A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day
Phase: NA
Conditions: Prostate Cancer
Sponsor: Duke University

Duke Prostate SBRT 
1 
 
 
 
A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using 
Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization 
based on Same Day Anatomy 
 
 
 
 
Principal Investigators 
 
Radiation Oncology 
W. Robert Lee, MD, MS, M. Ed. 
Department of Radiation Oncology 
Duke University 
DUMC Box 3085 
Durham, NC 27710 
919-668-7342 
FAX: 919-668-7345 
w.robert.lee@mc.duke.edu 
 
Physics 
Q. Jackie Wu, Ph.D. 
Department of Radiation Oncology 
Duke University 
DUMC Box 3295 
Durham, NC 27710 
919-681-1841 
FAX: 919-681-7183 
Jackie.wu@duke.edu 
 
 
Version Date: June 17, 2013 
 
NCT00941915 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
2 
 
 
 
SCHEMA 
Gleason Score 
1. ≤6 
2. 7 
Register on Study 
Treatment Arm 
PSA 
1. ≤ 15 ng/mL if Gleason ≤6 
2. ≤ 10 ng/mL if Gleason 7 
7.4 Gy for 5 fractions 
delivered every other day; 
IMRT/IGRT with 
reoptimization for each 
fraction 
T stage 
T1-2 
 
 
 
Treatment is prescribed as a minimum to the planning target volume (PTV) to be delivered at a 
daily dose of 7.4 Gy/ fraction. The PTV includes with CTV (prostate only) with a nonuniform 
margin. 
 
Patient Population: (See Section 3.0 for Eligibility) 
- Histologically confirmed prostate adenocarcinoma within 365 days prior to registration 
- Clinical stage T1-2 according to the AJCC 6th edition 
- Pretreatment PSA ≤10 ng/mL if Gleason 7 or ≤ 15 ng/ml if Gleason ≤6 (within 180 days of 
registration) 
- Gleason score must be ≤7 
- No previous radical surgery or cryosurgery for prostate cancer 
- No prior or planned androgen deprivation or bilateral orchiectomy 
 
 
 
Required Sample Size: 60

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
3 
 
 Table of Contents 
SCHEMA ............................................................................................................................ 2 
1.0 
Introduction ............................................................................................................. 5 
1.1 
Conventionally Fractionated External Beam Radiotherapy ............................................... 5 
1.2 
Biologic Basis of Hypofractionation .................................................................................. 5 
1.3 
Hypofractionation in Prostate Cancer ................................................................................ 6 
2.0 
Objectives ............................................................................................................... 6 
2.1 
Primary Objective .............................................................................................................. 6 
2.2 
Secondary Objectives ......................................................................................................... 7 
2.3 
Duration of Investigation and Expected Enrollment Rate .................................................. 7 
3.0 
Study Design and Patient Selection ........................................................................ 7 
3.1 
Study Design ...................................................................................................................... 7 
3.2 
Inclusion Criteria ............................................................................................................... 7 
3.3 
Exclusion Criteria .............................................................................................................. 7 
4.0 
Pretreatment Evaluations ........................................................................................ 8 
4.1 
Symptom Assessment and QOL Evaluation ...................................................................... 8 
4.2 
Insurance Pre-Authorization .............................................................................................. 9 
5.0 
Radiation Therapy ................................................................................................... 9 
5.1 
Dose Specifications ............................................................................................................ 9 
5.2 
Supportive Measures .......................................................................................................... 9 
5.3 
Technical Factors ............................................................................................................... 9 
5.4 
Set-up, Localization and Tracking ..................................................................................... 9 
5.5 
Treatment Planning .......................................................................................................... 10 
5.6 
Critical Structures ............................................................................................................ 11 
5.7 
Image/signal-guidance for target localization .................................................................. 12 
5.8 
Radiation Toxicity............................................................................................................ 13 
5.9 
Radiation Adverse Event Reporting ................................................................................. 13 
6.0 
Study Visits ........................................................................................................... 15 
6.1 
Study Presentation............................................................................................................ 15 
6.2 
Treatment Planning .......................................................................................................... 15 
6.3 
SBRT ............................................................................................................................... 15 
6.4 
Treatment Checks ............................................................................................................ 15 
6.5 
Follow-up Visits ............................................................................................................... 16 
6.6 
Patient Assessments ......................................................................................................... 16 
6.7 
Data Collection ................................................................................................................ 16 
6.8 
Adverse Events Classification .......................................................................................... 17 
7.0 
Statistical Analysis Plan ........................................................................................ 17 
7.1 
Primary End Point ............................................................................................................ 17 
7.2 
Secondary End-Points ...................................................................................................... 17 
7.3 
Sample Size and Patient Accrual ..................................................................................... 18 
7.4 
Stopping Rules for Excessive Adverse Events................................................................. 18 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
4 
 
8.0 
References ............................................................................................................. 19 
9.0 
Appendices ............................................................................................................ 19 
9.1 
Appendix 1 AJCC Staging System – Prostate, 6th Edition ............................................... 20 
9.2 
Appendix 2   EPIC-26 ...................................................................................................... 22 
9.3 
Appendix 3     Data Collection: Dosimetry and Initial Evaluation................................... 26 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
5 
 
 
1.0 
Introduction 
1.1 
Conventionally Fractionated External Beam Radiotherapy 
The optimal radiation schedule taking into account both daily fraction size and overall 
duration of treatment for the curative treatment of prostate cancer using external beam 
radiation therapy (EBRT) is unknown.  Over the last 10 years it has been typical for most 
patients to receive daily fractions of 1.8-2.0 Gy for a duration of 7-8 weeks to a total 
cumulative dose to the prostate of 70-79 Gy (1).  Treatment in this fashion has been 
demonstrated to be safe with moderate rates of late rectal and bladder toxicity.  
 
