Trial Outcomes & Findings for Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate (NCT NCT00809991)
NCT ID: NCT00809991
Last Updated: 2026-02-18
Results Overview
Assess the number of participants of grade 2 or greater GU and GI toxicity
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2026-02-18
Participant Flow
Participant milestones
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
Overall Study
STARTED
|
91
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate
Baseline characteristics by cohort
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
n=91 Participants
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
91 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsAssess the number of participants of grade 2 or greater GU and GI toxicity
Outcome measures
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
n=91 Participants
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Erectile Dysfunction
|
9 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Cystitis
|
2 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Dysuria
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Diarrhea
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Fecal Incontinence
|
2 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Hematuria
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Hemorrhoids
|
2 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Hydronephrosis
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Proctitis
|
4 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Cystitis Noninfective
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Urinary Incontinence
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Urinary Frequency
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Urinary Urgency
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Urinary Tract Infection
|
1 Participants
|
|
Number of Participants With Grade 2 or Greater GU and GI Toxicity
Anal Hemorrhage
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 -, 24 -, and 36-month follow-upThe International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for BPH patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of LUTS and quality of life. Patients can fill out the IPSS form before examinations, but minimal interference from health care providers must be ensured. Total score range 0-35; A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
n=91 Participants
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS
Baseline
|
8.89 score on a scale
Standard Deviation 5.54
|
|
Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS
12 Month Follow-up
|
12.9 score on a scale
Standard Deviation 8.86
|
|
Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS
24 Month Follow-up
|
7.75 score on a scale
Standard Deviation 4.44
|
|
Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS
36 Month Follow-up
|
7.00 score on a scale
Standard Deviation 4.99
|
PRIMARY outcome
Timeframe: Baseline, 12 months, 24 months, and 36-month follow-upThe SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction. Total score range 5 to 25; higher scores indicate better erectile function. A total score of 21 or less indicates erectile dysfunction. 22-25: No erectile dysfunction, 17-21: Mild ED, 12-16: Mild-to-moderate ED, 8-11: Moderate ED, 5-7: Severe ED.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
n=91 Participants
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
Baseline
|
15.5 score on a scale
Standard Deviation 8.21
|
|
The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
12 Month Follow-up
|
12.9 score on a scale
Standard Deviation 8.86
|
|
The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
24 Month Follow-up
|
11.6 score on a scale
Standard Deviation 9.38
|
|
The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
36 Month follow-up
|
15.5 score on a scale
Standard Deviation 9.94
|
PRIMARY outcome
Timeframe: Baseline, 12 months, 24 months, and 36-month follow-upThe EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. Score range from 1 to 100, with higher scores better score.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
n=91 Participants
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
Baseline
|
80.1 score on a scale
Standard Deviation 27.0
|
|
EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
12 Month Follow-up
|
61.1 score on a scale
Standard Deviation 32.5
|
|
EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
24 Month Follow-up
|
60.3 score on a scale
Standard Deviation 31.5
|
|
EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)
36 Month Follow-up
|
62.1 score on a scale
Standard Deviation 34.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsBiochemical control rate (Failure Free Rate-BFFR) is defined as a binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years. Patients with biochemical failure are reported.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
n=91 Participants
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
Number of Patients With Biochemical Failure Associated With the Hypofractionated Dose Regimen
|
0 Participants
|
Adverse Events
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
Serious events: 1 serious events
Other events: 53 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
n=91 participants at risk
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
urinary tract infection
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
Other adverse events
| Measure |
Hypofractionated Radiation Therapy in Prostate Adenocarcinoma
n=91 participants at risk
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
hypofractionation: 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). T
|
|---|---|
|
Gastrointestinal disorders
Fecal Incontinence
|
2.2%
2/91 • Number of events 3 • From the time of enrollment up to 5 years
|
|
Cardiac disorders
Cardiac Arrest
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
General disorders
Chills
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Cystitis
|
2.2%
2/91 • Number of events 2 • From the time of enrollment up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
9.9%
9/91 • Number of events 9 • From the time of enrollment up to 5 years
|
|
General disorders
Fever
|
1.1%
1/91 • Number of events 2 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.2%
2/91 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Hydronephrosis
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Psychiatric disorders
insomnia
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskelatal and connective tissue disorder- other, body aches
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.1%
1/91 • Number of events 2 • From the time of enrollment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
General disorders
Pain - left flank pain
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorders - Other, degenerative changes of thoracic spine
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Psychiatric disorders
Depression
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
1.1%
1/91 • Number of events 2 • From the time of enrollment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
General disorders
Pain NCL
|
2.2%
2/91 • Number of events 2 • From the time of enrollment up to 5 years
|
|
Cardiac disorders
sinus Bradycardia
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Gastrointestinal disorders
Proctitis
|
4.4%
4/91 • Number of events 4 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Cystitis Noninfective
|
1.1%
1/91 • Number of events 1 • From the time of enrollment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
urinary frequency
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
2/91 • Number of events 2 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Flank Pain
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
Urinary tract infection
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
|
Renal and urinary disorders
urinary urgency
|
1.1%
1/91 • From the time of enrollment up to 5 years
|
Additional Information
Dr. Daniel Song
Johns Hopkins Department of Radiation Oncology
Phone: 410-502-5875
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place