Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer
Phase: NA
Conditions: Prostate Cancer
Sponsor: Mercy Research

Version 5 (8/1/16) 
 
 
 
 
 
 
 
 
 
 
PHASE IV TRIAL EVALUATING THE USE OF STEREOTACTIC 
BODY RADIOTHERAPY FOR THE TREATMENT OF  
PROSTATE CANCER 
 
 
 
 
 
Investigators 
 
 
 
Radiation Oncology 
Jaymeson Stroud, M.D. 
 
 
Robert Frazier, M.D. 
 
 
Kathy Baglan, M.D. 
 
 
Julie Mai, M.D. 
 
 
 
Jeffrey Craft, M.D. 
 
 
Matthew Johnson, M.D. 
David C. Pratt Cancer Center 
 
 
(314) 251-6844 
 
 
Fax (314) 251-4337 
Oncology Research 
Bethany Sleckman, M.D. 
 
David C. Pratt Cancer Center 
 
(314) 251-7057 
 
Fax (314) 251-5665 
 
Original version Date: 
January 31, 2011 
Amendment 1: 
April 29, 2011 
Amendment 2: 
May 16, 2011 
Amendment 3:  
December 18, 2013 
Amendment 4: 
October 26, 2013 
Amendment 5: 
August 1, 2016 
 
 

2 
 
Index 
 
 
 
Schema……………………………………………………………………………………………… 3 
1   Introduction…………….. ……………………………………………………………………………4 
2 
Objectives 
 
2.1 
Hypothesis ………………………….……………………………………………………….7 
 
2.2 
Study Design ……………………………………………….………………………………. 7 
 
2.3 
Endpoints ………………………….………………………………………………………...7 
3 
Patient Selection  
 
3.1 
Eligibility Criteria …………………………………………………………………………...7 
 
3.2 
Exclusion Criteria …………………………………………………………………………...7 
4 
Pretreatment Evaluation …………………………………………………………………………….8 
5 
Fiducial Placement…………………………………………………..………………………………8  
6 
Simulation ……………………………………………………………………………………….….8 
7 
Radiation Treatment Planning 
 
7.1 
Target Definition ……………………………………………………………………………8 
 
7.2 
Dose Specification …………………………………….…………………………………….8 
 
7.3 
Normal Tissue Dose Constraints ………………………………………………………….…9 
8 
Stereotactic Body Radiotherapy Treatment Delivery 
 
8.1 
Premedication ……………………………………………………………………………….9 
 
8.2 
Treatment …………………………………………………………………………………...10 
9 
Drug Therapy ……………………………………………………………………………………….10 
10 Patient Assessment 
 
10.1 Study Parameters ……………………………………………………………………………10 
 
10.2 Response Evaluation ……………………………………………………………………….. 11 
 
10.3 Toxicity ……………………………………………………………………………………...11 
 
10.4 Patient Withdrawal ………………………………………………………………………….12 
11 Risk/Benefit Analysis 
 
 
11.1 Risk associated with SBRT for organ confined prostate cancer………………..……….…. 12 
 
11.2 Minimization of Risks ………………………………………………………………………12 
 
11.3 Potential Patient Benefits …………………………………………………………………... 12 
 
11.4 Justification of the Study ……………………………………………………………………12 
 
11.5 Statistical Analysis ………………………………………………………………………….13 
12 References …………………………………………………………………………………………..13 
13 Appendices 
 
13.1 Appendix I – Sample Informed Consent ……………………………..….…………………..15 
 
13.2 Appendix II – Performance Status …………………………………..….…………………...20 
 
13.3 Appendix III – Toxicity Score ……………………………….…...…………………………21 
 
13.4 Appendix IV – AUA Symptom Score Sheet ……..…………………………………………24 
 
13.5 Appendix V – EPIC Questionnaire….………………………………….…………………...25 
 
13.6 Appendix VI – Patient Demographic Form ……………………..…..…….…………….…..34 
 
13.7 Appendix VII – Treatment Form …………………………………………………………....35 
 
13.8 Appendix VIII – Patient Follow-up Form ……….…………..………………………….…. 37 
 
 
 
 
 
 
 
 

3 
 
PHASE IV TRIAL EVALUATING THE USE OF STEREOTACTIC 
BODY RADIOTHERAPY FOR THE TREATMENT OF  
PROSTATE CANCER 
 
 
SCHEMA 
 
 
R  
 
 
 
 
 
 
 
E 
      Stereotactic Body Radiotherapy (SBRT) 
 
 
 
 
  
 
G 
 
 
  
 
 
I 
Patient Groups: 
Prostate Cancer 
 
  
 
 
                                                                  
 
S 
Dose-Fractionation: 
 
 
  
 
 
 
 
  
 
As monotherapy (No pelvic radiotherapy):  
 
 
T 
 
 
30 – 40 Gy / 4 – 5 fractions 
 
 
 
 
 
 
E 
 
After standard pelvic radiotherapy (45 Gy) for higher risk disease: 
 
 
 
 
19 – 21 Gy / 2 – 3 fractions 
 
R 
 
 
 
 
  
 
 
 
 
 
Pelvic Radiotherapy 
Conventionally fractionated external beam pelvic radiotherapy to a dose of 45 Gy in 25 fractions may be 
given at the discretion of the treating radiation oncologist based on high risk features (i.e. PSA > 20, 
Gleason score > 7, T3 disease) or high intermediate risk features (i.e. Gleason Score 4 + 3= 7, PSA > 15). 
 
Integrated Boost 
At the discretion of the treating radiation oncologist, an integrated boost of ~ 1 Gy per fraction may 
be directed at the MR abnormality. 
 
Hormone Therapy 
Hormone therapy may be given at the discretion of the patient’s urologist and/or radiation oncologist 
based on high risk features.  All forms of androgen suppression including neoadjuvant, concurrent, and 
adjuvant hormone therapy may be recommended. 
 
Radioprotectant 
Rectal amifostine is encouraged but not required and may be given at the discretion of the treating 
radiation oncologist prior to each fraction. (See 8.1.6) 
 
Eligibility 
- Patient age > 18 years 
- Zubrod performance status of 0-3 
-  Biopsy-proven prostatic adenocarcinoma, clinical stage T1-3N0M0 
-  Prostate volume ≤ 100 cc 
-  No prior prostatectomy 
-  No prior central pelvis radiotherapy except as part of combination therapy for prostate cancer 
-  No history of scleroderma 
- Signed study-specific consent form 

4 
 
1.0   
Introduction  
 
Prostate cancer is the most common cancer among American men. The American Cancer Society 
estimated about 192,280 new cases of prostate cancer in the United States in 2009. Prostate cancer is the 
second most common cause of cancer-related death with an estimated 27,360 men dying of prostate 
cancer in 2009. This accounts for 10% of all cancer-related deaths in men. However, with more than 2 
million survivors of prostate cancer alive today in the United States, much of the current research focuses 
not only on improvements in tumor control but also in convenience of treatment delivery and quality of 
life after treatment. (www.cancer.org) 
 
Due to a better understanding of the radiobiology of prostate cancer and the recent advances in 
precise delivery of radiation therapy, stereotactic hypofractionated radiotherapy is emerging as a new 
treatment modality with the potential to control organ confined prostate cancer while limiting treatment-
related toxicity. The survival of a mammalian cell to radiation damage is classically described by a 
formalism known as the linear quadratic equation. This mathematical model suggests that the survival 
rate of an irradiated cell depends on the total radiation dose, the dose per fraction and the overall 
treatment time. The dose-response of a cell to fractionated radiation is described by the alpha-beta ratio 
(α∕β ). A recent review of 17 articles estimated the α∕β ratio for prostate cancer cells to be 1.85 Gy which 
suggests that prostate cancer cells have a high sensitivity to fractionation, where higher doses of radiation 
delivered in fewer fractions would theoretically be advantageous.(1) Stereotactic body radiation therapy 
(SBRT) is a radiation delivery technique that employs state-of-the-art equipment to position a patient and 
precisely deliver a high dose of radiation to the treatment volume in a limited number of fractions (usually 
5 or less).  
Historically, hypofractionated radiation therapy has been reported as early as the 1960’s in 
attempts at the time to improve allocation of resources. Results from a retrospective review of a United 
Kingdom regimen of hypofractionated radiation therapy using 6 fractions of 6 Gy to a total dose of 36 Gy 
were found to be comparable to other published outcome data in terms of local tumor control and 
survival. Early and late toxicity were reportedly within normal limits. (3) Hypofractionation for prostate 
cancer has more recently moved into several radiation therapy arenas, including external beam 
radiotherapy, high dose rate brachytherapy and stereotactic radiotherapy. The Radiation Therapy 
Oncology Group (RTOG) currently has a phase III protocol open to patient accrual comparing 
conventionally fractionated conformal radiation therapy in 41 fractions of 1.8 Gy (73.8 Gy total) to 
hypofractionated conformal radiation therapy in 28 fractions of 2.5 Gy (70 Gy total). Other studies have 
used fraction sizes ranging from 2.5 to 3.1 Gy. (4-7) High dose rate brachytherapy has been used to 
deliver 5.5 to 11.5 Gy fraction sizes. (8-9).  
 
Recent technological advances have made it possible to deliver high doses of radiation therapy 
with high precision over just a few days while preserving function of surrounding critical structures.  This 
treatment modality, termed stereotactic body radiotherapy (SBRT), is emerging as an expedient, safe, and 
effective radiation modality for a variety of malignancies.  SBRT was recently defined by the American 
Society for Therapeutic Radiology and Oncology (ASTRO) as a “treatment method to deliver a high dose 
of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of 
precision within the body” (2).  Stereotactic radiotherapy is a well-established treatment for intracranial 
metastases with local control rates of 80-90%.   
Effective biochemical control with low rectal and bladder toxicity has been seen in several 
recently published clinical studies investigating stereotactic radiation therapy, mainly focusing on the 
feasibility of using SBRT to treat low-risk prostate cancer. New studies are also emerging that show 
safety and efficacy in using SBRT in intermediate and high risk prostate cancer patients as a boost after 
initial conventionally fractionated pelvic irradiation.  

