Trial Outcomes & Findings for MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer (NCT NCT01411319)
NCT ID: NCT01411319
Last Updated: 2021-07-13
Results Overview
Toxicity are any Grade 2 or higher treatment-related adverse events as assessed by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Up to 8.5 weeks
Results posted on
2021-07-13
Participant Flow
Participant milestones
| Measure |
LEAD Radiation Therapy
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
LEAD Radiation Therapy
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer
Baseline characteristics by cohort
| Measure |
LEAD Radiation Therapy
n=25 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8.5 weeksPopulation: All 25 participants were evaluated up to 8.5 weeks.
Toxicity are any Grade 2 or higher treatment-related adverse events as assessed by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.
Outcome measures
| Measure |
LEAD Radiation Therapy
n=25 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Number of Study Participants Experiencing Treatment-Related Toxicity
Serious Adverse Events (SAEs) with Definite Relation to Study Treatment
|
0 Participants
|
|
Number of Study Participants Experiencing Treatment-Related Toxicity
SAEs with Probable Relation to Study Treatment
|
0 Participants
|
|
Number of Study Participants Experiencing Treatment-Related Toxicity
SAEs with Possible Relation to Study Treatment
|
1 Participants
|
|
Number of Study Participants Experiencing Treatment-Related Toxicity
Adverse Events (AEs) with Definite Relation to Study Treatment
|
9 Participants
|
|
Number of Study Participants Experiencing Treatment-Related Toxicity
AEs with Probable Relation to Study Treatment
|
10 Participants
|
|
Number of Study Participants Experiencing Treatment-Related Toxicity
AEs with Possible Relation to Study Treatment
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: All 25 enrolled participants completed the duration of study treatment (8 weeks).
The percentage of enrolled patients for whom LEAD RT dose can be successfully administered following MRI-guided planning.
Outcome measures
| Measure |
LEAD Radiation Therapy
n=25 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Percentage of Enrolled Patients for Whom LEAD RT Dose Can be Successfully Administered Following MRI-guided Planning.
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2.5 YearsPopulation: Endpoint biopsy was collected only on 12 of 25 participants.
The number of participants with positive tumor cells left in the prostate after LEAD RT as evaluated by prostate biopsy.
Outcome measures
| Measure |
LEAD Radiation Therapy
n=12 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Number of Participants With Remaining Tumor Cells in the Prostate Post Treatment
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 2.5 Years Post Completion of Study Therapy (Approximately 3 years)Population: One participant was lost to follow-up at the follow-up period post-completion of treatment.
Preliminary indication of efficacy of treatment will be reported as the percentage of participants with positive prostate biopsies after completion of treatment.
Outcome measures
| Measure |
LEAD Radiation Therapy
n=24 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Percentage of Participants With Positive Prostate Biopsies After Completion of Treatment
|
4 percentage of participants
Interval 0.7 to 19.5
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: One participant was lost to follow-up at the follow-up period post-completion of treatment.
The percentage of participants achieving FFS will be reported. Failure-free is defined as no documented evidence of biochemical and/or or clinical failure or death from any cause, whichever occur first. Biochemical failure is defined is a increase of 2 or greater from nadir of Prostate Specific Antigen (PSA) levels. Clinical Failure is defined as newly identified extension outside the prostate after initial regression, or urinary obstructive symptoms with carcinoma or regional/distant failure due to radiographic evidence metastasis.
Outcome measures
| Measure |
LEAD Radiation Therapy
n=24 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Rate of Participants That Achieve Failure-Free Survival (FFS)
|
90.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Timeframe allows for study visit windows.
Overall survival is defined as the elapsed time from study enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
Outcome measures
| Measure |
LEAD Radiation Therapy
n=25 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Overall Survival (OS)
|
66 months
Interval 20.7 to 70.6
|
SECONDARY outcome
Timeframe: At Baseline (Prior to RT), at 8 weeks (Last week of RT), At 6 weeks post RT, At 3 months post RT, At 6 months post RT, At 9 months post RT, At 15 months post RT, At 27 months post RT, At 39 months post RT, At 51 months post RT, At 63 months post RTPopulation: Not all participants were able to complete the questionnaires at different timepoints in the study.
Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. The questionnaire has 5 subscales (Urinary Function, Urinary Symptoms, Bowel Habits, Sexual Function and Hormonal Function). Each subscale has a total score ranging from 0-100, with higher scores representing better HRQOL.
