Hypofractionated Stereotactic Body Radiation Therapy (SBRT)

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Radiation Treatment	Radiation Therapy	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)	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

Name	Time	Method
Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months	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.
Relation Between Dose Distribution and Toxicities.	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.
Relation Between Reconstructed Delivered Dose Distributions.	5 years	To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.
Frequency of Required Interventions.	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.

Locations (2): The Radiological Associates of Sacremento
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Sacramento, California, United States
University of Michigan Cancer Center
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Ann Arbor, Michigan, United States