5 
 
The early results of a Canadian phase I/II study (pHART3) using a five-fraction hypofractionated 
accelerated radiotherapy treatment (35 Gy in five daily fractions) for low risk organ confined prostate 
cancer were reported by Tang et al. After 6 months of follow up, there was no grade 3 toxicity; however, 
longer term follow-up is required to assess efficacy and toxicity. (10) Madsen et al. reported on 40 
patients treated with SBRT for low risk prostate cancer. They all received 33.5 Gy in five fractions, which 
is equivalent to 78 Gy in 2 Gy fractions based on alpha/beta ratio of 1.5. The actuarial 4-year biochemical 
progression-free survival was 90% with a median follow-up of 41 months. There were only two cases of 
grade 3 acute urinary toxicity. No late toxicity more than grade 3 was reported. (11) King et al. recently 
reported the Stanford experience of treating 41 low-risk prostate cancer patients with 5 fractions of 7.25 
Gy (36.25 Gy) using image-guided SBRT. After a median follow-up of 33 months, they reported no 
biochemical failure with early and late toxicity profiles no worse than conventional EBRT. In fact, they 
reported no patients with grade 4 or higher toxicities, only two patients with grade 3 late urinary toxicity 
and no grade 3 late rectal toxicity. In a separate report, they used the Expanded Prostate Cancer Index 
Composite (EPIC)-validated quality of life questionnaire to survey 32 consecutive patients treated with 
SBRT. The mean EPIC sexual domain summary score, sexual function score, and sexual bother score 
decreased by 45%, 49% ,and 25% respectively after 50 months of follow-up. The radiation dose to the 
penile bulb was not associated with erectile dysfunction. The investigators concluded that the rates of 
erectile dysfunction appeared comparable to those reported for other modalities of radiotherapy. (12-14)  
The results of a phase I dose escalation trial conducted by the University of Texas Southwestern 
Medical Center were presented at the American Society of Clinical Oncology 2010 Genitourinary 
Cancers Symposium. Forty-five patients with low to intermediate risk prostate cancer were treated with a 
5 fraction SBRT regimen using image guidance, intensity modulation, and a rectal balloon with 
pretreatment enema. The starting radiation dose was 45 Gy in 5 fractions with subsequent dose escalation 
to 47.5 Gy and 50 Gy. Patients were followed for toxicity using CTCAE (Common Terminology Criteria 
for Adverse Events) v3 scoring, as well as AUA (American Urological Association) and EPIC 
questionnaires. After a median follow-up of 12 months, the investigators observed no grade 3 
gastrointestinal toxicities and only one patient with grade 3 genitourinary toxicity. Mean AUA score 
before SBRT was 5 and during follow-up increased to 8-9. EPIC rectal mean scores were decreased at 6 
weeks to 12 months but returned to baseline at 18 months. PSA control was 95% using the nadir-plus-2 
definition and 100% using the 3-consecutive-rises definition. Currently, the phase II study that is being 
conducted utilizes 50 Gy in 5 fractions. (15)  
Katz et al. (16) also recently published their results with SBRT for localized prostate cancer. 
Three hundred and four patients were treated as follows: 50 received 5 fractions of 7 Gy (total dose 35 
Gy) and 254 received 5 fractions of 7.25 Gy (total dose 36.25 Gy). Two low risk patients and two high 
risk patients failed biochemically. However, biopsy revealed both of the low risk patients and one of the 
high risk patients to be disease free in the prostate gland. In this study, rectal administration of amifostine 
was given prior to each treatment which likely assisted in keeping toxicity low. In fact, despite higher 
therapeutic doses based on biological equivalent dose (BED) calculations, the observed rate of acute 
urinary and rectal toxicity was low, with less than 5% of patients experiencing any acute grade II urinary 
or rectal toxicity and none experiencing any higher grade toxicity. Late toxicity was also less in the recent 
study using rectal amifostine when compared to previously published studies. For instance, King et al. 
reported late grade II urinary toxicity in 24% of patients (33-month follow-up) compared to 2% for the 35 
Gy dose level (30-month follow-up) and 5.8% for the 36.25 Gy dose level (11-month follow-up). 
Regarding late bowel effects, King et al. observed 15% grade II toxicity at 33 month median follow-up. 
Katz et al. observed a late bowel toxicity rate of 4.2% for grade I toxicity and no higher grade toxicity for 
the 35 Gy dose level with 30 months of follow-up. They attribute their low bowel toxicity rate to the 
rectal administration of amifostine prior to SBRT delivery. (12, 16) Amifostine has been reported to 
significantly reduce the incidence of radiation-induced toxicity in multiple studies and when administered 
rectally has no related toxicity as opposed to intravenous administration which can cause significant 

6 
 
nausea. In both of these studies, late toxicity rates may increase with more follow-up, but what has been 
reported thus far is encouraging.  
Katz and colleagues also recently reported their preliminary experience with SBRT as a boost for 
73 intermediate and high risk prostate cancer patients after initial treatment with 45 Gy conventionally 
fractionated pelvic irradiation. The 3-fraction SBRT boost dose was escalated from 18 Gy to 19.5 Gy to 
21 Gy. After a median follow-up of 33 months, there were less than 7% grade 2 and no higher grade acute 
toxicities; one grade 3 late toxicity and no grade 4 late toxicities. Of the 97% of patients that had at least 2 
years of follow-up, 71.8% achieved a PSA nadir of 0.5 ng/mL. Three-year actuarial biochemical control 
rates were 89.5% and 77.7% for intermediate and high risk patients, respectively – 3 intermediate risk and 
7 high risk patients with biochemical failures. (17) 
The University of San Francisco (UCSF) recently published their results with SBRT both as 
monotherapy and as a boost treatment for prostate cancer. At the time of the study, 38 patients had been 
treated with a minimum follow-up of 12 months – 20 as monotherapy (9.5 Gy x 4 fractions) and 18 as a 
boost (9.5 Gy x 2 fractions) after external beam radiotherapy and androgen deprivation therapy. With a 
median follow-up of 18.3 months, 42% and 11% had acute grade 2 genitourinary and gastrointestinal 
toxicity, respectively, with no grade 3 or higher acute toxicity. Two patients experienced late grade 3 
genitourinary toxicity. All patients were free of biochemical or clinical recurrence at the time of follow-up 
with a median PSA nadir of 0.35 ng/mL. (18)  
The UCSF authors drew upon their experience with high dose rate (HDR) brachytherapy in which 
they were able to achieve similar dosimetry when compared with SBRT. Hypofractionation with HDR 
brachytherapy has demonstrated excellent efficacy and toxicity profiles as both monotherapy and after 
external beam radiotherapy as a boost for organ confined prostate cancer. The UCSF has recently reported 
its experience with HDR brachytherapy boost in mostly intermediate and high risk disease in which they 
achieved 5-year bNED (biochemical no evidence of disease) rates of 93% with minimal toxicity. (19) 
Superior bNED rates have also been reported in a randomized Phase III trial of HDR brachytherapy boost 
compared with external beam radiotherapy (EBRT) alone. (20) In addition, a systematic review of the 
literature recently concluded that the combination of EBRT and HDR brachytherapy results in superior 
bNED rates and overall survival when compared with EBRT alone or EBRT with a permanent prostate 
seed implant boost. (21) Grills and colleagues at William Beaumont Hospital have reported their HDR 
brachytherapy experience. Compared with permanent prostate seed implant with low dose rate palladium 
seeds, HDR brachytherapy was not only able to achieve equivalent biochemical control, but was also 
associated with decreased rates of acute and late toxicity and improved quality of life measures. (22) 
Using the HDR brachytherapy dose and fractionation, SBRT could theoretically achieve the excellent 
therapeutic profile of HDR brachytherapy while avoiding the risks of an invasive procedure and its 
inherent logistical challenges. 
SBRT for prostate cancer appears to be effective in controlling disease with acceptable toxicity. 
However, more studies are needed with longer term follow-up. St. John’s Mercy has installed an Elekta 
Synergy-S® linear accelerator at the David C. Pratt Cancer Center that is specifically designed to deliver 
highly-precise SBRT treatments.  It has a tightened isocenter accuracy calibrated to a precision of within 
1.5 mm diameter, a micro-MLC for treatment of small radiation ports, a specially designed Hexapod® 
table top that can correct for patient misalignment in both translational and rotational directions, an 
onboard cone-beam kV CT for precise tumor localization immediately prior to treatment, and four-
dimensional CT (4D-CT) which together allow for accurate monitoring of and compensation for tumor 
motion during respiration, active breathing control for respiratory gating, and real-time continuous 
fluoroscopic capability for visual confirmation that the target remains in the treatment field. 
 

7 
 
2.0 Objectives 
 
 
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic 
body radiotherapy (SBRT) for the treatment of organ confined prostate cancer. 
 
 
2.1 Hypothesis 
 
 
2.1.1 For selected patients with localized prostate cancer (clinical stage T1-2N0M0), 
stereotactic body radiotherapy (SBRT) is technically feasible with acceptable 
complication rates. 
 
 
2.1.2 Biochemical control with stereotactic body radiotherapy (SBRT) will be at least as good 
as standard fractionation radiation therapy 
 
 
2.2 Study Design 
 
 
2.2.1 Single site, non-randomized, prospective, phase IV trial 
  
2.2.2 Study group will include organ confined prostate cancer 
 
 
2.2.3 Data collected will include patient demographics, pathology data, tumor stage,  
 
 
 
SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,  
 
 
 
tumor recurrence data, and acute and late toxicities.   
 
 
2.2.4 Follow up data will be collected during the patient’s standard office visits.  The 
 
  
 
anticipated duration of this study is 5 years 
 
 
2.3 End Points 
 
 
2.3.1 Primary endpoints will be biochemical control rate   
-  Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular 
intervals 
 
 
 
-  The “Phoenix definition” for biochemical recurrence (nadir + 2 ng/ml) will be used 
 
 
2.3.2 Secondary endpoint will be late toxicity rate.  
 
 
 
- Grading of acute and late complications is defined in Section 12.3 (Appendix III)  
 
 
 
3.0 Patient Selection 
 
 
3.1 Eligibility Criteria 
 
 
3.1.1 
Patient age of at least 18 years 
 
 
3.1.2 
Zubrod performance status of 0-3 
 
 
3.1.3 
T1-3N0M0 adenocarcinoma of the prostate 
 
 
3.1.4 
Prostate volume ≤ 100 cc  
 
 
3.1.5 
No prior pelvic radiotherapy except as part of combination therapy for prostate cancer 
 
 
3.1.6 
Signed study-specific consent form 
 
 
3.2 Exclusion Criteria 
 
 
3.2.1 
Extension of local tumor to involve adjacent organs other than seminal vesicles (T4) 
 
 
3.2.2 
Prostate volume > 100 cc 
 
 
3.2.3 
Nodal involvement 
 
 
3.2.4 
Metastatic disease  
 
 
3.2.5 
Prior central pelvis radiotherapy except as part of combination therapy for prostate  
cancer 
 
 
3.2.6 
History of scleroderma 
 
 
3.2.7 
Patients with psychiatric or addictive disorder that would preclude obtaining informed  
 
 
 
consent 

8 
 
4.0 Pretreatment Evaluation 
 
4.1 Patient history, including prior radiation and chemotherapy treatments 
 
4.2 Physical examination including digital rectal examination 
 
4.3 Tissue biopsy confirming a diagnosis of malignancy  
 
4.4 Abdominopelvic CT scan or MRI as clinically indicated 
 
4.5 Bone scan and chest x-ray as clinically indicated 
 
4.6 CBC, platelets, bilirubin, albumin, AST, ALT, PT, PTT as clinically indicated 
 
5.0 Fiducial Placement 
 
5.1 Three gold fiducials will be placed within the prostate gland under ultrasound guidance in 
different locations 
 
5.2 Fiducials should be placed at least 7 days prior to simulation because of the possibility of 
migration 
 
6.0 Simulation 
 
6.1 
Bowel Prep on the morning of simulation including Dulcolax® laxative and a Fleet Enema. 
 
6.2 
Balloon catheter with 60 cc diluted barium contrast positioned in the rectum to stabilize pelvic 
anatomy 
 
6.3 
Custom body immobilization with the BodyFix system 
 
6.4 
CT simulation without IV contrast with 1-2 mm slice thickness, including at least 5 cm above 
and below the treatment volume. 
 