Four randomized trials provide evidence that doses above 74 Gy can increase the 
likelihood of cure but higher doses are associated with increased toxicity, especially rectal 
toxicity (2-5). In the MD Anderson randomized trial there was an increase in grade 2 or 
higher rectal toxicity from 12% to 26% between the 70 Gy and 78 Gy arms (6).  In further 
analysis of this study it was found that both the volume of rectum treated to higher doses 
(70 Gy) as well as lower doses (40-60 Gy) contributed to late rectal toxicity (7).   
Further dose intensification using conventional fractions of 1.8-2.0 Gy is not likely to 
provide significant further gains without coincident increases in late toxicity because the 
anterior rectal wall and prostate are in close physical proximity.  Even with the most 
successful radiation targeting one will not be able to adequately treat the prostate without 
also treating a portion of the anterior rectal wall.  Additionally, the delivery of radiation 
therapy over this protracted period of time is expensive and inconvenient for patients with 
some radiation schedules in excess of 9 weeks.   
We propose to investigate a novel treatment regimen that will: 1) significantly reduce the 
duration of treatment and 2) limit the volume of normal tissue radiated while maintaining 
equivalent efficacy. In short, we hypothesize that hypofractionated radiation therapy using 
continuous real-time evaluation of prostate motion combined with reoptimization of the 
IMRT plan according to the anatomy of the day will improve the therapeutic ratio. 
 
1.2 
Biologic Basis of Hypofractionation   
The efficacy of radiation in causing reproductive cellular death is a function of the overall 
radiation dose, the dose per fraction, and the overall treatment time. Classically this 
relationship is described according to the linear-quadratic (LQ) model. Using the LQ 
model the fractionation sensitivity of both tumor cells and normal tissues can be defined 
using the alpha-beta ratio (α/ß).   
 
Rapidly dividing tumors or acute responding normal tissues are generally described by a 
high alpha-beta ratio (≥ 10 Gy) such that changes in individual fraction size would be 
expected to only have a modest overall impact on efficacy as compared to overall 
treatment dose.  In contrast, slowly dividing tissues that exhibit late toxicity to radiation 
therapy (such as bone, connective tissues, or spinal cord) are often described by a lower 
alpha-beta ratio (in the range of 3-5 Gy) such that larger daily fractions would be 
anticipated to cause relatively greater toxicity when compared to smaller fractions when 
delivered to the same total dose. In most clinical scenarios cancers have alpha-beta ratios 
much higher than the normal tissues adjacent to them (i.e. 10 Gy vs. 3 Gy) and as a result 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
6 
 
conventional radiation fractions of 1.8-2.0 Gy have the greatest likelihood of maintaining 
an advantageous therapeutic ratio as radiation doses are escalated. 
There is accumulating evidence that prostate cancer may have a lower alpha-beta ratio than 
nearby normal tissues (rectum, bladder) (8).  This observation has encouraged investigators 
to evaluate radiation fractionation schemes that use fraction sizes larger than 1.8-2.0 Gy 
(9). If the alpha-beta ratio of prostate cancer is lower than nearby normal tissues then 
treating prostate cancer with fewer, larger fractions (to a lower total dose) should result in 
an increase in the therapeutic ratio.   
 
1.3 
Hypofractionation in Prostate Cancer 
In the last decade investigators from across the globe have examined a number of 
hypofractionated regimens with daily fraction sizes ranging from 2.5 to 7.25 Gy delivered 
in 5-28 fractions over 1-6 weeks (10).  As this protocol examines a five fraction regimen, 
only the experience with five fraction regimens will be reviewed. 
Investigators at the Virginia Mason Clinic in Seattle published the first experience with a 
five fraction regimen in 2006 (11). These clinicians treated a total of 40 patients with low 
risk prostate cancer (T2a or less, Gleason 6 or less, PSA 10.0 or less) and reported 
preliminary toxicity and efficacy results with a median follow-up of 41 months.  The 
Virginia Mason clinicians delivered five fractions of 6.7 Gy (total dose 33.5 Gy) over five 
days.  
 
The 5 year estimate of freedom from biochemical recurrence is 90% by RTOG-Phoenix 
definition.  Late toxicity was defined as occurring 30 or more days after the completion of 
therapy.  Overall, the treatment was well tolerated with no Grade 3-5 genitourinary (GU) or 
gastrointestinal (GI) toxicity reported at a median of 41 months of follow-up. Grade 2 
genitourinary toxicity was reported in 20% (8/40) of patients and Grade 2 gastrointestinal 
toxicity was reported in 7.5% (3/40) of patients. 
The second published experience with a five fraction regimen comes from investigators at 
Stanford University (12).  These clinicians treated a total of 41 patients with low risk 
prostate cancer (T2a or less, Gleason 6 or less, PSA 10.0 or less) and reported preliminary 
toxicity and efficacy results with a minimum follow-up of 6 months (median 33 months).  
The Stanford regimen delivered 5 fractions of 7.25 Gy over 1-2 weeks.  
 
The Stanford investigators reported no RTOG Grade 4-5 acute or late GU/GI 
complications. Two patients experienced RTOG Grade 3 late GU toxicity and none 
reported Grade 3 GI complications. A reduced rate of rectal toxicities was observed with 
every-other-day vs. 5 consecutive days treatment regimen (0% vs. 38%, p = 0.0035). At 
last follow-up, no patient has had a biochemical recurrence. Of 32 patients with 12 months 
minimum follow-up, 25 patients (78%) achieved a PSA nadir ≤0.4 ng/mL. A PSA decline 
to progressively lower nadirs up to 3 years after treatment was observed. 
  
2.0 
Objectives 
2.1 
Primary Objective 
To evaluate the incidence of GU and GI acute and late toxicity (see Section 8.1) for 
patients treated with prostate stereotactic body radiotherapy (SBRT) along with prostate 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
7 
 
localization (Calypso or ExacTrac and onboard cone-beam CT) and IMRT reoptimization 
for each fraction based on the anatomy of the day. 
 
2.2 
Secondary Objectives 
2.2.1 
Disease-free survival: Disease-free failure events include local progression, 
distant progression, biochemical failure as defined by the RTOG Phoenix 
definition, and death from any cause.  
2.2.2 
Evaluate patient quality of life (QOL) using the Expanded Prostate Cancer Index 
Composite 26 (EPIC-26) for evaluation of the QOL for up to 3 years after the 
completion of SBRT. 
 
2.3 
Duration of Investigation and Expected Enrollment Rate 
Men will be enrolled on study after meeting eligibility criteria and signing consent. Follow-
up will continue for each enrollee up to three years after enrollment. It is estimated that a 
subject will be involved in the study for 36 months.  We anticipate that this study will 
begin enrolling subjects in the Fall 2009 and will enroll 2 subjects a month for 30 months 
for a total enrollment of 60. 
 
