiation Therapy (SBRT)

A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Radiation Therapy

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • The Radiological Associates of Sacremento
  • Michigan
    • Ann Arbor, Michigan, United States
      • University of Michigan Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Year
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.	5 years
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.	5 years
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.	5 years

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Fox Chase Cancer Center; Washington University School of Medicine; Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Daniel Spratt, MD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 1, 2011
• First Posted (Estimate): February 2, 2011

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2010.064; HUM00041474 (Other Identifier: University of Michigan Medical School IRB)