Trial Outcomes & Findings for A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation (NCT NCT00667888)
NCT ID: NCT00667888
Last Updated: 2021-01-25
Results Overview
To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.
Recruitment status
UNKNOWN
Study phase
PHASE3
Target enrollment
225 participants
Primary outcome timeframe
8.5 years
Results posted on
2021-01-25
Participant Flow
Patients referred for radiotherapy with histologically proven adenocarcinoma of the prostate with clinical stage T1b-T3b disease and without clinical radiographic evidence of metastasis from 2001-2010.
225 patient enrolled on the trial, 222 patients met criteria and participated to be randomized on trial. 203 patients were deemed evaluable.
Participant milestones
| Measure |
Arm 1: (CIMRT) Conventional Radiotherapy
Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
|
Arm 2: (HIMRT) Hypofractionated Radiotherapy
Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
111
|
|
Overall Study
COMPLETED
|
101
|
102
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
| Measure |
Arm 1: (CIMRT) Conventional Radiotherapy
Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
|
Arm 2: (HIMRT) Hypofractionated Radiotherapy
Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Proceed with other treatment
|
3
|
3
|
|
Overall Study
Ineligible after SIM
|
0
|
2
|
Baseline Characteristics
A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation
Baseline characteristics by cohort
| Measure |
Arm 1: (CIMRT) Conventional Radiotherapy
n=111 Participants
Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
|
Arm 2: (HIMRT) Hypofractionated Radiotherapy
n=111 Participants
Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
135 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
|
111 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
111 participants
n=7 Participants
|
222 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8.5 yearsTo determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.
Outcome measures
| Measure |
Arm 1: (CIMRT) Conventional Radiotherapy
n=101 Participants
Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
|
Arm 2: (HIMRT) Hypofractionated Radiotherapy
n=102 Participants
Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
|
|---|---|---|
|
Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)
|
21 Participants
|
10 Participants
|
Adverse Events
Arm 1: (CIMRT) Conventional Radiotherapy
Serious events: 0 serious events
Other events: 56 other events
Deaths: 1 deaths
Arm 2: (HIMRT) Hypofractionated Radiotherapy
Serious events: 0 serious events
Other events: 79 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: (CIMRT) Conventional Radiotherapy
n=101 participants at risk
Patients' radiotherapy plan includes 75.6 Gy in 1.8-Gy fractions delivered over 8.4 weeks
|
Arm 2: (HIMRT) Hypofractionated Radiotherapy
n=102 participants at risk
Patients' radiotherapy plan includes 72 Gy in 2.4 Gy fractions delivered over 6 weeks
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
5.0%
5/101 • 8.5 years
|
6.9%
7/102 • 8.5 years
|
|
Renal and urinary disorders
Discomfort
|
2.0%
2/101 • 8.5 years
|
2.9%
3/102 • 8.5 years
|
|
Renal and urinary disorders
Frequency
|
16.8%
17/101 • 8.5 years
|
11.8%
12/102 • 8.5 years
|
|
Renal and urinary disorders
Incontinence
|
0.99%
1/101 • 8.5 years
|
4.9%
5/102 • 8.5 years
|
|
Renal and urinary disorders
Urgency,Retention, Hesitancy/weak stream, Strictured
|
5.0%
5/101 • 8.5 years
|
11.8%
12/102 • 8.5 years
|
|
Gastrointestinal disorders
Frequency
|
0.99%
1/101 • 8.5 years
|
2.0%
2/102 • 8.5 years
|
|
Gastrointestinal disorders
Discomfort
|
4.0%
4/101 • 8.5 years
|
2.0%
2/102 • 8.5 years
|
|
Gastrointestinal disorders
Urgency,Retention, Hesitancy/weak stream, Strictured
|
2.0%
2/101 • 8.5 years
|
2.9%
3/102 • 8.5 years
|
|
Gastrointestinal disorders
Bleeding
|
18.8%
19/101 • 8.5 years
|
31.4%
32/102 • 8.5 years
|
|
Gastrointestinal disorders
Incontinence
|
0.00%
0/101 • 8.5 years
|
0.98%
1/102 • 8.5 years
|
Additional Information
Karen Huffman, MD/ Associate Professor, Radiation Oncology Department
UT MD Anderson Cancer Center
Phone: (713) 563-2339
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place