3.0 
Study Design and Patient Selection  
3.1 
Study Design 
This is a Phase II single institution investigator-initiated trial where the primary end-point 
is the assessment of Grade 2+ late toxicity 2 years from the start of treatment.  Based upon 
an assumed linear rate of grade 2 or greater toxicity from 18 – 36 months after the 
completion of treatment the primary end-point will be assessed when all patients have 
completed treatment,  have a minimum of 3 months of follow-up, and a cumulative 120 
person/years of follow-up have been recorded (an average of 2 years per patient). 
 
3.2 
Inclusion Criteria   
3.2.1 
Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 
days of study enrollment 
3.2.2 
History/physical examination with digital rectal examination of the prostate 
within 8 weeks prior to study enrollment 
3.2.3 
Gleason score ≤7 
3.2.4 
Clinical Stage T1-T2c 
3.2.5 
PSA   
 
≤ 15 ng/ml prior to start of therapy if Gleason ≤6  
OR  
 
≤ 10 ng/ml prior to start of therapy if Gleason 7  
3.2.6 
ECOG/Zubrod Performance Status 0-1 
3.2.7 
Age > 40 
3.2.8 
Patient signs study specific informed consent prior to study enrollment.  
 
3.3 
Exclusion Criteria 
3.3.1 
Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) 
or lymphomatous/hematogenous malignancy unless continually disease free for a 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
8 
 
minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity 
is permissible) 
3.3.2 
Evidence of distant metastases (based on disease stage and clinical presentation) 
3.3.3 
Evidence of regional lymph node involvement (based on disease stage and 
clinical presentation) 
3.3.4 
Significant urinary obstruction (i.e. AUA Symptom score > 18) 
3.3.5 
Estimated prostate gland > 100 grams (within 8 weeks prior to study enrollment) 
3.3.6 
Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer 
3.3.7 
Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy 
3.3.8 
Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), 
anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical 
castration (bilateral orchiectomy) or planned concurrent androgen deprivation 
therapy 
3.3.9 
Previous or concurrent cytotoxic chemotherapy for prostate cancer 
3.3.10 
Prosthetic implants in the pelvic region that contain metal or conductive materials 
(e.g., an artificial hip). 
3.3.11 
Severe, active comorbidity, defined as follows: 
• 
Unstable angina and/or congestive heart failure requiring hospitalization within 
the last 6 months 
• 
Transmural myocardial infarction within the last 6 months 
• 
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of 
registration 
• 
Crohn’s Disease or ulcerative colitis 
• 
Chronic obstructive pulmonary disease exacerbation or other respiratory illness 
requiring hospitalization or precluding study therapy at the time of registration 
• 
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; 
note, however, that laboratory tests for liver function and coagulation parameters 
are not required for entry into this protocol. (Patients on Coumadin or other blood 
thinning agents are eligible for this study.) 
• 
Acquired immune deficiency syndrome (AIDS) based upon current CDC 
definition; note, however, that HIV testing is not required for entry into this 
protocol. The need to exclude patients with AIDS from this protocol is necessary 
because the treatments involved in this protocol may be significantly 
immunosuppressive. Protocol-specific requirements may also exclude 
immunocompromised patients. 
 
4.0 
Pretreatment Evaluations   
Note: This section lists baseline evaluations needed before the initiation of protocol treatment 
that do not affect eligibility. 
4.1 
Symptom Assessment and QOL Evaluation  
(These may be performed prior to consent as they are routine for urology or radiation 
oncology clinics); 
4.1.1 
International Prostate Symptom Score (IPSS)/American Urological Association 
Symptom Score, International Index of Erectile Function (IIEF-5) and EPIC-26 
QOL. 
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
9 
 
4.2 
Insurance Pre-Authorization 
As some private insurance carriers will not cover SBRT to the prostate it is highly 
recommended that pre-authorization be completed before enrolling the patient on study. 
Patients whose insurance carriers do not cover SBRT of the prostate need to be advised 
before proceeding with study enrollment. 
 
5.0 
Radiation Therapy 
5.1 
Dose Specifications 
5.1.1 
Stereotactic Targeting and Treatment 
This protocol will require treatments to be performed with a stereotactic technique with 
the use of a 3-D coordinate system defined by implanted transponders (Calypso) or use of 
the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.  
 
Dose Fractionation 
Patients will receive 5 fractions of radiation. Each fraction size will be 7.4 Gy. The total 
dose will be 37 Gy. The 5 treatments will be scheduled to be delivered every other day. A 
minimum of 36 hours should separate each treatment.  No more than 3 fractions will be 
delivered per week.  The total duration of treatment will be no shorter than 10 days and 
no longer than 18 days.  
 
5.2 
Supportive Measures 
5.2.1 
Urinary  
Symptomatic urinary medicines, (e.g. tamsulosin) are allowed at the discretion of 
the treating radiation oncologist or urologist.  
5.2.2 
Bladder 
Patients will be asked to have a full urinary bladder both during simulation and 
treatment.  This may be achieved by asking patients to drink 16-24 oz of water or 
other fluid 2-3 hours prior to treatment and to not urinate between this time and 
treatment as they are able. 
5.2.3 
Bowel 
One tablespoon of Milk of Magnesia will be taken the night before the simulation 
and the night before each treatment. One Fleet’s enema will be administered 2-3 
hours before the simulation and each treatment. 
 
5.3 
Technical Factors 
5.3.1 
Radiotherapy delivery 
Megavoltage radiation therapy will be utilized with 6 to 21 MV photons. Standard 
quality assurance measures will be taken prior and during radiation therapy. 
 
5.4 
Set-up, Localization and Tracking 
5.4.1 
Patient Set-up 
Patients will be positioned supine in a comfortable posture. The minimum 
immobilization apparatus will be a pillow under the knees and the feet taped or 
rubber-banded together or equivalent. More complex immobilization devices are 
allowed, as per the discretion of the treating physician, as long as they do not 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
10 
 
interfere with the proper functioning of the image-guidance (Calypso, ExacTrac 
and cone-beam CT) system. 
5.4.2 
Localization 
The Calypso or ExacTrac or cone-beam CT system will be utilized for both 
localization and tracking/monitoring. The initial localization and alignment is 
based on the center of mass of the transponders/fiducial markers. After initial 
localization is performed, all effort should be made to initiate the treatment 
delivery as quickly as possible.  Significant rotations may be corrected at initial 
localization stage, and intra-fractional rotations will be ignored. Further 
adjustment during the treatment will be translational shift of the center of mass 
determined via Calypso or ExacTrac, using remote couch motion. 
 