6.5 
3-point leveling tattoos 
 
6.6  Contrast enhanced MRI of the pelvis with 1-3 mm slice thickness (saline-filled 60 cc rectal 
balloon in place); CT-MRI fusion for target volume and normal tissue delineation 
 
7.0  Radiation Treatment Planning 
 
 
7.1 
Target Definition 
 
 
7.1.1 
Gross tumor volume (GTV) is contoured on the planning CT scan.  MRI images will 
be registered to the planning CT dataset to assist in constructing the GTV and normal 
structure volumes.  GTV will include the entire prostate gland. The proximal seminal 
vesicles may be included in the GTV at the discretion of the treating radiation 
oncologist based on high risk features (e.g. Gleason score > 6 and PSA > 15 ng/ml). 
GTVMR may be contoured to delineate the visible MR abnormality and may be 
targeted for an integrated boost at the discretion of the treating physician. 
 
 
7.1.2 
Clinical target volume (CTV) will be equal to the GTV  
 
 
7.1.3 
Planning target volume (PTV) will be defined as the CTV plus a 3-5 mm expansion 
margin throughout except posteriorly by the rectum where a 2-3 mm margin will be 
used.  For high risk patients with organ confined disease (e.g. Gleason score 8-10 
and/or PSA > 20 ng/ml), the PTV will also include a 5-8 mm margin on the involved 
side of the prostate. 
 
 
 
7.2 
Dose-Specification 
 
 
7.2.1 
The total prescription dose for SBRT will be 30 – 40 Gy in 4 – 5 fractions delivered 2 
to 3 times per week. The total prescription dose for SBRT as a boost after prior 
conventionally fractionated external beam pelvic radiotherapy (45 Gy in 25 fractions) 
will be 19 – 21 Gy in 2 – 3 fractions delivered 2 to 3 times per week. At the discretion 
of the treating radiation oncologist, an integrated boost of ~ 1 Gy per fraction may be 
directed at the MR abnormality. 

9 
 
 
 
7.2.2 
Radiation beams will conform to the PTV outline without additional margin and the 
dose will be prescribed to the isodose line (IDL) that covers at least 95% of the PTV. 
The 105% IDL should be confined to the PTV. 
 
 
7.2.3 
Conformality index (CI) = Prescription IDL volume / PTV volume 
 
 
 
 
 Goal = CI < 1.2 
 
 
7.2.4 
Gradient index (GI) = 50% Prescription IDL volume / Prescription IDL volume 
 
 
 
 
 Goal = GI < 3 
 
 
7.3 
Normal Tissue Dose Constraints 
 
 
7.3.1 
The normal structures that will be contoured using the planning CT/MR fusion are  
 
 
 
 
listed below with their respective dose constraints (five fractions) as derived from the  
 
 
 
 
available literature: 
 
STRUCTURE 
VOLUME 
DOSE 
Spinal Cord 
Dmax 
22.5 Gy  
< 10 cc 
20 Gy 
Cauda Equina 
Dmax 
27.5 Gy  
< 10 cc 
25 Gy 
Sacral Plexus 
Dmax 
30 Gy  
< 10 cc 
27.5 Gy 
Anterior Rectal Wall 
Dmax 
No more than 105% Rx 
Posterior Rectal Wall 
Dmax 
20 Gy 
Lateral Rectal Wall 
Dmax 
No more than 100% Rx 
< 3 cc cumulative 
(both sides) 
50 Gy 
Rectum superior to prostate 
Dmax 
30 Gy  
 
< 10 cc 
25 Gy  
Small Intestine 
Dmax 
30 Gy  
 
< 10 cc 
25 Gy 
Prostatic Urethra 
Dmax 
No more than 105% Rx 
Bladder 
Dmax 
No more than 105% Rx 
< 10 cc  
20 Gy 
Penile Bulb 
Dmax 
No more than 105% Rx 
< 3 cc  
30 Gy 
Femoral Heads 
< 10 cc cumulative 
(both sides) 
30 Gy 
Skin not within fold 
Dmax 
25 Gy 
Skin within fold (e.g. gluteal fold) 
Dmax 
20 Gy 
 
 
 
8.0 Stereotactic Body Radiotherapy Treatment Delivery 
 
 
8.1 
Premedication 
The decision to premedicate a patient prior to prostate SBRT is at the discretion of the treating 
radiation oncologist.  While there is no universal agreement, the following are a list of agents 
that have been suggested by some investigators to potentially reduce patient discomfort and 
possibly prevent acute and/or late toxicity if used as premedication prior to prostatic SBRT.  
 
 
8.1.1 
Corticosteroids (Decadron 4-10 mg PO or equivalent) 15-60 minutes prior to each 
fraction for the intended purpose of modulating immediate inflammatory effects.   
 
 
8.1.2 
Analgesic medication for patient comfort during long treatment duration. 
 
 
8.1.3 
Anti-anxiety medication for patient comfort during long treatment duration. 
 
 
8.1.4 
Tamsulosin (Flomax) starting on the first day of treatment and continuing for at least 3 
months 
 
 
8.1.5 
Bowel Prep on the morning of each treatment, including Dulcolax® laxative formula 
and a Fleet Enema.  The patient may also be asked to start a bowel regimen 3 days 

10 
 
prior to the simulation with Milk of Magnesia and Gas-X and continue throughout the 
course of treatment. 
 
 
8.1.6 
Amifostine 1500 mg mixed in saline and instilled into the rectum 20 minutes prior to 
each treatment 
 
 
8.2 
Treatment 
 
 
8.2.1 
The medical physics staff will perform routine quality assurance checks on the 
treatment machine to ensure that the mechanical isocenter stability is within 
specification (ie. diameter < 1.5 mm).  
 
 
8.2.2 
The medical physics staff will perform patient-specific quality assurance 
measurements to ensure that the treatment plan is deliverable and that the dose 
distribution is accurate.  
 
 
8.2.3 
The patient will be positioned in the custom immobilization device on the Hexapod® 
treatment couch and the rectal balloon will be inserted and filled with 60 cc of barium 
contrast. He will then be aligned to 3-point setup points with the in-room lasers. 
 
 
8.2.4 
Daily CT localization of the GTV isocenter is required prior to each fraction.  Once 
the patient is properly positioned, a cone-beam CT of the treatment area will be 
acquired, fused, and aligned to the treatment planning CT utilizing the patient’s 
internal anatomy, fiducial markers, and contrast-filled rectal balloon.  Translational 
and rotational adjustments of patient positioning are performed as indicated.  If 
adjustments are required, an orthogonal (ex. AP and LATERAL) set of electron portal 
images or a second cone-beam CT is then obtained prior to treatment to confirm 
proper alignment of the isocenter. 
 
 
8.2.5 
Either multiple coplanar or noncoplanar static gantry angle intensity-modulated fields 
or rotational arcs will be utilized. 
 
 
8.2.6 
Only photon (x-ray) beams will be used, preferably in energies of 6-18 MV.  
 
9.0 Drug Therapy 
 
9.1 
The use of hormone therapy is left to the discretion of the treating radiation oncologist and the 
patient’s urologist. 
 
9.2 
All forms of androgen suppression including neoadjuvant, concurrent, and adjuvant hormone 
therapy may be recommended. 
 
9.3 
Chemotherapy is rarely if ever used for localized prostate cancer but is left to the discretion of 
the medical oncologist. Chemotherapy is not allowed during SBRT.  Ideally, chemotherapy 
should not have been given within 30 days of starting radiation and should not resume until at 
least 2 weeks after completing radiation.  In addition, it is not recommended to perform SBRT 
when targeted anti-angiogenesis therapy is planned within 2 months of the procedure.  
 
10.0 Patient Assessment 
 
 
10.1 Study Parameters 
 
 
The following are suggested patient follow-up intervals and evaluations that may be  
 
 
performed to either assess for treatment toxicity or tumor response to SBRT: 
Assessment 
Pre-Rx Post-Rx 
6 wk 
Post-Rx  
3 mo 
Post-Rx 
6 mo 
Post-Rx 
9 mo 
Post-Rx 
1 yr 
H&P / Weight 
X 
X 
X 
X 
X 
Xb 
Disease status 
X 
X 
X 
X 
X 
Xb 
AUA/EPIC Questionnaire 
X 
X 
X 
X 
X 
X 
Toxicity Assessment 
 
X 
X 
X 
X 
Xb 
PSA 
X 
X 
X 
X 
X 
X 

11 
 
AST / ALT / Alk Phos 
Xa 
 
 
 
 
 
Total Bilirubin 
Xa 
 
 
 
 
 
PT / PTT 
Xa 
 
 
 
 
 
Creatinine  
Xa 
 
 
 
 
 
CBC with Platelets 
X 
 
 
 
 
 
Bone scan 
Xa 
 
 
 
 
 
CT/MR abdomen/pelvis 
X 
 
 
 
 
Xb 
 
 
 
a. if clinically appropriate  
 
 
 
b. at the discretion of the treating radiation oncologist 
 
 
10.2 Response Evaluation 
 
 
 
10.2.1 
Prostate Specific Antigen (PSA) 
- Will be obtained every 3 months for the first 2 years, then as indicated at the 
discretion of the treating physician. 
- Biochemical failure defined as nadir + 2 ng/ml 
- Repeat imaging including abdominopelvic CT scan, MRI, or bone scan as clinically 
indicated. 
 
 
10.3 Toxicity 
 
 
10.3.1 The patient will fill out the American Urological Association (AUA) Symptom Score 
Sheet and Expanded Prostate Cancer Index Composite (EPIC) questionnaire for 
gastrointestinal, urinary and sexual quality of life. (14) (Appendix IV and Appendix 
V, respectively) 
 
 
10.3.2 The investigator will report and record all serious adverse events that occur.  Adverse 
events should be reported using the CTC grading system (Appendix III).   
 
 
10.3.2 Examples of anticipated acute adverse events include: 
 
 
 
 
- General malaise 
- Urinary irritative or obstructive symptoms – dysuria, increased urinary 
frequency, nocturia, weak stream, hesitancy, and possible urinary retention 
- Rectal irritation – loose stools, cramping, straining, hemorrhoidal inflammation 
 
 
 
 
- Radiation dermatitis – dryness, tanning, redness, itching 
 
 
 
 
- Localized hair loss 
 
 
 
 
- Musculoskeletal pain 
 
 
10.3.3 Examples of anticipated late adverse events include:   
 
 
 
 
- Bleeding, ulceration and/or perforation of the bladder, rectum, or small bowel   
- Neurologic changes including motor weakness, numbness, paresthesias, and/or 
bowel or bladder dysfunction 
 
 
 
 
- Persistent changes in bowel or bladder habits 
 
 
 
 
- Small bowel obstruction 
 
 
 
 
- Urethral stricture resulting in urinary retention 
 
 
 
 
- Localized skin fibrosis, edema, and/or ulceration 
 
 
 
 
- Erectile dysfunction 
 
 
 
      - Radiation-induced secondary malignancy 
 
 
10.3.4 Reporting of unanticipated or serious adverse events will be reported according to the 
institutions IRB policy.  An unanticipated adverse event is defined as follows: 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, stereotactic body 
radiotherapy, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational 
plan or application (including a supplementary plan or application), or 

12 
 
any other unanticipated serious problem associated with a treatment that 
relates to the rights, safety, or welfare of subjects. 
  
