Trial Outcomes & Findings for Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer (NCT NCT01982786)
NCT ID: NCT01982786
Last Updated: 2023-08-21
Results Overview
The ability to accrue 60 patients over an 18 month period to a study that randomizes men with intermediate-risk prostate cancer to curative intent treatment with image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost within a Canadian multicentre setting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
21 months
Results posted on
2023-08-21
Participant Flow
Participant milestones
| Measure |
Arm 1
IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
|
Arm 2
IGRT 37.5 Gy in 15 fractions
\+ HDR brachytherapy boost 15 Gy
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Brachytherapy: Brachytherapy boost
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=29 Participants
IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
|
Arm 2
n=28 Participants
IGRT 37.5 Gy in 15 fractions
\+ HDR brachytherapy boost 15 Gy
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Brachytherapy: Brachytherapy boost
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<= 65 years
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Customized
> 65 years
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Prostate Carcinoma Disease clinical T Stage
T1c
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Prostate Carcinoma Disease clinical T Stage
T2a
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Prostate Carcinoma Disease clinical T Stage
T2b
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Prostate Carcinoma Disease clinical T Stage
T2c
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
PSA
< 10
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
PSA
10-20
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
The AUA Symptom Index Score
AUA score from 0 to 9
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
The AUA Symptom Index Score
AUA score from 10 to 19
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
combined Gleason Score
Gleason Score of 7
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
combined Gleason Score
Others
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
The ECOG Scale of Performance Status
0
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
The ECOG Scale of Performance Status
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 monthsThe ability to accrue 60 patients over an 18 month period to a study that randomizes men with intermediate-risk prostate cancer to curative intent treatment with image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost within a Canadian multicentre setting.
Outcome measures
| Measure |
Arm 1
n=29 Participants
IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
|
Arm 2
n=28 Participants
IGRT 37.5 Gy in 15 fractions
\+ HDR brachytherapy boost 15 Gy
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Brachytherapy: Brachytherapy boost
|
|---|---|---|
|
Feasibility of Ability to Accrue Patients
|
29 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 21 monthsPopulation: As treated population
Acute genitourinary (GU) and gastrointestinal (GI) adverse events.
Outcome measures
| Measure |
Arm 1
n=29 Participants
IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
|
Arm 2
n=26 Participants
IGRT 37.5 Gy in 15 fractions
\+ HDR brachytherapy boost 15 Gy
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Brachytherapy: Brachytherapy boost
|
|---|---|---|
|
Number of Participants Reported Adverse Events
GASTROINTESTINAL DISORDERS
|
1 Participants
|
0 Participants
|
|
Number of Participants Reported Adverse Events
RENAL AND URINARY DISORDERS
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 21 monthsTreatment compliance will be monitored on an ongoing basis by Central Office and the designated radiotherapy quality assurance reviewer and will be described for both arms.
Outcome measures
| Measure |
Arm 1
n=29 Participants
IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
|
Arm 2
n=26 Participants
IGRT 37.5 Gy in 15 fractions
\+ HDR brachytherapy boost 15 Gy
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Brachytherapy: Brachytherapy boost
|
|---|---|---|
|
Treatment Compliance
Minor Deviation
|
14 Participants
|
18 Participants
|
|
Treatment Compliance
Major Deviation
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: As treated population.
The time from the the time from IGRT Real Time Review Signed to IGRT Real Time Review Uploaded.
Outcome measures
| Measure |
Arm 1
n=29 Participants
IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
|
Arm 2
n=26 Participants
IGRT 37.5 Gy in 15 fractions
\+ HDR brachytherapy boost 15 Gy
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Brachytherapy: Brachytherapy boost
|
|---|---|---|
|
Radiotherapy Quality Assurance -Timing
|
4 Day
Interval 0.0 to 12.0
|
3 Day
Interval 0.0 to 21.0
|
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm 2
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm 1
n=29 participants at risk
IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
|
Arm 2
n=26 participants at risk
IGRT 37.5 Gy in 15 fractions
\+ HDR brachytherapy boost 15 Gy
Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Brachytherapy: Brachytherapy boost
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29
|
0.00%
0/26
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/29
|
7.7%
2/26
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place