5.5 
Treatment Planning 
5.5.1 
Simulation 
Computed Tomography (CT)  
CT will be the primary image platform for treatment planning.  The simulation 
should be performed in the supine treatment position, with the 
transponders/fiducial markers in place. Axial cuts of 3 mm or less will be 
acquired throughout the pelvis with slices of 1 mm thickness through the prostate 
(defined as 1 cm cranial to the cranial most point of the prostate gland or 
transponder/fiducial markers to 1 cm caudal to the prostate gland or inferior most 
transponder/fiducial marker). 
 
MRI 
MRI images are not required. However, if MR scan is planned with use of 
Calypso system, MR should be obtained prior to the implantation of transponders.  
 
Contrast  
Oral, IV, urethral, and bladder contrast are allowed but not required.  
 
5.5.2 
Treatment Planning/Target Volumes 
1. The definition of volumes will be in accordance with the ICRU Report #50 and 
ICRU Report #62: Prescribing, Recording, and Reporting Photon Beam Therapy. 
2. The Gross Tumor Volume (GTV) is defined by the physician as all known 
disease as defined by the planning CT and MR along with clinical information. 
The GTV for the purposes of this protocol is the prostate only.  
3. The clinical target volume (CTV) will be the same as the GTV and will consist 
of the prostate without the seminal vesicles as defined by non-contrast axial CT 
scan. 
4. The planning target volume (PTV) will be defined as the CTV plus a 3 mm 
margin posteriorly and 5mm in all other dimensions. 
 
5.5.3 
Dosimetry 
1. Intensity Modulated Radiotherapy (IMRT) beam arrangements will be designed 
with a minimum of 5 non-opposed fields.  Rotational IMRT is also allowed 
provided it demonstrates equivalent dosimetry compared to standard IMRT. If 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
11 
 
rotational IMRT delivery is used for planning, a corresponding fixed gantry 
IMRT plan should also be generated. 
2. Axial or non-axial beam arrangements may be utilized as per institutional 
preference.  
3. The prescription isodose line must encompass at least 95% of the PTV with a 
maximal differential between the prescription isodose line and the maximum dose 
to the PTV of 15%. Maximal dose to the PTV is defined as to 1cc or 1% of PTV.  
In addition, <10% of the PTV or < 5 cc (whichever is smaller) should be treated 
to >112% of the prescription dose.  
4. Adequate dose conformality to the PTV, defined as the ratio of prescription 
isodose volume to PTV volume of < 1.2, should be achieved.   
5. The volume of all tissues outside the PTV receiving > 100% of the prescription 
dose should be < 15% of PTV volume.  
6. Ideally hot spots will be manipulated to occur within the peripheral zones of the 
prostate itself avoiding the prostate-rectal interface as defined by the CTV. 
 
5.6 
Critical Structures 
5.6.1 
Critical Organ Dose-Volume Limits 
1. The normal tissue volume to be contoured will include bladder, rectum, 
bilateral femora (to the level of ischial tuberosity), seminal vesicles, penile bulb, 
and skin.  
2. The normal tissues will be contoured and considered as solid organs.  
3. The bladder should be contoured from its base to the dome 
4. The rectum should be contoured from the anus (at the level of the ischial 
tuberosities) for a length of 15 cm or to the rectosigmoid flexure. This generally is 
below the bottom of the sacroiliac joints. 
5. The seminal vesicles will be contoured from the cranial most aspect of the 
prostate superiorly as one structure (right and left).  The seminal vesicles are not a 
target for this trial but dosimetric data will be collected for later analysis. 
7. The tissue within the skin and outside all other critical normal 
structures and PTVs are designated as unspecified tissue. 
8. The following table lists maximum dose limits to a point or volume within 
several critical organs.  These are absolute limits, and treatment delivery that does 
not abide by these limits will constitute a major protocol violation.  The dose is 
listed as total over 5 fractions and per fraction.  
 
Organ 
Volume 
Dose (Gy) 
Prostate (PTV) 
Maximum point dose (1cc) 
≤ 43.0 Gy (8.5 Gy per fraction) 
115% of prescription dose 
The smaller of 10% or 5 cc 
≤41.9 Gy (8.3 Gy per fraction) 
112% of prescription dose 
Minimum 95% 
≥ 37 Gy (7.4 Gy per fraction) 
100% of prescription dose 
Rectum  
Maximum point dose (1cc) 
≤39.3 Gy (7.8 Gy per fraction) 
105% of the prescription dose 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
12 
 
Less than 2 cc 
> 37 Gy (7.4 Gy per fraction) 
100% of prescription dose 
75% rectum 
≤33 Gy (6.6 Gy per fraction) 
90% of prescription dose 
60% rectum 
≤28 Gy (5.6 Gy per fraction) 
75% of prescription dose 
50% rectum 
≤24 Gy (4.8 Gy per fraction) 
65% of prescription dose 
Bladder 
Maximum point  dose (1cc) 
40.7 Gy (8.14 Gy per fraction) 
110% of prescription dose 
Less than 40 cc 
>24 Gy (4.8 Gy per fraction) 
65% of prescription dose 
Penile bulb 
Maximum point  dose 
No more than 100% of prescription 
dose 
Less than 3 cc 
20 Gy (4 Gy per fraction) 
54% of prescription dose 
Femoral heads 
Skin 
Less than 10 cc cumulative 
(both sides) 
20 Gy (4  Gy per fraction) 
54% of prescription dose 
Maximum point  dose 
30 Gy (6 Gy per fraction) 
81% of prescription dose 
Seminal Vesicles 
No dose constraint 
Collect for documentation only 
 
5.7 
Image/signal-guidance for target localization 
5.7.1 
After patient is setup on the treatment table, either the Calypso system or 
ExacTrac or cone-beam CT system will be used to align the patient with the 
treatment machine geometry based on the treatment plan. The alignment result 
will be evaluated by the attending physician and attending physicist and be 
approved for treatment by attending physician. The alignment data will be 
recorded. 
 