 
10.4 Patient Withdrawal from Study 
During the course of the study, it is possible that patients may withdraw or be withdrawn from 
the study.  Factors that may lead to a withdrawal from the study may include, but are not 
limited to the following: 
 
 
 
Patient Withdrawal……………At any time a patient may voluntarily withdraw from the  
 
 
 
study.  This withdrawal will not affect their future medical  
 
 
 
 
 
 
treatment or benefits.   
 
 
 
Patient Lost to Follow-Up…….Should a patient be classified as lost to follow-up, efforts  
 
 
 
 
 
 
to contact the patient should be made.  
 
 
 
Physician Decision……………Should a physician decide that continuing in the study is  
 
 
 
 
 
 
detrimental to the health and welfare of the patient, the  
 
 
 
 
 
 
patient may be withdrawn from the study.   
 
 
 
Medical Reason……………….Should the patient condition deteriorate the patient may be  
 
 
 
 
 
 
withdrawn from the study to allow for proper medical care.   
11.0 Risk/Benefit Analysis 
 
 
11.1 Risk associated with SBRT for organ confined prostate cancer 
 
 
11.1.1 Acute toxicities reported to occur as a result of SBRT for prostate cancer include, but 
are not limited to:  general malaise, bowel/bladder irritation, local hair loss, and/or 
local musculoskeletal pain  
 
 
11.1.2 Late toxicities reported to occur as a result of SBRT for prostate cancer are primarily 
gastrointestinal including bleeding, ulceration, perforation, stenosis, and/or fistula and 
genitourinary including urethral stricture, bleeding, ulceration, and erectile 
dysfunction.  
 
 
11.2 Minimization of Risks 
Although the risks outlined in Section 10.3 may occur, the likelihood of serious events 
occurring is considered uncommon as long as certain precautions are taken.  The potential 
risks have been minimized by: 
 
 
- Premedication as described in Section 8.1, (e.g. rectal amifostine) 
 
 
- Improved rectal dose profile with rectal balloon 
 
 
- Strict compliance with normal tissue dose constraints as described in Sections 7.3 
 
 
11.3 Potential Patient Benefits 
 
 
11.3.1 Ability to offer effective and expedient local therapy  
 
 
11.3.2 Reduction in amount of radiation delivered to adjacent normal structures compared to  
 
 
 
standard-fractionation radiation therapy 
 
 
11.3.3 Significantly reduced treatment duration compared to standard-fractionation radiation  
 
 
 
therapy 
 
 
11.4 Justification of the Study 
 
 
 
For men diagnosed with localized prostate cancer, choosing between the various treatment 
options can be confusing and sometimes frustrating. For those who wish to avoid an invasive procedure, 
external beam radiotherapy which is fractionated daily over about two months has been the only 
alternative. Recent technological advances in stereotactic positioning of a patient for precise radiation 
delivery with online image guidance have led to a trend in radiation oncology of hypofractionation, which 
for the patient equals shorter treatment duration with the potential of equivalent or better tumor control 

13 
 
and toxicity rates. The use of hypofractionation in prostate cancer in particular is supported by its 
radiobiology; however, the proximity of adjacent organs at risk including the bladder and rectum has 
previously precluded its widespread adoption. When carefully administered, SBRT offers the potential to 
deliver the high doses necessary to control prostate cancer while sparing the adjacent structures in just 
five fractions. 
  
 
 
11.5 Statistical Analysis 
 
 
11.5.1 The overall survival and biochemical control rates will be analyzed. 
 
 
11.5.2 The incidence rate for any serious adverse events will be calculated. 
 
12.0 References 
 
1.  
Dasu A: Is the alpha/beta value for prostate tumours low enough to be safely used in clinical trials?. Clin 
Oncol (R Coll Radiol) 2007, 19(5):289-301. 
2. 
 
Potters L.  American Society for Therapeutic Radiology and Oncology and American College of  
 
 
Radiology practice guidelines for the performance of stereotactic body radiation therapy.  Int J  
 
 
Radiat Oncol Biol Phys.  60:1026-1032, 2004. 
3.  
Collins CD, Lloyd-Davies RW, Swan AV: Radical external beam radiotherapy for localised carcinoma of 
the prostate using a hypofractionation technique. Clin Oncol (R Coll Radiol) 1991, 3(3):127-132. 
4.  
Yeoh EE, Holloway RH, Fraser RJ, Botten RJ, Di Matteo AC, Butters J, Weerasinghe S, Abeysinghe P: 
Hypofractionated versus conventionally fractionated radiation therapy for prostate carcinoma: updated 
results of a phase III randomized trial. Int J Radiat Oncol Biol Phys 2006, 66(4):1072-1083. 
5.  
Lukka H, Hayter C, Julian JA, Warde P, Morris WJ, Gospodarowicz M, Levine M, Sathya J, Choo R, 
Prichard H, Brundage M, Kwan W: Randomized trial comparing two fractionation schedules for patients 
with localized prostate cancer. J Clin Oncol 2005, 23(25):6132-6138. 
6.  
Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A: Hypofractionated intensity-modulated 
radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int 
J Radiat Oncol Biol Phys 2007, 68(5):1424-1430. 
7.  
Livsey JE, Cowan RA, Wylie JP, Swindell R, Read G, Khoo VS, Logue JP: Hypofractionated conformal 
radiotherapy in carcinoma of the prostate: five-year outcome analysis. Int J Radiat Oncol Biol Phys 2003, 
57(5):1254-1259. 
8.  
Demanes DJ, Rodriguez RR, Schour L, Brandt D, Altieri G: High-dose-rate intensity-modulated 
brachytherapy with external beam radiotherapy for prostate cancer: California endocurietherapy’s 10-
year results. Int J Radiat Oncol Biol Phys 2005, 61(5):1306-1316. 
9.  
Martinez A, Gonzalez J, Spencer W, Gustafson G, Kestin L, Kearney D, Vicini FA: Conformal high dose 
rate brachytherapy improves biochemical control and cause specific survival in patients with prostate 
cancer and poor prognostic factors. J Urol 2003, 169(3):974-979, discussion 979-980. 
10. 
Tang CI, Loblaw DA, Cheung P, Holden L, Morton G, Basran PS, Tirona R, Cardoso M, Pang G, Gardner 
S, Cesta A. Phase I/II study of a five-fraction hypofractionated accelerated radiotherapy treatment for low-
risk localised prostate cancer: Early results of pHART3. Clin Oncol (R Coll Radiol), 20(10):729-737, 
2008. 
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, 67(4):1099-1105, 2007. 
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 2009, 73(4):1043-1048. 
13. 
Wiegner EA, King CR. Sexual function after stereotactic body radiotherapy for prostate cancer: Results of 
a prospective clinical trial. Int J Radiat Oncol Biol Phys, 78(2):442-8, 2010. 
14. 
Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG: Development and validation of the expanded 
prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in 
men with prostate cancer. Urology 2000, 56(6):899-905.  
15. 
Boike TP, Lotan Y, Cho LC, Brindle J, Perkins A, Abdulrahman R, Pistenmaa D, Timmerman R. A phase I 
dose-escalation study of stereotactic body radiation therapy (SBRT) for low- and intermediate-risk prostate 
cancer. American Society of Clinical Oncology (ASCO) 2010 Genitourinary Cancers Symposium.  

14 
 
16.  
Katz AJ, Santoro M, Ashley R, Diblasio F, Witten M. Stereotactic body radiotherapy for organ-confined 
prostate cancer. BMC Urol. 2010 Feb 1;10:1. 
17. 
Katz AJ, Santoro M, Ashley R, Diblasio F, Witten M. Stereotactic body radiotherapy as boost for organ-
confined prostate cancer. Technol Cancer Res Treat. 2010 Dec;9(6):575-82. 
18. 
Jabbari S, Weinberg VK, Kaprealian T, Hsu IC, Ma L, Chuang C, Descovich M, Shiao S, Shinohara K, 
Roach M, Gottschalk AR. Stereotactic Body Radiotherapy as Monotherapy or Post-External Beam 
Radiotherapy Boost for Prostate Cancer: Technique, early Toxicity, and PSA Response. Int J Radiat Oncol 
Biol Phys, 78(2):442-8, 2010. 2010 Dec 21. [Epub ahead of print] 
19. 
Kaprealian T, Weinberg V, Speight J, et al. High dose rate brachytherapy boost for prostate cancer: 
Comparison of two different fractionation schemes. Paper presented at the 2008 Annual Meeting of the 
American Society of Radiation Oncology (ASTRO); November 2008, Boston, MA. 
20. 
P.J. Hoskin, K. Motohashi and P. Bownes et al., High dose rate brachytherapy in combination with 
external beam radiotherapy in the radical treatment of prostate cancer: Initial results of a randomised 
phase three trial, Radiother Oncol 84 (2007), pp. 114–120. 
21. 
B.R. Pieters, D.Z. de Back, C.C. Koning and A.H. Zwinderman, Comparison of three radiotherapy 
modalities on biochemical control and overall survival for the treatment of prostate cancer: A systematic 
review, Radiother Oncol 93 (2009), pp. 168–173. 
22. 
I.S. Grills, A.A. Martinez and M. Hollander et al., High dose rate brachytherapy as prostate cancer 
monotherapy reduces toxicity compared to low dose rate palladium seeds, J Urol 171 (2004), pp. 1098–
1104. 

15 
 
13.0 Appendices 
 
 
13.1 Appendix I 
 
St. John’s Mercy Medical Center 
Informed Consent for a Clinical Research Study 
 
STUDY TITLE: 
PHASE II TRIAL EVALUATING THE USE OF STEREOTACTIC BODY  
RADIOTHERAPY FOR THE TREATMENT OF PROSTATE CANCER 
 
This is a clinical trial (type of research study).  Clinical trials include only patients who choose to take 
part.  This consent form may contain words that you do not understand.  Please ask the study doctor or the 
study staff to explain any words or information that you do not clearly understand.  You may take home 
an unsigned copy of this consent form to think about or discuss with family and friends before making 
your decision.   
 
WHAT SHOULD YOU KNOW ABOUT THE RESEARCH DOCTOR? 
 
You should know that your relationship with a research doctor is different from your relationship with 
your personal doctor.  Your personal doctor is treating your specific problem with the hope of a benefit 
for you.  When a doctor is your research doctor, he/she is treating all subjects under a specific protocol to 
learn about the results of a treatment, and with the understanding that you may or may not benefit from 
your participation in the study.  Be sure to ask questions of the study doctor if you want more information 
about this relationship. 
 
The Radiation Oncologists of this study are part owner of the radiosurgery treatment equipment. 
The Radiation Oncologists will receive financial compensation when the equipment is used in 
addition to the professional fee normally charged. 
 
WHY IS THIS STUDY BEING PERFORMED? 
 
