Trial Outcomes & Findings for Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer (NCT NCT00941915)

NCT ID: NCT00941915

Last Updated: 2022-01-24

Results Overview

Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: </= 90 days post radiation treatment, a total of 90 days
• Results posted on: 2022-01-24

Participant Flow

Participant milestones

Measure	Stereotactic Radiotherapy Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

Baseline characteristics by cohort

Measure	Stereotactic Radiotherapy n=60 Participants Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: </= 90 days post radiation treatment, a total of 90 days

Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment

Outcome measures

Measure	Stereotactic Radiotherapy n=60 Participants Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Number of Participants With Genitourinary Acute Toxicity Grade 1	44 Participants
Number of Participants With Genitourinary Acute Toxicity Grade 2	15 Participants
Number of Participants With Genitourinary Acute Toxicity Grade 3	0 Participants
Number of Participants With Genitourinary Acute Toxicity Grade 4	0 Participants
Number of Participants With Genitourinary Acute Toxicity Grade 5	0 Participants

PRIMARY outcome

Timeframe: >90 days from the end of treatment, up to 3 years

Genitourinary Late Toxicity is defined as Grade 3 or higher occurring >90 days from the end of radiation treatment

Outcome measures

Measure	Stereotactic Radiotherapy n=60 Participants Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Number of Participants With Genitourinary Late Toxicity Grade 1	22 Participants
Number of Participants With Genitourinary Late Toxicity Grade 2	4 Participants
Number of Participants With Genitourinary Late Toxicity Grade 3	0 Participants
Number of Participants With Genitourinary Late Toxicity Grade 4	0 Participants
Number of Participants With Genitourinary Late Toxicity Grade 5	0 Participants

PRIMARY outcome

Timeframe: </= 90 days post radiation treatment, a total of 90 days

Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment

Outcome measures

Measure	Stereotactic Radiotherapy n=60 Participants Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Number of Participants With Gastrointestinal Acute Toxicity Grade 1	19 Participants
Number of Participants With Gastrointestinal Acute Toxicity Grade 2	3 Participants
Number of Participants With Gastrointestinal Acute Toxicity Grade 3	0 Participants
Number of Participants With Gastrointestinal Acute Toxicity Grade 4	0 Participants
Number of Participants With Gastrointestinal Acute Toxicity Grade 5	0 Participants

PRIMARY outcome

Timeframe: >90 days from the end of treatment, up to 3 years

Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring > 90 days from the end of radiation treatment

Outcome measures

Measure	Stereotactic Radiotherapy n=60 Participants Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Number of Participants With Gastrointestinal Late Toxicity Grade 1	15 Participants
Number of Participants With Gastrointestinal Late Toxicity Grade 2	5 Participants
Number of Participants With Gastrointestinal Late Toxicity Grade 3	1 Participants
Number of Participants With Gastrointestinal Late Toxicity Grade 4	0 Participants
Number of Participants With Gastrointestinal Late Toxicity Grade 5	0 Participants

SECONDARY outcome

Timeframe: 5 yrs

Population: Data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years post-treatment

Population: Only participants who provided responses for each domain were analyzed.

The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.

Outcome measures

Measure	Stereotactic Radiotherapy n=19 Participants Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form Sexual Domain	77.7 score on a scale Standard Deviation 27.6
Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form Urinary Domain	94.1 score on a scale Standard Deviation 14.7
Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form Bowel Domain	90.2 score on a scale Standard Deviation 24.0
Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form Hormonal Domain	94.4 score on a scale Standard Deviation 8.6

Adverse Events

Stereotactic Radiotherapy

Serious events: 1 serious events

Other events: 51 other events

Deaths: 4 deaths

Serious adverse events

Measure	Stereotactic Radiotherapy n=60 participants at risk Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Gastrointestinal disorders Proctitis	1.7% 1/60 • Number of events 1 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.

Other adverse events

Measure	Stereotactic Radiotherapy n=60 participants at risk Five fractions of 7.4 Gy each SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Gastrointestinal disorders Diarrhea	28.3% 17/60 • Number of events 17 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.
Gastrointestinal disorders Hemorrhoidal hemorrhage	6.7% 4/60 • Number of events 4 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.
Gastrointestinal disorders Proctitis	15.0% 9/60 • Number of events 9 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.
Gastrointestinal disorders Rectal hemorrhage	23.3% 14/60 • Number of events 14 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.
Gastrointestinal disorders Rectal pain	8.3% 5/60 • Number of events 5 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.
Renal and urinary disorders Urinary frequency	85.0% 51/60 • Number of events 51 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.
Renal and urinary disorders Urinary retention	50.0% 30/60 • Number of events 32 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.
Renal and urinary disorders Urinary tract pain	36.7% 22/60 • Number of events 22 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.
Renal and urinary disorders Urinary urgency	46.7% 28/60 • Number of events 29 • 3 years Only Genitourinary and Gastrointestinal adverse events were reported.

Additional Information

Joan Cahill, BSN RN OCN CCRP

Assistant Research Practice Manager

Phone: (919) 668-5211

Email: joan.cahill@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place