5.7.2 
If the Calypso tracking system is used for localization of the prostate, it will be 
used during the treatment to track the target motion. A correction action will be 
performed if the target migrated more than 2 mm for more than 20 seconds in any 
of three orthogonal coordinates.  
 
5.7.3 
If an ExacTrac system is used for prostate localization with implanted markers, 
stereotactic images should be taken at least twice during the treatment (or at least 
every 1 minute). 
 
5.7.4 
Cone-beam CT (CBCT) images should be taken prior to radiation delivery but 
after image-guidance with method described either with 6.7.2 or 6.7.3 and also 
taken immediately after the radiation treatment. For some special cases, CBCT 
images may be taken more frequently during the treatment per physician’s clinical 
judgment.  
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
13 
 
5.7.5 
The initial localizations and alignment is based on the center of mass of the 
transponders/fiducial markers. Significant rotations may be corrected at initial 
localization stage, and intra-fractional rotations will be ignored. Further 
adjustment during the treatment will be translational shift of the center of mass 
determined via Calypso or ExactTrac or CBCT, using remote couch motion. 
 
5.7.6 
The physicist will be on-site for image guidance and treatment. For any image-
guidance procedure, comparison with reference images or baseline data should be 
performed and reviewed and approved by both physician and physicist on site. 
The comparison can be done both manually and automatically. For any image-
guidance method, if any deviation is larger than 2 mm, correction should be 
performed.  
 
5.7.7 
All image/signal-guidance data should be recorded for post treatment review and 
analysis. In some case, replanning (either offline or online) based anatomy of the 
day may be performed. Such request will be made by the attending physician. 
 
5.8 
Radiation Toxicity 
Patients will be seen weekly by their radiation oncologist during radiation therapy. Any 
observations regarding radiation reactions will be recorded and should include attention 
toward the following potential side effects: 
5.8.1 
Small bowel or rectal irritation manifesting as abdominal cramping, diarrhea, 
rectal urgency, proctitis, or hematochezia 
 
5.8.2 
Bladder complications including urinary frequency/urgency, dysuria, hematuria, 
urinary tract infection, and incontinence 
 
5.8.3 
Radiation dermatitis 
 
5.8.4 
Clinical discretion may be exercised to treat side effects from radiation therapy. 
Rectal side effects such as diarrhea may be treated with diphenoxylate or 
loperamide. Bladder or rectal spasms can be treated with anticholinergic agents or 
tolterodine. Bladder irritation can be managed with phenazopyridine. Dysuria 
may be managed with ibuprofen. Erectile dysfunction can be treated with 
phosphodiesterase (PDE) inhibitors (sildenafil). 
 
5.9 
Radiation Adverse Event Reporting 
Adverse events (AEs) and serious adverse events (SAEs) will be recorded in study database. 
Related and unexpected SAEs will be reported to the DUHS IRB per IRB policy. Sites are 
responsible for reporting any related and unexpected SAEs to their respective IRBs and also 
for notifying Dr. Lee and his Study Coordinator of such an event in order to facilitate 
reporting to the DUHS IRB in accordance with the required reporting timelines. Conversely, 
the DUHS study team is responsible for notifying all study sites of any reportable events in a 
timely fashion. 
 
Adverse Event Definition 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
14 
 
Definition of an AE: Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medical 
treatment or procedure regardless of whether it is considered related to the medical 
treatment or procedure (attribution of unrelated, unlikely, possible, probable, or definite).  
 
Definition of an SAE: Any adverse experience occurring at any dose that results in any of 
the following outcomes: 
 Death; 
 A life-threatening adverse experience; 
 Inpatient hospitalization or prolongation of existing hospitalization; 
 A persistent or significant disability/incapacity; 
 A congenital anomaly/birth defect. 
 
Important medical events that do not result in death, are not life threatening, or do not 
require hospitalization may be considered an SAE experience, when, based upon medical 
judgment, they may jeopardize the patient and may require medical or surgical intervention 
to prevent one of the outcomes listed in the definition. 
 
Note: All deaths on study require both routine and expedited reporting regardless of 
causality. Attribution to treatment or other cause must be provided. “On study” is 
defined as during or within 30 days of completing protocol treatment. 
 
Expected events - Expected events are those that have been previously identified as 
resulting from treatment of prostate cancer with radiation therapy. For purposes of this 
study, reporting requirements are determined by the assessment of the following adverse 
event characteristics: the type or nature of the event; the severity (grade); the relationship to 
the study therapy and whether the event is expected or unexpected.  
 
Recommended assessment steps include:  
Identification of adverse events using the NCI CTCAE Version 4.0 terminology. A copy of 
the CTCAE can be downloaded from the CTEP home page (http://ctep.cancer.gov). 
Grading the severity of the adverse event using the NCI CTCAE Version 4.0. 
Determination as to whether the adverse event is related to the study therapy using the 
following categories: Unrelated, Possible, Probable, and Definite. 
Determine whether the adverse event is expected or unexpected. 
 
REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS THAT 
OCCUR WITHIN 30 DAYS OF THE DATE OF THE LAST RADIATION 
TREATMENT 
 
 
 
Grade 3 or 4 
Grade 4  
Grade 4 & 5 
Unexpected 
 
With 
Hospitalization 
 
Without 
Hospitalization 
Expected  
 
Unrelated, Unlikely 
Not required 
Not required 
10 Calendar Days 
Possible, Probable or 
Unexpected 
Not required 
5 Calendar Days 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
15 
 
Definite 
10 Calendar Days 
 
Any late death (> 30 days after end of radiation) attributed to the protocol treatment 
should be reported within 10 calendar days of the PI learning of the event. 
 
REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS THAT 
OCCUR > 30 DAYS OF THE DATE OF THE LAST RADIATION TREATMENT 
 
Grade 3  
Unexpected with 
Hospitalization 
Grade 4 & 5 
Unexpected 
Grade 4 & 5 
Expected 
Possible, Probable or 
Definite 
15 Calendar Days 
10 Calendar Days 
15 Calendar Days 
 
6.0 Study Visits 
6.1 
Study Presentation  
Following the request of the patient’s radiation oncologist, the patient will be given the 
consent form, provided time to review it and ask any questions regarding his participation 
in the study.  After the subject has consented, the study team will collect the information 
required to complete eligibility. The patient will be asked to complete the AUASS, IIEF 
and EPIC-26 if not already available from his previous clinical visit(s). 
 