Outcome measures
| Measure |
LEAD Radiation Therapy
n=25 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: Prior to Radiation Therapy (RT)
|
94.5 score on a scale
Standard Deviation 10.9
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 8 Weeks (Last Week of RT)
|
92.5 score on a scale
Standard Deviation 14.4
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 6 Weeks Post-RT
|
92.8 score on a scale
Standard Deviation 20
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 3 Months Post-RT
|
93.1 score on a scale
Standard Deviation 17.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 9 Months Post-RT
|
93.5 score on a scale
Standard Deviation 16.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 15 Months Post-RT
|
93.2 score on a scale
Standard Deviation 14.5
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 27 Months Post-RT
|
93.6 score on a scale
Standard Deviation 15.5
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 39 Months Post-RT
|
95.8 score on a scale
Standard Deviation 9.2
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 51 Months Post-RT
|
92.8 score on a scale
Standard Deviation 17
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Function: 63 Months Post-RT
|
94.2 score on a scale
Standard Deviation 18.8
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: Prior to RT
|
88.5 score on a scale
Standard Deviation 13.9
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 8 Weeks (Last Week of RT)
|
79.2 score on a scale
Standard Deviation 13
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 6 Weeks Post-RT
|
85.7 score on a scale
Standard Deviation 11.9
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 3 Months Post-RT
|
87.5 score on a scale
Standard Deviation 11.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 9 Months Post-RT
|
85.1 score on a scale
Standard Deviation 17.9
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 15 Months Post-RT
|
87.2 score on a scale
Standard Deviation 13.8
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 27 Months Post-RT
|
91.4 score on a scale
Standard Deviation 7.3
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 39 Months Post-RT
|
90.8 score on a scale
Standard Deviation 7.4
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 51 Months Post-RT
|
91.2 score on a scale
Standard Deviation 13.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Urinary Symptoms: 63 Months Post-RT
|
90.8 score on a scale
Standard Deviation 8.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: Prior to RT
|
98.5 score on a scale
Standard Deviation 4.5
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 8 Weeks (Last Weeks of RT)
|
89.7 score on a scale
Standard Deviation 14.1
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 6 Weeks Post-RT
|
95.3 score on a scale
Standard Deviation 8
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 3 Months Post-RT
|
93.7 score on a scale
Standard Deviation 10
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 9 Months Post-RT
|
95.1 score on a scale
Standard Deviation 8.3
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 15 Months Post-RT
|
95.7 score on a scale
Standard Deviation 6.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 27 Months Post-RT
|
93.3 score on a scale
Standard Deviation 9.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 39 Months Post-RT
|
95.8 score on a scale
Standard Deviation 7.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 51 Months Post-RT
|
91.7 score on a scale
Standard Deviation 13.3
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Bowel Habits: 63 Months Post-RT
|
93.6 score on a scale
Standard Deviation 10.1
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: Prior to RT
|
55.2 score on a scale
Standard Deviation 23.9
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 8 Weeks (Last Week of RT)
|
39.5 score on a scale
Standard Deviation 31.6
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 6 Weeks Post-RT
|
38.2 score on a scale
Standard Deviation 34.7
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 3 Months Post-RT
|
42.7 score on a scale
Standard Deviation 37.3
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 9 Months Post-RT
|
44.6 score on a scale
Standard Deviation 33
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 15 Months Post-RT
|
49.2 score on a scale
Standard Deviation 31.4
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 27 Months Post-RT
|
44.5 score on a scale
Standard Deviation 28.8
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 39 Months Post-RT
|
41.8 score on a scale
Standard Deviation 29.2
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 51 Months Post-RT
|
47.7 score on a scale
Standard Deviation 29
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Sexual Function: 63 Months Post-RT
|
36.6 score on a scale
Standard Deviation 25.1
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: Prior to RT
|
88 score on a scale
Standard Deviation 15.1
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 8 Weeks (Last week of RT)
|
86.2 score on a scale
Standard Deviation 15.1
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 6 Weeks Post-RT
|
86.5 score on a scale
Standard Deviation 13.4
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 3 Months Post-RT
|
85.4 score on a scale
Standard Deviation 17.1
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 9 Months Post-RT
|
89.8 score on a scale
Standard Deviation 11.4
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 15 Months Post-RT
|
92.8 score on a scale
Standard Deviation 9
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 27 Months Post-RT
|
93.8 score on a scale
Standard Deviation 7.2
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 39 Months Post-RT
|
91.9 score on a scale
Standard Deviation 10.3
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 51 Months Post-RT
|
87.9 score on a scale
Standard Deviation 17.1
|
|
HrQoL as Assessed by EPIC-SF12 Questionnaire
Hormonal Function: 63 Months Post-RT
|
91.5 score on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: At Baseline (Prior to RT), at 8 weeks (Last week of RT), At 6 weeks post RT, At 3 months post RT, At 6 months post RT, At 9 months post RT, At 15 months post RT, At 27 months post RT, At 39 months post RT, At 51 months post RT, At 63 months post RTPopulation: Not all participants were able to complete the questionnaires at different timepoints in the study.
Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Outcome measures
| Measure |
LEAD Radiation Therapy
n=25 Participants
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
HrQoL as Assessed by MAX-PC Questionnaire
39 Months Post-RT
|
12.3 score on a scale
Standard Deviation 7.2
|
|
HrQoL as Assessed by MAX-PC Questionnaire
Prior to Radiation Therapy (RT)
|
13.7 score on a scale
Standard Deviation 6.3
|
|
HrQoL as Assessed by MAX-PC Questionnaire
8 Weeks (Last Week of RT)
|
15.1 score on a scale
Standard Deviation 7.2
|
|
HrQoL as Assessed by MAX-PC Questionnaire
6 Weeks Post-RT
|
13.3 score on a scale
Standard Deviation 7.5
|
|
HrQoL as Assessed by MAX-PC Questionnaire
3 Months Post-RT
|
11.7 score on a scale
Standard Deviation 7.5
|
|
HrQoL as Assessed by MAX-PC Questionnaire
9 Months Post-RT
|
12.6 score on a scale
Standard Deviation 7.5
|
|
HrQoL as Assessed by MAX-PC Questionnaire
15 Months Post-RT
|
10 score on a scale
Standard Deviation 6.9
|
|
HrQoL as Assessed by MAX-PC Questionnaire
27 Months Post-RT
|
12.2 score on a scale
Standard Deviation 6.1
|
|
HrQoL as Assessed by MAX-PC Questionnaire
51 Months Post-RT
|
11.2 score on a scale
Standard Deviation 9.1
|
|
HrQoL as Assessed by MAX-PC Questionnaire
63 Months Post-RT
|
12.9 score on a scale
Standard Deviation 6.2
|
Adverse Events
LEAD Radiation Therapy
Serious events: 1 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
LEAD Radiation Therapy
n=25 participants at risk
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
Other adverse events
| Measure |
LEAD Radiation Therapy
n=25 participants at risk
Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.
Lattice Extreme Ablative Dose Radiation Therapy: 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
Standard IMRT: 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Bloating
|
8.0%
2/25 • Number of events 2 • Up to 6 years
|
|
Blood and lymphatic system disorders
Low Testosterone
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
General disorders
Chills
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • Number of events 4 • Up to 6 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
52.0%
13/25 • Number of events 17 • Up to 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
36.0%
9/25 • Number of events 15 • Up to 6 years
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
General disorders
Edema limbs
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Endocrine disorders
Low Testosterone
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
12.0%
3/25 • Number of events 5 • Up to 6 years
|
|
General disorders
Fatigue
|
40.0%
10/25 • Number of events 11 • Up to 6 years
|
|
General disorders
Fever
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
General disorders
Increased appetite
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Hematuria
|
12.0%
3/25 • Number of events 3 • Up to 6 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Vascular disorders
Hot flashes
|
8.0%
2/25 • Number of events 2 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Investigations
Low testosterone
|
8.0%
2/25 • Number of events 2 • Up to 6 years
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
General disorders
Pain
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Penile pain
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Investigations
Platelet count decreased
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Prostatic pain
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Rectal pain
|
16.0%
4/25 • Number of events 4 • Up to 6 years
|
|
Renal and urinary disorders
Urinary obstructive symptoms, urinary hesitancy, increased frequency of bowel movement (no diarrhea)
|
28.0%
7/25 • Number of events 7 • Up to 6 years
|
|
Renal and urinary disorders
Urinary frequency
|
76.0%
19/25 • Number of events 27 • Up to 6 years
|
|
Renal and urinary disorders
Urinary incontinence
|
16.0%
4/25 • Number of events 4 • Up to 6 years
|
|
Renal and urinary disorders
Urinary retention
|
32.0%
8/25 • Number of events 9 • Up to 6 years
|
|
Renal and urinary disorders
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
16.0%
4/25 • Number of events 5 • Up to 6 years
|
|
Renal and urinary disorders
Urinary tract pain
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Urinary urgency
|
64.0%
16/25 • Number of events 25 • Up to 6 years
|
|
Investigations
Weight loss
|
4.0%
1/25 • Number of events 1 • Up to 6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place