Trial Outcomes & Findings for Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer (NCT NCT02874014)
NCT ID: NCT02874014
Last Updated: 2025-08-22
Results Overview
Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation.
COMPLETED
PHASE2
56 participants
Between 3 months and 24 months post proton beam therapy
2025-08-22
Participant Flow
Participant milestones
| Measure |
Hypofractionation Proton Beam Therapy
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes\>\>\>
\>\>\>\>
\>\>\>
\>\>\>\> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two patients are missing scores
Baseline characteristics by cohort
| Measure |
Hypofractionation Proton Beam Therapy
n=54 Participants
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes\>\>\>\>
\>\>\>\> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
|
|---|---|
|
Age, Continuous
|
75.5 years
n=54 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=54 Participants
|
|
Performance status (ECOG)
ECOG score 0
|
47 Participants
n=54 Participants
|
|
Performance status (ECOG)
ECOG score 1
|
7 Participants
n=54 Participants
|
|
BMI
|
29.0 kg/m^2
n=54 Participants
|
|
Prostate volume (mL)
|
41.1 mL
n=54 Participants
|
|
History of prior TURP
Yes
|
5 Participants
n=54 Participants
|
|
History of prior TURP
No
|
49 Participants
n=54 Participants
|
|
Use of alpha-1 blocker
Yes
|
5 Participants
n=54 Participants
|
|
Use of alpha-1 blocker
No
|
49 Participants
n=54 Participants
|
|
Use of antiplatelet or anticoagulant medication
Yes
|
11 Participants
n=54 Participants
|
|
Use of antiplatelet or anticoagulant medication
No
|
43 Participants
n=54 Participants
|
|
Baseline IPSS score
0-7
|
28 Participants
n=52 Participants • Two patients are missing scores
|
|
Baseline IPSS score
8-19
|
22 Participants
n=52 Participants • Two patients are missing scores
|
|
Baseline IPSS score
20-35
|
2 Participants
n=52 Participants • Two patients are missing scores
|
|
Gleason score
6
|
4 Participants
n=54 Participants
|
|
Gleason score
7
|
17 Participants
n=54 Participants
|
|
Gleason score
8-10
|
33 Participants
n=54 Participants
|
|
Baseline PSA, ng/mL
|
10.7 ng/mL
n=54 Participants
|
|
T stage
T1-T2
|
23 Participants
n=54 Participants
|
|
T stage
T3a
|
21 Participants
n=54 Participants
|
|
T stage
T3b
|
10 Participants
n=54 Participants
|
|
T stage
T4
|
0 Participants
n=54 Participants
|
|
Risk
High-risk
|
52 Participants
n=54 Participants
|
|
Risk
Unfavorable intermediate risk
|
2 Participants
n=54 Participants
|
|
Duration of ADT (mo)
|
18.1 months
n=54 Participants
|
PRIMARY outcome
Timeframe: Between 3 months and 24 months post proton beam therapyToxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation.
Outcome measures
| Measure |
Hypofractionation Proton Beam Therapy
n=54 Participants
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes\>\>\>
\>\>\>\>
\>\>\>
\>\>\>\> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
|
|---|---|
|
Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0
GI grade ≥ 3
|
1 Participants
|
|
Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0
GU grade ≥ 3
|
0 Participants
|
SECONDARY outcome
Timeframe: Between 3 months and 24 months post proton beam therapyToxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation
Outcome measures
| Measure |
Hypofractionation Proton Beam Therapy
n=54 Participants
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes\>\>\>
\>\>\>\>
\>\>\>
\>\>\>\> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
|
|---|---|
|
Late Grade ≥ 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0
GI grade ≥ 2
|
6 Participants
|
|
Late Grade ≥ 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0
GU grade ≥ 2
|
19 Participants
|
SECONDARY outcome
Timeframe: Within 3 months post proton beam therapyToxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation
Outcome measures
| Measure |
Hypofractionation Proton Beam Therapy
n=55 Participants
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes\>\>\>
\>\>\>\>
\>\>\>
\>\>\>\> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
|
|---|---|
|
Acute Grade ≥ 3 GI and GU Toxicity of Interest Within 3 Months Post Proton Beam Therapy, Using the CTCAE v4.0
GI grade ≥ 3
|
0 Participants
|
|
Acute Grade ≥ 3 GI and GU Toxicity of Interest Within 3 Months Post Proton Beam Therapy, Using the CTCAE v4.0
GU grade ≥ 3
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 years post proton beam therapyDisease-free survival is defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Hypofractionation Proton Beam Therapy
n=54 Participants
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes\>\>\>
\>\>\>\>
\>\>\>
\>\>\>\> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
|
|---|---|
|
Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy
|
90 percentage of participants
Interval 81.0 to 99.0
|
SECONDARY outcome
Timeframe: 5 years post proton beam therapyDisease-free survival is defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Hypofractionation Proton Beam Therapy
n=54 Participants
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes\>\>\>
\>\>\>\>
\>\>\>
\>\>\>\> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
|
|---|---|
|
Disease-specific Survival at 5 Years Post Proton Beam Therapy
|
89 percentage of participants
Interval 80.0 to 99.0
|
Adverse Events
Hypofractionation Proton Beam Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hypofractionation Proton Beam Therapy
n=55 participants at risk
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
25/55 • Number of events 89 • 5 years post proton beam therapy
|
|
Gastrointestinal disorders
Fecal incontinence
|
12.7%
7/55 • Number of events 12 • 5 years post proton beam therapy
|
|
Gastrointestinal disorders
Proctitis
|
23.6%
13/55 • Number of events 48 • 5 years post proton beam therapy
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
40.0%
22/55 • Number of events 81 • 5 years post proton beam therapy
|
|
Gastrointestinal disorders
Rectal stenosis
|
1.8%
1/55 • Number of events 2 • 5 years post proton beam therapy
|
|
Gastrointestinal disorders
Rectal ulcer
|
1.8%
1/55 • Number of events 2 • 5 years post proton beam therapy
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.6%
2/55 • Number of events 2 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Bladder spasm
|
3.6%
2/55 • Number of events 5 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Cystitis noninfective
|
9.1%
5/55 • Number of events 13 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Hematuria
|
14.5%
8/55 • Number of events 11 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Urinary frequency
|
100.0%
55/55 • Number of events 607 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Urinary incontinence
|
23.6%
13/55 • Number of events 49 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Urinary retention
|
72.7%
40/55 • Number of events 233 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Urinary tract obstruction
|
60.0%
33/55 • Number of events 201 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Urinary tract pain
|
47.3%
26/55 • Number of events 95 • 5 years post proton beam therapy
|
|
Renal and urinary disorders
Urinary urgency
|
92.7%
51/55 • Number of events 410 • 5 years post proton beam therapy
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
98.2%
54/55 • Number of events 564 • 5 years post proton beam therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place