6.2 
Treatment Planning  
During this period, the subject will have prostate imaging and treatment planning per 
standard practice.  
 
6.3 
SBRT 
During SBRT visits, the subject should receive therapy according to the treatment plan 
based on the anatomy of the day from the CBCT accomplished prior to each treatment.  At 
each fraction, the physicist or designee should record the following information: 
o The date and number of the fraction 
o Whether the patient was successfully localized and tracked using the image 
guidance system. 
o Whether the patient required any interventions due to the information provided by 
the image guidance system, if so the nature of the intervention 
o If reoptimization is requested by the attending physician, the physicist will 
perform plan reoptimization based on the anatomy of the day and previous 
optimization results. The minimum QA for modified plan will include MU 
verification using an independent software and analysis of MLC delivery information 
in the Dialog file from the treatment machine.  
 
6.4 
Treatment Checks 
Patients will be seen and evaluated weekly during radiation with documentation of 
tolerance, including acute reactions.  
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
16 
 
6.5 
Follow-up Visits 
Patients will be seen approximately at 1, 3, 6, 12, 18, 24, 36 months following the end of 
radiotherapy. Follow-up visits may occur at the Department of Radiation Oncology or with 
referring providers. At each visit (see table) the patient will have an interval history, 
focused physical examination (digital rectal examination at the physician discretion), and 
assessment of specific GU and GI toxicity. PSA will be assessed before or at each follow-
up visit. 
 
6.6 
Patient Assessments 
Patient assessments are described below, some variation with respect to visit timing is 
permissible to allow for individual patient needs and clinic schedules.  
 
      
1Focused physical exam. Digital rectal exam (DRE) at the discretion of the physician. 
2. CBCT to be performed prior to each treatment and reoptimization performed if needed. 
3  As per standard clinic practice.  
4  Baseline PSA must be within 180 days of study registration. 
 
6.7 
Data Collection 
Data management will be performed by the study personnel under the direction of the 
study PI. GU and GI toxicity data will be collected at all sites using an appropriate adverse 
events (AE) application, such as NCI’s Cancer Adverse Event Reporting System 
(caAERS).  Demographic, pathology, PSA,IIEF, AUA and other pertinent study data will 
 
Baseline 
SBRT 
Planning 
During 
RT 
1 
Mo 
3 
Mo 
6 
Mo 
12 
Mo 
18 
Mo 
24 
Mo 
36 
Mo 
Medical 
History 
X 
 
 
 
 
 
 
 
 
 
Physical 
Exam   
X 
(including 
DRE) 
 
 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
Planning 
CT/MR 
 
X 
X2 
 
 
 
 
 
 
 
Prostate 
Measurement 
X 
 
 
 
 
 
 
 
 
 
Transponder 
or Fiducial 
Marker 
Placement 
 
X 
 
 
 
 
 
 
 
 
AUASS, IIEF 
3 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
EPIC-26 QOL 
X 
 
 
 
X 
 
X 
 
X 
X 
Toxicity 
Assessment 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
PSA 
X4 
 
 
 
X 
X 
X 
X 
X 
X 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
17 
 
be collected at all sites and entered into a study specific secure database.  See Appendix 3 
for data fields. 
6.8 
Adverse Events Classification 
Adverse events will be recorded at each study visit.  These adverse events will be classified 
in accordance to the CTCAE ver. 4.0. 
 
7.0 
Statistical Analysis Plan 
7.1 
Primary End Point 
The primary end-point of the study is the safety of delivering SBRT to the prostate.  The 
dose and fractionation of radiation is determined such that the risk of late complications 
should be equivalent to the BED3Gy of 78 Gy in 2 Gy fractions. 
 
A conservative estimate of grade 3 rectal toxicity for this regimen of 78 Gy in 2 Gy 
fractions is 1.5% at 2 years.  Therefore, with a patient population of 60 patients if the true 
rate of grade 3 or higher rectal toxicity is 1.5% there will be a 77% power to rule out a 
>7.1% rate.  If the true rate is 2.5%, there will be an 81% power of ruling out a >9.6% rate. 
 
Incidence of GU and GI Acute and Late Adverse Events 
Adverse events are scored according to CTCAE version 4.0. An acute adverse event will 
be defined as an adverse event occurring less than or equal to 90 days from the completion 
of RT. Both unadjusted and adjusted odds ratios and the respective 95% confidence 
interval will be computed.  
 
A late adverse event will be defined as an adverse event occurring more than 90 days from 
the completion of RT. The time to late adverse events will be measured from the time that 
protocol treatment is completed (i.e., the completion of radiation) to the time of the worst 
late adverse event. If no such late adverse event is observed until the time of the analysis, 
the patient will be censored at the time of the analysis. The distribution of time to late 
adverse events (observed severities of adverse events over time) will be estimated. 
 
7.2 
Secondary End-Points 
7.2.1 
Disease-free survival: Disease-free failure events include local progression, 
distant progression, biochemical recurrence as defined by the RTOG Phoenix 
definition, and death from any cause. 
7.2.2 
Analysis for Endpoints Related to EPIC-26 QOL  
We will use the Expanded Prostate Cancer Index Composite (EPIC-26) 
instrument to measure QOL. Protocol eligible patients will be included in the 
QOL analysis only if they have provided baseline and at least one subsequent 
measurement. The EPIC-26 instrument is intended to be collected on all cases 
participating in the trial. 
 
The EPIC-26 will be collected at pretreatment (baseline) and at 3, 12, 24 months, 
and 3 years after therapy starts. Patient self-assessment of symptoms will be 
performed using three primary EPIC scales: urinary, bowel, and sexual 
symptoms. 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
18 
 
 
7.3 
Sample Size and Patient Accrual 
We anticipate that this study will begin enrolling subjects in the Fall 2009 and will enroll 2 
subjects a month for 30 months for a total enrollment of 60. This projection is based on the 
250 newly diagnosed prostate cancer patients seen in the Department of Radiation 
Oncology each year, of which at least 75 should be eligible for this study.  
 