For men diagnosed with prostate cancer, choosing between the various treatment options can be 
confusing and sometimes frustrating. Some men wish to avoid an invasive procedure such as surgical 
removal of the prostate or implantation of radioactive seeds. In that case, external beam radiotherapy 
which is administered daily over about two months has been the only alternative. Recent technological 
advances in positioning the patient for precise radiation delivery using sophisticated computers have led 
to a new concept of hypofractionation, or fewer radiation treatments given at a higher dose per day.    
This new technique is called stereotactic body radiotherapy (SBRT), which means the precise delivery 
of high-dose radiation in 5 or fewer treatments.  SBRT allows shorter overall treatment duration with the 
potential of equivalent or better tumor control and side effects compared to standard fractionation. The 
use of SBRT in prostate cancer in particular is supported by its sensitivity to radiation; however, the risk 
of damaging nearby organs including the bladder and rectum has previously prevented its widespread use. 
When carefully administered, SBRT offers the potential to deliver the high doses necessary to control 
prostate cancer while sparing the nearby structures in just five fractions. The purpose of this study is to 
collect additional data on the effectiveness of stereotactic body radiotherapy for prostate cancer.   
 
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY? 
 
Approximately 100 people are expected to participate in this clinical study. 
 

16 
 
WHAT IS INVOLVED IN THE STUDY? 
 
If you wish to take part in this study, a series of tests will be performed to determine if you qualify for 
participation in the clinical study.  Your physician will ask you a series of questions regarding your 
medical history and a standard physical exam will be performed.   
 
If you qualify for the study, you may first have at least 3 gold markers placed into the prostate by a 
diagnostic radiologist to help locate your tumor during radiation treatment.  Next, you will undergo a 
radiation treatment planning session called a simulation.  At this visit, a custom rigid foam device will be 
fabricated to immobilize your body in the correct position for treatment.  A deflated rectal balloon 
catheter will be inserted into the rectum and inflated. A CT scan and an MRI scan of your pelvis will be 
obtained to plan your treatment. Permanent small tattoos may be applied to your skin to aid in positioning 
your body on the treatment table. 
 
There may be several days between the simulation and the day you begin radiation.  During this time, 
complex radiation treatment planning will be performed by your radiation oncologist and their medical 
physics staff.  If your radiation oncologist recommends SBRT alone, you will receive 4 or 5 radiation 
treatments.  Based on an assessment of high risk features, your physician may recommend a 5 week 
course of daily radiation therapy directed at your pelvis prior to administering 2 or 3 SBRT treatments 
directed at the prostate. Your physician will explain your treatment in more detail.  Each radiation session 
may take an hour or longer to complete.  After the entire radiation course is complete, you will be given 
follow-up instructions.   You will be asked to fill out a confidential questionnaire at various time points 
after your treatment. Your honest answers to these questions will help the investigators to better 
understand the changes to your quality of life from this treatment.  
 
HOW LONG WILL I BE IN THE STUDY? 
 
We anticipate that you will remain in the study for approximately 5 years.  After treatment is completed 
routine follow-up visits will be conducted, typically at 3 month intervals for the first 2 years, then less 
frequently. 
 
Your physician may decide stop your treatment if: 1) your disease becomes worse, or 2) side effects 
become very severe, or 3) new scientific developments occur that indicate the treatment is not in your best 
interest, or 4) your physician believes that this treatment is no longer in your best interest.  If your 
treatment is stopped, your doctor will discuss further treatment options with you.  
 
WHAT ARE THE RISKS OF THE STUDY? 
 
By participating in this study, you are at risk for several possible expected and unexpected side effects 
associated with stereotactic radiotherapy to the prostate.  Some of these are described below; however, 
there also may be other side effects that we cannot predict.  Most side effects go away shortly after the 
radiation therapy is stopped, but in some cases side effects can be serious, long-lasting, or permanent.  
 
Risks arising from the delivery of stereotactic radiotherapy to the prostate which may occur shortly after 
completing treatment may include, but are not limited to:  
 
• 
Generalized fatigue 
 
• 
Diarrhea 
 
• 
Rectal irritation 
 
• 
Bladder irritation – urinary frequency, urgency, burning, slow stream 
 
• 
Hair loss over the treatment area 
 
• 
Skin irritation – redness, tanning, dryness, peeling, soreness, itchiness over the treatment area 

17 
 
 
• 
Temporary decrease in sperm count and gene mutation – take precautions not to conceive 
children during course of radiation treatment and for at least 12 months after completing therapy 
 
• 
Muscular pain over the treatment area 
 
Risks arising from the delivery of stereotactic radiotherapy to the prostate which may develop several 
months to years after completing treatment may include, but are not limited to:  
 
• 
Bleeding ulceration and/or perforation (hole) in the bladder, rectum, and/or small bowel 
 
• 
Chronic changes in bowel or bladder habits 
 
• 
Erectile dysfunction  
 
• 
Sterility  
 
• 
Urethral stricture – possibly causing urinary retention which may require temporary placement of 
a catheter 
 
• 
Injury to bones in the pelvis 
 
• 
Radiation-induced cancer 
 
I understand that all these side effects are possible.  I may experience no side effects, some of them, or 
most of them.  Although I will be closely monitored, not all side effects can be predicated and unforeseen 
problems can arise.  I understand that there may be some unknown or unanticipated risks or discomforts 
in addition to those specified here. 
 
Reproductive risks: 
You should not father a baby during radiation and for 6 months after completing your radiation 
treatments, because the radiation can affect an unborn baby.  It is important that you understand that you 
need to use birth control while on this study.  Check with your study doctor about what kind of birth 
control methods to use and how long to use them.  Ask about counseling and more information about 
preventing pregnancy. 
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
 
If you agree to take part in this study, there may or may not be a direct medical benefit to you.  However, 
there have been several trials completed at other institutions that have shown similar control rates after 
stereotactic body radiotherapy as that found with standard treatment for prostate cancer.  It is also 
convenient, requiring only 5 radiation sessions and no anesthesia or hospitalization.  Toxicity risk has 
been reported to be fairly low. 
 
WHAT OTHER OPTIONS ARE THERE? 
 
Other treatment options may include surgery, standard-fractionation radiation therapy, permanent seed 
brachytherapy, or other investigational procedures.  Your doctor can provide information about your 
disease and the benefits of the different treatments for you.  You should feel free to talk with your doctor 
about your disease and expected outcomes.  The doctor involved in your care will be available to answer 
any questions you have about this program.  You are free to ask your doctor any questions concerning this 
program now or in the future.  
 
You are free to seek care from a doctor of your choice at any time.  If you do not take part in, or withdraw 
from, the study you will continue to receive alternate care.   
 
WHAT ABOUT CONFIDENTIALITY? 
 
Efforts will be made to keep your personal information confidential.  We cannot guarantee absolute 
confidentiality.  This Informed Consent and another document called an “Authorization to Use and 

18 
 
Disclose Health Information” control how your health information may be used and disclosed during and 
after this study.  The results of this study may be published or presented at meetings but will not include 
your name or reveal your identity.  To participate in this study, you must sign both the Informed Consent 
and the Authorization to Use and Disclose Health Information.  Your personal information may be 
disclosed if required by law. 
 
WHAT ARE THE COSTS? 
 
Taking part in this study may lead to added costs to you or your insurance carrier.  Specifically, you or 
your insurance carrier will be responsible for the costs of the baseline blood tests, diagnostic imaging 
studies, stereotactic radiotherapy planning and delivery, and follow-up visits which would otherwise be a 
standard part of your care.  Please ask about any expected added costs or insurance problems.  St. John’s 
Mercy Medical Center has personnel that can assist you with this.   
 
Every precaution will be taken to prevent any injury to you during the study. In the event that injury 
occurs as a result of this study, treatment will be available.  You or your insurance carrier will be 
responsible for the costs of the treatment.  No funds have been set aside for compensation in the event of 
a research related injury.   
 
You or your insurance company will be charged for continuing medical care and/or hospitalization.   
 
You will not receive payment for participating in this study.   
 
WHAT ARE MY RIGHTS AS A PARTICIPANT? 
 
Your participation is voluntary.  You may choose not to take part or may leave the study at any time.  
Your choice will not affect your doctors from providing care to you.  Choosing not to participate or 
leaving the study will not result in any penalty or loss of benefits to which you are entitled. 
 
You will be told of any important new findings developed during the course of your participation in this 
study that may affect your willingness to continue in the study.  The investigator may withdraw you from 
this study if issues occur that show that you should not continue to participate. 
 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?    
 
If you have any questions or concerns regarding this study, or a research-related injury, you may contact 
one of the Principal Investigators, Dr. Jaymeson Stroud at 314-251-6844 or Dr. Bethany Sleckman at 
314-251-5665. 
 
For questions about your rights as a research participant, contact Dr. Donald York, Chairman of the St. 
John’s Mercy Medical Center Institutional Review Board (which is a group of people who review the 
research to protect your rights), at 314-569-6453. 
 
Your doctor understands the importance of your contribution to clinical studies that attempt to improve 
medical care.  Your doctor will make every effort to minimize, control, and treat any problems that may 
happen as a result of your participation in this study.  If you believe that you are injured solely as a result 
of the study, or if you have questions regarding the study, please contact the Principal Investigator. 
 
WHERE CAN I GET MORE INFORMATION? 
 
You may call the NCI’s Cancer Information Service at 1-800-422-6237 or TTY:1-800-322-8615 

19 
 
 
Visit the NCI’s Web Sites: 
• 
Cancer Trials: comprehensive clinical trials information 
 
http://cancertrials.nci.nih.gov 
• 
CancerNet: accurate cancer information including PDQ 
 
http://cancernet.nci.nih.gov 
 
SIGNATURES 
 
I have read all the above, asked questions, and received answers concerning areas I did not understand.  I 
have had the opportunity to take this consent form home for review or discussion.  I willingly give my 
consent to participate in this study.  Upon signing this form I will receive a copy.  I may also request a 
copy of the protocol (full study plan). 
 
Participant (sign) ______________________________________________________________ 
 
Participant (written) ___________________________________________________________ 
 
Date _________________________________________________________________________ 
 
Principal Investigator ___________________________________________________________ 
 
Staff Member Performing Consent Process _________________________________________ 
 
Witness _______________________________________________________________________ 
 
IRB Stamp (This form is INVALID if the stamp is not present.) 

