Trial Outcomes & Findings for Proton Therapy for Low and Intermediate Risk Prostate Cancer (NCT NCT00693238)

NCT ID: NCT00693238

Last Updated: 2023-09-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 228 participants
• Primary outcome timeframe: 6 months after the end of radiation therapy
• Results posted on: 2023-09-18

Participant Flow

University of Florida Proton Therapy Institute, between 04/2008 and 04/2010

Participant milestones

Measure	Low Risk Proton Radiation 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx	Intermediate Risk Proton Radiation 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Overall Study STARTED	122	106
Overall Study COMPLETED	122	106
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Therapy for Low and Intermediate Risk Prostate Cancer

Baseline characteristics by cohort

Measure	Low Risk Proton Radiation n=122 Participants 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx	Intermediate Risk Proton Radiation n=106 Participants 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx	Total n=228 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	60 Participants n=5 Participants	44 Participants n=7 Participants	104 Participants n=5 Participants
Age, Categorical >=65 years	62 Participants n=5 Participants	62 Participants n=7 Participants	124 Participants n=5 Participants
Age, Continuous	65.3 years STANDARD_DEVIATION 7.5 • n=5 Participants	64.1 years STANDARD_DEVIATION 6.9 • n=7 Participants	64.7 years STANDARD_DEVIATION 7.2 • 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	122 Participants n=5 Participants	106 Participants n=7 Participants	228 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants	106 participants n=7 Participants	228 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after the end of radiation therapy

Outcome measures

Measure	Low Risk Proton Radiation n=122 Participants 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx	Intermediate Risk Proton Radiation n=106 Participants 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 20 years after end of radiation

Outcome measures

Outcome data not reported

Adverse Events

Low Risk Proton Radiation

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Intermediate Risk Proton Radiation

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Low Risk Proton Radiation n=122 participants at risk 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx	Intermediate Risk Proton Radiation n=106 participants at risk 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Gastrointestinal disorders Rectal hemmorhage (grade 3)	0.00% 0/122 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).	0.94% 1/106 • Number of events 1 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).
Gastrointestinal disorders Proctitis (grade 3)	0.00% 0/122 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).	0.94% 1/106 • Number of events 1 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).
Renal and urinary disorders Urinary retention (grade 3)	0.82% 1/122 • Number of events 1 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).	0.00% 0/106 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).
Renal and urinary disorders Hematuria (grade 3)	0.82% 1/122 • Number of events 1 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).	0.00% 0/106 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).

Other adverse events

Measure	Low Risk Proton Radiation n=122 participants at risk 70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx	Intermediate Risk Proton Radiation n=106 participants at risk 72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Gastrointestinal disorders Rectal hemmorhage	9.8% 12/122 • Number of events 12 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).	13.2% 14/106 • Number of events 14 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).
Renal and urinary disorders Urinary Frequency/urgency	18.0% 22/122 • Number of events 22 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).	10.4% 11/106 • Number of events 11 • These serious events cover the range from during treatment to the maximum available follow-up for any given patient (current maximum of 4.5 years).

Additional Information

Randal Henderson, MD, MBA

University of Florida

Phone: 904-588-1800

Email: rhenderson@floridaproton.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place