7.4 
Stopping Rules for Excessive Adverse Events 
 
We estimate ≤ 7.5% of the men will experience a grade 3+ adverse event. For this study, a 
rate of 5% grade 3+ GU and GI adverse events (pt) according to the CTCAE version 4.0 
within 24 months of the start of radiation therapy is considered acceptable. A rate of 20% is 
considered unacceptable. The null hypothesis (H0) is that this radiation therapy is not 
tolerable versus the alternative hypothesis (HA) that this radiation therapy is tolerable. 
With 60 patients the power to reject the null hypothesis is >90%.  
 
The stopping and continuation rules in the Table below will be applied in two stages to the 
first analyzable 30 cases who received at least some treatment. Analyzable patients are 
defined as eligible patients who received at least some treatment. If at any stage, we show 
that the grade 3+ GU and GI adverse event rate may be greater than or equal to 20%, we 
would temporarily close the study to accrual, gather the relevant source data on the cases 
with grade 3+ GU and GI adverse events, prepare a statistical report summarizing the 
adverse event findings, and present the report to the radiation oncology and GU 
multidisciplinary team for review. The GU team will review all source documentation on 
the analyzed cases with adverse events and the statistical report summarizing the findings 
as soon as possible. Following the review of the data, the team will discuss the findings and 
make a recommendation about the study. If at the first or second stage either of the 
stopping rules is not met, we will continue accrual and monitoring for grade 3+ GU and GI 
adverse events. If we continue until the last stage, then we will either conclude 
“tolerability” or not. 
 
Stopping and Continuation Rules for Grade 3+ GU/GI Adverse Events 
Number of Analyzable 
Patients * 
 
Reject H0 pt ≥ 0.2 and 
continue 
Reject HA : pt ≤ 0.05 and 
stop 
 
15 
≤ 2 
 
≥ 3 
30 
≤ 3 
≥ 4 
 
* Analyzable patients are defined as eligible patients who received at least some treatment. 
 
 
 
 
 
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
19 
 
8.0 
References 
 
 
(1)  Shipley WU, Thames HD, Sandler HM, Hanks GE, Zietman AL, Perez CA et al. Radiation 
therapy for clinically localized prostate cancer: a multi-institutional pooled analysis. JAMA 1999; 
281(17):1598-1604. 
 
(2)  Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA et al. Escalated-dose 
versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 
randomised controlled trial. Lancet Oncol 2007; 8(6):475-487. 
 
(3)  Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR et al. Long-term results 
of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol 
Biol Phys 2008; 70(1):67-74. 
 
(4)  Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF et al. Dose-
response in radiotherapy for localized prostate cancer: results of the Dutch multicenter 
randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol 2006; 
24(13):1990-1996. 
 
(5)  Zietman AL, Desilvio ML, Slater JD, Rossi CJ, Jr., Miller DW, Adams JA et al. Comparison of 
conventional-dose vs high-dose conformal radiation therapy in clinically localized 
adenocarcinoma of the prostate: a randomized controlled trial. JAMA 2005; 294(10):1233-1239. 
 
(6)  Pollack A, Zagars GK, Smith LG, Lee JJ, von Eschenbach AC, Antolak JA et al. Preliminary 
results of a randomized radiotherapy dose-escalation study comparing 70 Gy with 78 Gy for 
prostate cancer. J Clin Oncol 2000; 18(23):3904-3911. 
 
(7)  Huang EH, Pollack A, Levy L, Starkschall G, Dong L, Rosen I et al. Late rectal toxicity: dose-
volume effects of conformal radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys 2002; 
54(5):1314-1321. 
 
(8)  Fowler JF. The radiobiology of prostate cancer including new aspects of fractionated 
radiotherapy. Acta Oncol 2005; 44(3):265-276. 
 
(9)  Fowler JF, Ritter MA, Chappell RJ, Brenner DJ. What hypofractionated protocols should be 
tested for prostate cancer? Int J Radiat Oncol Biol Phys 2003; 56(4):1093-1104. 
 (10)  Miles EF, Lee WR. Hypofractionation for prostate cancer: a critical review. Semin Radiat Oncol 
2008; 18(1):41-47. 
 (11)  Madsen BL, Hsi RA, Pham HT, Fowler JF, Esagui L, Corman J. Stereotactic hypofractionated 
accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: 
First clinical trial results. Int J Radiat Oncol Biol Phys 2007; 67(4):1099-1105. 
 
 (12)  King CR, Brooks JD, Gill H, Pawlicki T, Cotrutz C, Presti JC, Jr. Stereotactic Body Radiotherapy 
for Localized Prostate Cancer: Interim Results of a Prospective Phase II Clinical Trial. Int J 
Radiat Oncol Biol Phys 2008; . 
 
9.0 Appendices 
 
Appendix 1  
AJCC Staging System 6th edition  
 
Appendix 2 
The Expanded Prostate Cancer Index Composite (EPIC-26) 
Appendix 3      SBRT Dosimetry Worksheet 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
20 
 
 
9.1 
Appendix 1 
AJCC Staging System – Prostate, 6th Edition  
DEFINITION OF TNM 
Primary Tumor, Clinical (T) 
TX  
Primary tumor cannot be assessed 
T0  
No evidence of primary tumor 
T1  
Clinically inapparent tumor not palpable or visible by imaging 
T1a 
Tumor incidental histologic finding in 5% or less of tissue resected 
T1b  
Tumor incidental histologic finding in more than 5% of tissue resected 
T1c  
Tumor identified by needle biopsy (e.g., because of elevated PSA) 
T2  
Tumor confined with prostate* 
T2a  
Tumor involves less than ½ of one lobe 
T2b  
Tumors involves greater than ½ of one lobe but < 2 lobes 
T2c  
Tumor involves both lobes 
T3  
Tumor extends through prostate capsule** 
T3a  
Extracapsular extension (unilateral or bilateral) 
T3b  
Tumor involves the seminal vesicle(s) 
T4  
Tumor is fixed or invades adjacent structures other than the seminal vesicles: bladder neck, 
external sphincter, rectum, levator muscles and/or pelvic wall 
 
*Note: Tumor found in one or both lobes by needle biopsy, but not palpable or reliably visible by 
imaging, is classified as T1c 
**Note: Invasion into the prostatic apex or into (but not beyond) the prostatic capsule is not classified as 
T3, but as T2. 
 