20 
 
 
13.2 Appendix II  
 
 
KARNOFSKY PERFORMANCE SCALE 
 
 
 
100 
Normal; no complaints; no evidence of disease 
 
 
 
90 
Able to carry on normal activity; minor signs or symptoms of disease 
 
 
 
80 
Normal activity with effort; some signs or symptoms of disease 
 
 
 
70 
Cares for self; unable to carry on normal activity or do active work 
 
 
 
60 
Requires occasional assistance, but is able to care for most personal needs 
 
 
 
50 
Requires considerable assistance and frequent medical care 
 
 
 
40 
Disabled; requires special care and assistance 
 
 
 
30 
Severely disabled; hospitalization is indicated, although death not imminent 
 
 
 
20 
Very sick; hospitalization necessary; active support treatment is necessary 
 
 
 
10 
Moribund; fatal processes progressing rapidly 
 
 
 
0 
Dead 
 
 
 
ZUBROD PERFORMANCE SCALE 
 
 
 
0 
Fully active, able to carry on all pre-disease activities without restriction 
 
 
 
(KPS 90-100) 
 
 
 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out  
 
 
 
work of a light or sedentary nature.  For example, light housework, office work 
 
 
 
(KPS 70-80) 
 
 
 
2 
Ambulatory and capable or all self-care but unable to carry out any work  
 
 
 
activities.  Up and about more than 50% of waking hours  
 
 
 
(KPS 50-60) 
 
 
 
3 
Capable of only limited self-care, confined to bed or chair 50% of more of  
 
 
 
waking hours 
 
 
 
(KPS 30-40) 
 
 
 
4 
Completely disabled.  Cannot carry on any self-care.  Totally confined to bed or  
 
 
 
chair 
 
 
 
(KPS 10-20) 
 
 

21 
 
13.3 
Appendix  III 
 
Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 
 
 
GRADE 
Toxicity 
1 
2 
3 
4 
5 
 
CONSTITUTIONAL 
 
 
 
 
 
 
Fatigue 
Mild fatigue over 
baseline 
Moderate or causing 
difficulty performing 
some ADL 
Severe fatigue interfering 
with ADL 
Disabling 
- 
Fever 
100.4-102.2°F 
102.3-104.0°F 
> 104.0°F for < 24 hr 
> 104.0°F for > 24 hr 
Death 
Weight loss 
5 - < 10% of 
baseline 
10 - < 20% of 
baseline 
> 20% of baseline; tube 
feeding or TPN indicated 
- 
- 
 
PAIN 
 
 
 
 
 
 
Pain due to radiation 
Mild pain not 
interfering with 
function 
Moderate pain: pain 
or analgesics 
interfering with 
function, but not 
interfering with ADL 
Severe pain: pain or 
analgesics severely 
interfering with ADL 
Disabling 
- 
Myositis (inflammation or 
damage of muscle) 
Mild pain not 
interfering with 
function 
Pain interfering with 
function, but not 
interfering with ADL 
Pain interfering with ADL 
Disabling 
Death 
 
SKIN 
 
 
 
 
 
 
Radiation dermatitis 
Faint erythema or 
dry desquamation 
Moderate to brisk 
erythema; patchy 
moist desquamation, 
mostly confined to 
skin folds and 
creases; moderate 
edema 
Moist desquamation other 
that skin folds and creases; 
bleeding induced by minor 
trauma or abrasion 
Skin necrosis or ulceration 
of full thickness dermis; 
spontaneous bleeding from 
involved site 
 
Telangiectasia 
Few 
Moderate number 
Many and confluent 
- 
- 
Ulceration 
- 
Superficial ulceration  
< 2 cm size; local 
wound care; medical 
intervention indicated 
Ulceration > 2 cm size; 
operative debridement, 
primary closure or other 
invasive intervention 
indicated (ex. Hyperbaric 
oxygen) 
Life-threatening 
consequences; major 
invasive intervention (ex. 
Complete resection, tissue 
reconstruction, flap, 
grafting) 
Death 
Fibrosis 
Increased density, 
“spongy” feel 
Increased density with 
firmness or tethering 
Increased density with 
fixation of tissue; operative 
intervention indicated; 
interfering with ADL 
Life-threatening; disability; 
loss of limb; interfering 
with vital organ function 
Death 
Soft Tissue Necrosis 
- 
Local wound care; 
medical intervention 
indicated 
Operative debridement or 
other invasive intervention 
indicated (ex. Hyperbaric 
oxygen) 
Life-threatening 
consequences; major 
invasive intervention 
indicated (ex. Tissue 
reconstruction, flap, or 
grafting) 
Death 
 
NEUROLOGY 
 
 
 
 
 
 
Neuropathy:  Motor 
Asymptomatic, 
weakness on 
exam/testing only 
Symptomatic 
weakness interfering 
with function, but not 
interfering with ADL 
Weakness interfering with 
ADL; bracing or assistance 
to walk (e.g. cane or 
walker) indicated 
Life-threatening; disabling 
(e.g. paralysis) 
Death 
Neuropathy:  Sensory 
Asymptomatic, lost 
deep tendon reflexes 
or paresthesia 
(including tingling), 
not interfering with 
function 
Symptomatic 
alteration or 
paresthesia (including 
tingling), interfering 
with function, not 
interfering with ADL 
 
Sensory alteration or 
paresthesia interfering with 
ADL 
Disabling 
Death 

22 
 
 
GI TRACT 
 
 
 
 
 
 
Nausea 
Loss of appetite 
without alteration in 
eating habits 
Oral intake decreased 
without significant 
weight loss, 
dehydration, or 
malnutrition; IV 
fluids indicated < 24 
hr 
Inadequate oral caloric or 
fluid intake; IV fluids, tube 
feedings, or TPN indicated 
> 24 hr 
Life-threatening 
consequences 
Death 
Vomiting 
1 episode in 24 hr 
2-5 episodes in 24 hr; 
IV fluids indicated < 
24 hr 
> 6 episodes in 24 hr; IV 
fluids or TPN indicated > 
24 hr 
Life-threatening 
consequences 
Death 
Diarrhea 
Increase of < 4 stools 
per day over 
baseline; mild 
increase in ostomy 
output compared to 
baseline 
Increase of 4-6 stools 
per day over baseline; 
IV fluids indicated < 
24 hrs; moderate 
increase in ostomy 
output compared to 
baseline; not 
interfering with ADL 
Increase of > 7 stools per 
day over baseline; IV fluids 
indicated > 24 hrs; 
hospitalization; severe 
increase in ostomy output 
compared to baseline; 
interfering with ADL 
Life-threatening 
consequences (e.g., 
hemodynamic collapse) 
Death 
Enteritis 
Asymptomatic, 
pathologic or 
radiographic 
findings only 
Abdominal pain; 
mucous or blood in 
stool 
Abdominal pain, fever, 
change in bowel habits with 
ileus; peritoneal signs 
Life-threatening 
consequences (ex. 
Perforation, bleeding, 
ischemia, necrosis) 
Death 
Ulceration 
Asymptomatic, 
radiographic or 
endoscopic findings 
only 
Symptomatic; altered 
GI function (altered 
dietary habits, oral 
supplements); IV 
fluids indicated < 24 
hr 
Symptomatic and severely 
altered GI function 
(inadequate oral caloric or 
fluid intake); IV fluids, tube 
feedings, or TPN indicated 
> 24 hr 
Life-threatening 
consequences 
Death 
Bleeding 
Mild, intervention 
(other than iron 
supplements) not 
indicated 
Symptomatic and 
medical intervention 
or minor cauterization 
indicated  
Transfusion, interventional 
radiology, endoscopic, or 
operative intervention 
indicated 
Life-threatening 
consequences; major urgent 
intervention indicated 
Death 
Perforation 
Asymptomatic 
radiographic 
findings only 
Medical intervention 
indicated; IV fluids 
indicated < 24 hr 
IV fluids, tube feedings, or 
TPN indicated > 24 hr; 
operative intervention 
indicated 
Life-threatening 
consequences 
Death 
Stricture 
Asymptomatic 
radiographic 
findings only 
Symptomatic; altered 
GI function (altered 
dietary habits, 
vomiting, bleeding, 
diarrhea); IV fluids 
indicated < 24 hr 
Symptomatic and severely 
altered GI function (altered 
dietary habits, diarrhea, or 
GI fluid loss); IV fluids, 
tube feedings, or TPN 
indicated > 24 hr; operative 
intervention indicated 
Life-threatening 
consequences; operative 
intervention requiring 
complete organ resection 
Death 
Fistula 
Asymptomatic; 
radiographic 
findings only 
Symptomatic; altered 
GI function (ex. 
Altered dietary habits, 
diarrhea, or GI fluid 
loss); IV fluids 
indicated < 24 hr 
Symptomatic and severely 
altered GI function (ex. 
Altered dietary habits, 
diarrhea, or GI fluid loss); 
IV fluids, tube feedings, or 
TPN indicated > 24 hr 
Life-threatening 
consequences 
Death 
 
GENITOURINARY 
 
 
 
 
 
 
Bladder spasms 
Symptomatic, 
intervention 
not indicated 
Symptomatic, 
antispasmodics 
indicated 
Narcotics indicated 
Major surgical 
intervention indicated 
(e.g., cystectomy) 
 
Cystitis 
Asymptomatic 
Frequency with 
dysuria; 
macroscopic 
hematuria 
Transfusion; IV pain 
medications; bladder 
irrigation indicated 
Catastrophic bleeding; 
major non-elective 
intervention indicated 
Death 
Fistula 
Asymptomatic; 
radiographic 
findings only 
Symptomatic; 
noninvasive 
intervention 
indicated 
Symptomatic interfering 
with ADL; invasive 
intervention indicated 
Life-threatening 
consequences; operative 
intervention requiring 
partial or full organ 
resection; permanent 
urinary diversion 
Death 
Incontinence, urinary 
Occasional (e.g., 
Spontaneous, pads 
Interfering with ADL; 
Operative intervention 
- 

23 
 
with 
coughing, sneezing, 
etc.), 
pads not indicated 
indicated 
intervention indicated 
(e.g., clamp, collagen 
injections) 
indicated (e.g., 
cystectomy or permanent 
urinary diversion) 
Urinary 
frequency/urgency 
Increase in 
frequency or 
nocturia up to 2 x 
normal; 
enuresis 
Increase >2 x normal 
but 
<hourly 
≥1 x/hr; urgency; catheter 
indicated 
- 
- 
Urinary retention 
Hesitancy or 
dribbling, no 
significant residual 
urine; 
retention occurring 
during 
the immediate 
postoperative period 
Hesitancy requiring 
medication; or 
operative 
bladder atony 
requiring 
indwelling catheter 
beyond immediate 
postoperative period 
but 
for <6 weeks 
More than daily 
catheterization indicated; 
urological intervention 
indicated (e.g., TURP, 
suprapubic tube, 
urethrotomy) 
Life-threatening 
consequences; organ 
failure (e.g., bladder 
rupture); operative 
intervention requiring 
organ resection indicated 
Death 
Stricture, GU 
Asymptomatic, 
radiographic or 
endoscopic findings 
only 
Symptomatic but no 
hydronephrosis, 
sepsis or 
renal dysfunction; 
dilation 
or endoscopic repair 
or 
stent placement 
indicated 
Symptomatic and altered 
organ function (e.g., 
sepsis or hydronephrosis, 
or renal dysfunction); 
operative intervention 
indicated 
Life-threatening 
consequences; organ 
failure or operative 
intervention requiring 
organ resection indicated 
Death 
 
MUSCULOSKELETAL 
 
 
 
 
 
 
Fracture 
Asymptomatic, 
radiographic 
findings only  
Symptomatic but non-
displaced; 
immobilization 
indicated 
Symptomatic and 
displaced; operative 
intervention indicated 
Disabling 
Death 
 
METABOLIC 
 
 
 
 
 
 
Albumin 
3-4 g/dL 
2-2.99 g/dL 
< 2 g/dL 
 
Death 
Alkaline phosphatase 
> nl – 2.5 x nl 
> 2.5 – 5 x nl 
 > 5 – 20 x nl 
> 20 x nl 
- 
ALT 
> nl – 2.5 x nl 
> 2.5 – 5 x nl 
 > 5 – 20 x nl 
> 20 x nl 
- 
AST 
> nl – 2.5 x nl 
> 2.5 – 5 x nl 
 > 5 – 20 x nl 
> 20 x nl 
- 
Bilirubin 
> nl – 1.5 x nl 
> 1.5 – 3 x nl 
> 3 – 10 x nl 
> 10 x nl 
- 
Creatinine 
> nl – 1.5 x nl 
> 1.5 – 3 x nl 
> 3 – 6 x nl 
> 6 x nl 
Death 
 
SECONDARY 
MALIGNANCY 
 
- 
- 
Non-life-threatening basal 
or squamous cell carcinoma 
of the skin 
Solid tumor, leukemia, or 
lymphoma 
Death 
 

24 
 
 
13.4   Appendix  IV    ON-STUDY AUA SYMPTOM SCORE  
 
 
PLEASE FILL OUT THIS SHORT QUESTIONNAIRE TO HELP US FIND OUT MORE ABOUT 
ANY URINARY PROBLEMS YOU MIGHT HAVE. CIRCLE A NUMBER IN EACH COLUMN 
THAT BEST DESCRIBES YOUR SITUATION. YOU MUST ANSWER ALL QUESTIONS. 
 
