Trial Outcomes & Findings for Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer (NCT NCT01040624)
NCT ID: NCT01040624
Last Updated: 2023-10-03
Results Overview
Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
6 months after the completion of radiation therapy
Results posted on
2023-10-03
Participant Flow
Participant milestones
| Measure |
HR-A
\< 15% risk of + lymph nodes (LN)
\< 15% risk of + LN: Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.
|
HR-B
\> 15% risk of + LN
\> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
19
|
|
Overall Study
COMPLETED
|
58
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
HR-A
n=58 Participants
\< 15% risk of + LN
\< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
HR-B
n=19 Participants
\> 15% risk of + LN
\> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
Total
n=77 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
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
69 years
n=7 Participants
|
68 years
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
|
58 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
19 participants
n=7 Participants
|
77 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after the completion of radiation therapyNumber of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
Outcome measures
| Measure |
HR-A
n=58 Participants
\< 15% risk of + LN
\< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
HR-B
n=19 Participants
\> 15% risk of + LN
\> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
|---|---|---|
|
Acute Grade 3 or Higher Treatment-related Toxicity Rate.
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: After radiation: every 6 months for 3 years, then annually for 20 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After radiation: every 6 months for 3 years, then annually for 20 yearsOutcome measures
Outcome data not reported
Adverse Events
HR-A
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
HR-B
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HR-A
n=58 participants at risk
\< 15% risk of + LN
\< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
HR-B
n=19 participants at risk
\> 15% risk of + LN
\> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea - acute
|
0.00%
0/58
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Constipation - acute
|
1.7%
1/58 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Abdominal cramping - acute
|
0.00%
0/58
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Pain - acute
|
0.00%
0/58
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
HR-A
n=58 participants at risk
\< 15% risk of + LN
\< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
HR-B
n=19 participants at risk
\> 15% risk of + LN
\> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
|
|---|---|---|
|
General disorders
Pain - acute
|
10.3%
6/58 • Number of events 6
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Constipation - acute
|
8.6%
5/58 • Number of events 5
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea - acute
|
6.9%
4/58 • Number of events 4
|
36.8%
7/19 • Number of events 7
|
|
Renal and urinary disorders
Dysuria - acute
|
5.2%
3/58 • Number of events 3
|
0.00%
0/19
|
|
Gastrointestinal disorders
Abdominal cramping acute
|
1.7%
1/58 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Renal and urinary disorders
Obstruction - acute
|
1.7%
1/58 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Proctitis - acute
|
1.7%
1/58 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Rectal bleeding - late
|
3.4%
2/58 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal cramping - late
|
1.7%
1/58 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Constipation - late
|
1.7%
1/58 • Number of events 1
|
0.00%
0/19
|
Additional Information
Nancy P. Mendenhall, MD
University of Florida Health Proton Therapy Institute
Phone: 904-588-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place