Regional Lymph Nodes (N) 
Clinical 
NX Regional lymph nodes cannot be assessed 
N0 No regional lymph node metastasis 
N1 Metastasis in regional lymph node or nodes 
Pathologic 
pNX Regional nodes not sampled 
pN0 No positive regional nodes 
pN1 Metastases in regional node(s) 
 
Primary Tumor, Pathologic (pT) 
pT2***  
Organ confined 
pT2a   
Unilateral 
pT2b   
Bilateral 
pT3  
 
Extraprostatic extension 
pT3a   
Extraprostatic extension 
pT3b   
Seminal vesicle invasion 
pT4  
 
Invasion of bladder, rectum 
***Note: There is no pathologic T1 classification 
 
Appendix 1  AJCC Staging System – Prostate Continued 
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
21 
 
Distant Metastasis**** (M) 
MX  
Presence of distant metastasis cannot be assessed 
M0  
No distant metastasis 
M1  
Distant metastasis 
M1a  
Non regional lymph node(s) 
M1b  
Bone(s) 
M1c  
Other site(s) 
****Note: When more than one site of metastasis is present, the most advanced category is used. 
pM1c is most advanced 
 
Histopathologic Grade (G)  
GX  
Grade cannot be assessed 
G1  
Well-differentiated (slight anaplasia) 
G2  
Moderately differentiated (moderate anaplasia) 
G3-4  Poorly undifferentiated or undifferentiated (marked anaplasia) 
 
Stage Grouping 
Stage I   
T1a  
N0  
M0  
G1 
 
Stage II  
T1a  
N0  
M0  
G2, G3-4 
 
T1b  
N0  
M0  
Any G 
T1c  
N0  
M0  
Any G 
T1  
N0  
M0  
Any G 
T2  
N0  
M0  
Any G 
 
Stage III  
T3  
N0  
M0  
Any G 
 
Stage IV  
T4  
N0  
M0  
Any G 
Any T  N1 
M0  
Any G 
Any T Any N  M1  
Any G 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
22 
 
9.2 
Appendix 2   EPIC-26 
Expanded Prostate Cancer Index Composite Short Form 
 
 
 
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
23 
 
 
 
 
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
24 
 
 
 
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
25 
 
 
 

Duke Prostate SBRT 
26 
9.3 
Appendix 3     Data Collection: Dosimetry and Initial Evaluation 
 
Patient Initials:  ____  ____  ____  
Subject Study ID Number:  _____________________ 
 
1. Prostate volume (CTV)   
 
 
 
 
 
 
__________  cc  
2. Prostate planning target volume (PTV)  
 
 
 
 
__________  cc 
3. Conformality index (Volume of prescription isodose surface / volume of PTV) 
__________ 
 
4. Minimum dose to 1% of prostate planning target volume (P + 0.3) 
 
______ . ______  Gy 
5. Maximum dose to 1% of prostate planning target volume (P + 0.3)  
 
______ . ______  Gy 
6. Mean dose to the prostate planning target volume (P + 0.3)    
 
 
______ . ______  Gy 
7. Bladder volume at time of planning CT  
 
 
 
 
______________  cc 
8. Maximal dose delivered to 2 cc or more of bladder 
 
 
 
______ . ______  Gy  
9. Percent and absolute volume of bladder > 37 Gy (V100)  
 
 
_______ %      _____  cc 
10. 
Percent and absolute volume of bladder > 33 Gy (V90)  
 
_______ %      _____  cc 
11. 
Percent and absolute volume of bladder > 28 Gy (V75)  
 
_______ %      _____  cc 
12. 
Percent and absolute volume of bladder >24 Gy (V65) 
 
 
_______ %      _____  cc  
13. 
Percent and absolute volume of bladder >18.5 Gy (V50)  
 
_______ %      _____  cc 
14. 
Mean dose to prostatic urethra  
 
 
 
 
______ . ______  Gy  
15. 
Maximal dose to 10% of prostatic urethra 
 
 
 
______ . ______  Gy  
16. 
Rectal volume at time of planning CT 
 
 
 
 
______________  cc 
17. 
Maximal dose delivered to 2 cc or more of rectum 
 
 
______ . ______  Gy  
18. 
Percent and absolute volume of rectum > 37 Gy (V100)  
 
_______ %      _____  cc 
19. 
Percent and absolute volume of rectum > 33 Gy (V90) 
 
 
_______ %      _____  cc 
20. 
Percent and absolute volume of rectum > 28 Gy (V75) 
 
 
_______ %      _____  cc 
21. 
Percent and absolute volume of rectum > 24 Gy (V65) 
  
 
_______ %      _____  cc 
22. 
Percent and absolute volume of rectum > 18.5 Gy (V50)  
 
_______ %      _____  cc 
23. 
Mean dose to right femoral head  
 
 
 
 
_____ . _____ Gy 
24. 
Mean dose to left femoral head    
 
 
 
 
_____ . _____ Gy 
25. 
Energy   
 
 
 
 
 
 
 
_______ MV 
26. 
Number of fields:  
 
 
 
 
 
 
 
________ 
27. 
 Non-axial beams?   
 
 
 
 
 
 
 
Yes or No 
28. 
Date of first fraction 
 
 
 
 
 
 
________________ 
29. 
Date of last fraction 
 
 
 
 
 
 
________________ 
30. 
Elapsed time (days) from first fraction to last fraction: 
 
 
________________ 
31. 
Institution Patient treated at:  
 
 
 
_______________________________ 
32. 
Mode (Calypso=1, ExacTrac=2) 
 
 
 
Age at time of enrollment 
 
Month and Year of birth 
 
Race 
 
Zip code 
 
Date of Prostate Biopsy 
 
Combined Gleason Score 
 
Primary Gleason Pattern 
 
Secondary Gleason Pattern 
 
Number of cores (biopsy) 
 
Number of positive cores (biopsy) 
 

Duke Prostate SBRT 
 
Version: 17-June-2013 
 
27 
 
Lobes (Right, Left or Bilateral) 
 
Duke Pathology Review (Y or N) 
 
Hx of Previous Biopsy (Y or N) 
 
PSA Date 
 
PSA level 
 
T stage 
 
Zubrod Baseline 
 
AUA Score Baseline 
 
AUA Bother score Baseline 
 
IIEF Baseline 
 
 
 
Follow-up Data 
 
ID 
Participant 
3mo  
6mo  
12mo  
18mo  
24mo  
36mo  
 
PSA 
 
  
  
  
  
  
  
Date 
 
  
  
  
  
  
  
AUA Score