Not at all Less than 
one time 
in five 
Less than 
half the 
time 
About 
half the 
time 
More 
than half 
the time 
Almost 
always 
1. Over the past month or so, 
how often have you had a 
sensation of not emptying 
your bladder completely 
after you finished urinating? 
0 
1 
2 
3 
4 
5 
2. Over the past month or so, 
how often have you had to 
urinate again, less than two 
hours after you finished 
urinating? 
0 
1 
2 
3 
4 
5 
3. Over the past month or so, 
how often have you found 
you stopped and started 
again several times when 
you urinated? 
0 
1 
2 
3 
4 
5 
4. How often do you find it 
difficult to postpone 
urination? 
0 
1 
2 
3 
4 
5 
5. Over the past month or so, 
how often have you had a 
weak urinary stream? 
0 
1 
2 
3 
4 
5 
6. Over the past month or so, 
how often have you had to 
push or strain to begin 
urination? 
0 
1 
2 
3 
4 
5 
  
Not at all 
Once 
every 8 
hours 
Once 
every 4 
hours 
Once 
every 3 
hours 
Once 
every 2 
hours 
At least 
once every 
hour 
7. Over the past month or so, 
how often did you most 
typically get up at night to 
urinate? 
0 
1 
2 
3 
4 
5 
 
  Total per column 
______ 
______ 
______ 
______ 
______ 
______ 
  ______________________    _______________________ 
_________________________ 
  Patient Name                           Patient Signature 
Date This Form was Completed 

25 
 
13.5  Appendix V 
 
 
EPIC 
 
The Expanded Prostate Cancer Index Composite 
 
This questionnaire is designed to measure Quality of Life issues in patients with Prostate cancer. 
To help us get the most accurate measurement, it is important that you answer all questions 
honestly and completely. 
 
Remember, as with all medical records, information contained within this survey will remain 
strictly confidential. 
 
 
 
Today's Date (please enter date when survey completed): 
Month________Day________Year________ 
 
Name (optional): _________________________________________________ 
 
Date of Birth (optional): Month__________Day___________Year__________ 
 
URINARY FUNCTION 
 
This section is about your urinary habits. Please consider ONLY THE LAST 4 
WEEKS. 
 
1. Over the past 4 weeks, how often have you leaked urine? 
 
More than once a day...................... 1  
 
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
2. Over the past 4 weeks, how often have you urinated blood? 
 
More than once a day...................... 1  
 

26 
 
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
3. Over the past 4 weeks, how often have you had pain or burning with urination?  
 
More than once a day...................... 1  
 
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
4. Which of the following best describes your urinary control during the last 4 weeks? 
 
No urinary control 
whatsoever..................................................1 
 
 
 
Frequent dribbling...................................... 2 
(Circle one number) 
 
 
Occasional dribbling.................................. 3 
 
 
Total control............................................... 4 
 
 
 
5. How many pads or adult diapers per day did you usually use to control leakage during the 
last 4 weeks? 
 
None........................................................ 0 
 
 
 
1 pad per day........................................…1 
 
 
2 pads per day.......................................... 2 
(Circle one number) 
 
 
3 or more pads per day............................ 3 
 
 
 
 
6. How big a problem, if any, has each of the following been for you during the last 4 weeks? 
(Circle one number on each line) 
No 
Problem
Very 
Small 
Problem 
Small 
Problem 
Moderate
Problem 
Big 
Problem 
a. Dripping or leaking urine …...... 
0 
1 
2 
3 
4 
 
b. Pain or burning on urination..... 
0 
1 
2 
3 
4 
 
c. Bleeding with urination............. 
0 
1 
2 
3 
4 
 
d. Weak urine stream or incomplete 
emptying……….. 
0 
1 
2 
3 
4 
 

27 
 
e. Waking up to urinate………….. 
0 
1 
2 
3 
4 
 
f. Need to urinate frequently during 
the day ………………………….. 
0 
1 
2 
3 
4 
 
 
 
7. Overall, how big a problem has your urinary function been for you during the last 4 weeks? 
 
No problem..................................... 1  
 
 
Very small problem......................... 2  
 
Small problem................................. 3 (Circle one number) 
 
 
Moderate problem........................... 4  
 
Big problem..................................... 5  
 
BOWEL HABITS 
 
The next section is about your bowel habits and abdominal pain.  
Please consider ONLY THE LAST 4 WEEKS. 
 
 
8. How often have you had rectal urgency (felt like I had to pass stool, but did not) during the 
last 4 weeks? 
 
More than once a day...................... 1  
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
9. How often have you had uncontrolled leakage of stool or feces? 
 
More than once a day...................... 1  
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
10. How often have you had stools (bowel movements) that were loose or liquid (no form, 
watery, mushy) during the last 4 weeks? 

28 
 
 
Never............................................... 1  
 
Rarely.............................................. 2  
 
About half the time.......................... 3 (Circle one number) 
 
Usually............................................. 4  
 
Always.............................................. 5  
 
 
11. How often have you had bloody stools during the last 4 weeks? 
 
Never............................................... 1  
 
Rarely.............................................. 2  
 
About half the time.......................... 3 (Circle one number) 
 
Usually............................................. 4  
 
Always............................................. 5  
 
 
12. How often have your bowel movements been painful during the last 4 weeks? 
 
Never............................................... 1  
 
Rarely.............................................. 2  
 
About half the time.......................... 3 (Circle one number) 
 
Usually............................................. 4  
 
Always............................................. 5  
 
 
13. How many bowel movements have you had on a typical day during the last 4 weeks? 
 
Two or less..................................... 1  
 
Three to four.................................... 2 (Circle one number) 
 
Five or more..................................... 3  
 
 
14. How often have you had crampy pain in your abdomen, pelvis or rectum during the last 4 
weeks? 
 
More than once a day...................... 1  
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 

29 
 
15. How big a problem, if any, has each of the following been for you? (Circle one number on 
each line) 
No 
Problem 
Very 
Small 
Problem 
Small 
Problem 
Moderate
Problem 
Big 
Problem 
a. Urgency to have a bowel movement ............
0 
1 
2 
3 
4 
b. Increased frequency of bowel movements....
0 
1 
2 
3 
4 
c. Watery bowel movements.............................
0 
1 
2 
3 
4 
d. Losing control of your stools........................
0 
1 
2 
3 
4 
e. Bloody stools ................................................
0 
1 
2 
3 
4 
f. Abdominal/ Pelvic/Rectal pain......................
0  
1 
2 
3 
4 
 
 
16. Overall, how big a problem have your bowel habits been for you during the last 4 weeks? 
 
No problem..................................... 1  
 
Very small problem......................... 2  
 
Small problem................................. 3 (Circle one number) 
 
Moderate problem........................... 4  
 
Big problem..................................... 5  
 
SEXUAL FUNCTION 
 
The next section is about your current sexual function and sexual satisfaction. Many 
of the  
 
questions are very personal, but they will help us understand the important issues that  
 
you face every day. Remember, THIS SURVEY INFORMATION IS COMPLETELY 
CONFIDENTIAL.  
Please answer honestly about THE LAST 4 WEEKS ONLY. 
 
 
17. How would you rate each of the following during the last 4 weeks? (Circle one number on 
each line) 
Very 
Poor 
to 
None 
Poor 
Fair 
Good 
Very 
Good 
a. Your level of sexual desire?............................. 1 
2 
3 
4 
5 
b. Your ability to have an erection?..................... 1 
2 
3 
4 
5 
c. Your ability to reach orgasm (climax)?........... 1 
2 
3 
4 
5 

30 
 
 
 
18. How would you describe the usual QUALITY of your erections during the last 4 weeks? 
 
None at all......................................................................... 1  
 
Not firm enough for any sexual activity............................ 2  
 
Firm enough for masturbation and foreplay only.............. 3 (Circle one number) 
 
 
Firm enough for intercourse.............................................. 4  
 
 
 
19. How would you describe the FREQUENCY of your erections during the last 4 weeks? 
 
I NEVER had an erection when I wanted one........................... 1  
 
I had an erection LESS THAN HALF the time I wanted one.…2  
 
I had an erection ABOUT HALF the time I wanted one ........... 3 (Circle one number)  
 
I had an erection MORE THAN HALF the time I wanted one....4  
 
 
I had an erection WHENEVER I wanted one............................. 5  
 
 
 
20. How often have you awakened in the morning or night with an erection during the last 4 
weeks? 
 
Never …............................................................ 1  
 
Less than once a week....................................... 2  
 
About once a week............................................ 3 (Circle one number) 
 
 
Several times a week....................…................. 4  
 
 
Daily…………………...................…............... 5  
 
 
 
21. During the last 4 weeks, how often did you have any sexual activity? 
 
Not at all............................................................. 1  
 
Less than once a week........................................ 2  
 
About once a week............................................. 3 (Circle one number) 
 
 
Several times a week.....................…................. 4  
 
 
Daily…………………..................…................. 5  
 
 
 
22. During the last 4 weeks, how often did you have sexual intercourse? 
 
Not at all............................................................ 1  
 
Less than once a week....................................... 2  

31 
 
 
About once a week........................................... 3 
(Circle one number) 
 
 
Several times a week...................…................. 4 
 
 
 
Daily…………………................…................. 5 
 
 
 
 
23. Overall, how would you rate your ability to function sexually during the last 4 weeks? 
 
Very poor............................................................ 1  
 
Poor..................................................................... 2  
 
Fair...................................................................... 3 (Circle one number) 
 
 
Good.................................................................... 4  
 
 
Very good............................................................ 5  
 
 
 
24. How big a problem during the last 4 weeks, if any, has each of the following been for you? 
(Circle one number on each line) 
No 
Problem 
Very Small 
Problem 
Small 
Problem 
Moderate 
Problem 
Big 
Problem 
a. Your level of sexual desire 
0 
1 
2 
3 
4 
b. Your ability to have an 
erection 
0 
1 
2 
3 
4 
c. Your ability to reach an 
orgasm 
0 
1 
2 
3 
4 
 
 
25. Overall, how big a problem has your sexual function or lack of sexual function been for you 
during the last 4 weeks? 
 
No problem.................................................... 1  
 
Very small problem........................................ 2  
 
Small problem................................................ 3 (Circle one number) 
 
Moderate problem.......................................... 4  
 
Big problem.................................................... 5  
 
HORMONAL FUNCTION  
 
The next section is about your hormonal function. Please consider ONLY THE LAST 
4 WEEKS. 
 
 
26. Over the last 4 weeks, how often have you experienced hot flashes? 

32 
 
 
More than once a day...................... 1  
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
27. How often have you had breast tenderness during the last 4 weeks? 
 
More than once a day...................... 1  
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
28. During the last 4 weeks, how often have you felt depressed? 
 
More than once a day...................... 1  
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
29. During the last 4 weeks, how often have you felt a lack of energy? 
 
More than once a day...................... 1  
 
About once a day............................ 2  
 
More than once a week................... 3 (Circle one number) 
 
About once a week.......................... 4  
 
Rarely or never................................ 5  
 
 
30. How much change in your weight have you experienced during the last 4 weeks, if any? 
 
Gained 10 pounds or more…..…..1 
 
 
Gained less than 10 pounds ….….2 
 
 
No change in weight..…. ….…….3 
(Circle one number) 
 
Lost less than 10 pounds ….….….4 
 
 
Lost 10 pounds or more….....……5 
 

33 
 
 
 
31. How big a problem during the last 4 weeks, if any, has each of the following been for you? 
(Circle one number on each line) 
No 
Problem 
Very Small 
Problem 
Small 
Problem 
Moderate 
Problem 
Big 
Problem 
a. Hot flashes…................... 
0 
1 
2 
3 
4 
b. Breast 
tenderness/enlargement...... 
0 
1 
2 
3 
4 
c. Loss of Body Hair........... 
0 
1 
2 
3 
4 
d. Feeling 
depressed…………............ 
0 
1 
2 
3 
4 
e. Lack of energy................ 
0 
1 
2 
3 
4 
f. Change in body 
weight…………………….. 
0 
1 
2 
3 
4 
 
 
Overall Satisfaction 
 
 
32. Overall, how satisfied are you with the treatment you received for your prostate cancer? 
 
Extremely dissatisfied............ 1 
 
 
Dissatisfied............................. 2 
 
 
Uncertain................................. 3 
(Circle one number) 
 
Satisfied................................... 4 
 
 
Extremely satisfied.................. 5 
 
 
THANK YOU!! 

34 
 
 
13.6 Appendix VI 
 
DEMOGRAPHIC FORM – Page 1 of 1 
 
 
1.  Name ____________________(last)   ____________________(first)    
 
2.  Date of Birth  ____/____/__________ 
 
3. RT Number ____________________ 
 
4.  Race: 
 Asian 
 Caucasian 
 Black 
 Other, specify________________ 
 
 
5.  Zubrod PS:  
 0 
 1 
 2 
 
6. Radiation oncologist:  __________________________________ 
 
7. Medical oncologist:  ___________________________________ 
 
8.  Surgeon:  ___________________________________________ 
 
9. Tumor category:  
 Prostate Cancer, Low Risk 
 
 
 
 Prostate Cancer, Intermediate Risk 
 
 
 Prostate Cancer, High Risk 
 
10. AJCC Staging Classification: 
 T1__ 
 T2__ 
 
 
11. Gleason Score:   
 6 or less         
 7 (3+4)        
 7 (4+3)    
 8-10 
 
12. Presenting PSA: _____ ng/ml 
Date:__________ 
 
13.  Baseline Labs (if clinically indicated): 
Total bilirubin __________ 
 
Serum albumin __________ 
 
Alkaline phosphatase __________ALT __________ AST __________ 
 
PT __________ 
PTT __________ 
 
Creatinine __________ 
 
WBC __________ Hb __________ Platelets __________ 
 
14.  Hormone Therapy: 
 No 
 
 Yes  
Start Date_________ Intended Duration_________ 
 
 
 
16.  Fiducials: 
 Date placed ____________________ 
 
 
Location 1.______________ 2._____________ 3.____________ 
 
Person completing form :  Signature _________________________ 
 
Print Name __________________________ 

35 
 
 
13.7 Appendix VII 
 
TREATMENT FORM – Page 1 of 1 
 
 
1.  Name ____________________(last)   ____________________(first)    
 
2. RT Number ____________________ 
 
3. MRI scan for planning:
 yes 
 
 
 no 
 
4. Tumor category:  
 Prostate Cancer, Low Risk 
 
 
 
 Prostate Cancer, Intermediate Risk 
 
 
 Prostate Cancer, High Risk 
 
5.  Tumor Details:  
 
 
Maximum Diameter 
(cm) 
GTV Volume 
(cc) 
PTV Margin 
(mm) 
PTV 
Volume 
(cc) 
A P 
R L 
S 
I 
 
 
 
 
 
 
 
 
 
 
6.  Treatment Portal Design: 
 
 
 Static gantry angle (coplanar), specify number of fields __________ 
 
 
 Static gantry angle (non-coplanar), specify number of fields __________ 
 
 
 Dynamic arc (coplanar), specify number of arcs __________ 
 
 
 Dynamic arc (non-coplanar), specify number of arcs __________ 
 
7.  Premedication: 
 
 
 Flomax dose________mg, start date___________ 
 
 
 Amifostine, dose 1500 mg PR 
 
 
 Bowel Prep, Stool softener, specify drug________, and Fleet enema 
 
 
 Anti-anxiety, specify drug __________, dose _____ mg,  
 
 
 Decadron, specify dose _____ mg  
 
 
 Analgesics, specify drug __________, dose _____ mg 
 
8. Dose-Fractionation Scheme: 
 
Total Dose  
(Gy) 
Dose per Fx 
 (Gy) 
# Fx Prescription  
IDL (%) 
Dmax 
(Gy) 
36.25 
7.25 
5 
 
 
 
 
 
 
 
 
 

36 
 
9. Dose to Normal Tissues: 
 
STRUCTURE 
VOLUME 
CONSTRAINT(Gy) 
DOSE (Gy) 
Spinal Cord 
Dmax 
22.5  
 
< 10 cc 
20  
 
Cauda Equina 
Dmax 
27.5  
 
< 10 cc 
25  
 
Sacral Plexus 
Dmax 
30  
 
< 10 cc 
27.5 
 
Anterior Rectal Wall 
Dmax 
38  
 
Posterior Rectal Wall 
Dmax 
20  
 
Lateral Rectal Wall 
Cumulative (L & R) 
Dmax 
36.25  
 
< 3 cc 
50  
 
Rectum superior to prostate 
Dmax 
30  
 
 
< 10 cc 
25  
 
Small Intestine 
Dmax 
30  
 
 
< 10 cc 
25  
 
Prostatic Urethra 
Dmax 
38 
 
Bladder 
Dmax 
38 
 
< 10 cc  
20 
 
Penile Bulb 
Dmax 
38 
 
< 3 cc  
30 
 
Femoral Heads 
Cumulative (L & R) 
< 10 cc 
30 
 
Skin not within fold 
Dmax 
25  
 
Skin within fold (e.g. 
gluteal fold) 
Dmax 
20 
 
 
 
 
 
 
Person completing form :  Signature _________________________  
 
Print Name __________________________ 
 
 
 

37 
 
 
13.8 Appendix VIII 
 
FOLLOW-UP VISIT FORM – Page 1 of 2 
 
1.  Name ____________________(last)   ____________________(first)    
 
2. RT Number ____________________ 
 
3. Date of Visit:  ____/____/__________ 
 
4.  Blood work:  
Lab 
Date: 
Date: 
Date: 
Total Bilirubin 
 
 
 
Albumin 
 
 
 
Alkaline 
Phosphatase 
 
 
 
ALT 
AST 
 
 
 
 
 
 
PT 
PTT 
 
 
 
 
 
 
Creatinine 
 
 
 
 
4. Radiation Therapy related adverse events 
Adverse Event 
CTC V3.0 
Grade 
Timing  
Treatment 
Comments 
ACUTE 
 
 
              
 
 Fatigue  
 
 
 
 
 Weight loss 
 
 
 
 
 Diarrhea 
 
 
 
 
 Urinary 
frequency/urgency 
 
 
 
 
 Dysuria 
 
 
 
 
 Alopecia 
 
 
 
 
 Radiation dermatitis 
 
 
 
 
 Musculoskeletal Pain 
 
 
 
 
 Neuropathy, Motor 
 
 
 
 
 Neuropathy, Sensory 
 
 
 
 
 
 
 
 
 
LATE 
 
 
 
 
 GI Bleeding 
 
 
 
 
 GI Ulceration 
 
 
 
 
 GI Perforation 
 
 
 
 
 GI Stricture 
 
 
 
 
 Fistula 
 
 
 
 
 GU Bleeding 
 
 
 
 
 GUUlceration 
 
 
 
 
 GU Perforation 
 
 
 
 

38 
 
 GU Stricture 
 
 
 
 
 Sterility 
 
 
 
 
 Impotence 
 
 
 
 
 Pelvic bone injury 
 
 
 
 
 Neuropathy, Motor 
 
 
 
 
 Neuropathy, Sensory 
 
 
 
 
 
5. Serious adverse event?  
 No   
 Yes, submit report to HIC 
 
6. Has systemic therapy been given?  
 No   
 Yes 
 
If yes, list therapy 
 
Agent(s) 
Start Date 
Stop Date 
 
__________________________ ____/____/__________ ____/____/__________ 
 
__________________________ ____/____/__________ ____/____/__________ 
 
__________________________ ____/____/__________ ____/____/__________ 
 
7. PSA since last follow-up visit  
 No   
 Yes, date ____ / ____ / __________ 
 
 
 
Current Level_________ng/ml 
 
 
 
Nadir Level__________ng/ml 
8. Radiologic Imaging since last follow-up visit  
 No   
 Yes, date ____ / ____ / __________  
 
 CT Scan      Date____/____/_________ 
 
 Bone Scan Date____/____/_________ 
 
9. Disease Status  
 
 No evidence of tumor 
 
 Biochemical recurrence 
Date____/____/_________ 
 
 Local recurrence within the treatment volume 
Date____/____/_________  
 Distant recurrence, specify site ____________________Date____/____/_________ 
 
10. Additional treatment for recurrent disease  
 
Surgery 
 Yes  
 No   Date of surgery ____/____/_________ 
 
Hormone therapy, agents _____________
 Yes  
 No   Start date ____/____/_________ 
 
Other, specify ______________________
 Yes  
 No   Start date ____/____/_________ 
  
11. Death   
  No   
 Yes, date ____/____/__________  Cause ____________________________ 
 
 
Person completing form :  Signature _________________________      
 
Print Name __________________________