Trial Outcomes & Findings for Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer (NCT NCT00831623)

NCT ID: NCT00831623

Last Updated: 2023-03-13

Results Overview

To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 167 participants
• Primary outcome timeframe: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years
• Results posted on: 2023-03-13

Participant Flow

Participant milestones

Measure	Proton Radiation Therapy Single arm Proton Radiation: 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) Proton: As above
Overall Study STARTED	167
Overall Study Treated Per Protocol	158
Overall Study At Least 2 Years Since Completing Treatment	146
Overall Study COMPLETED	145
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	Proton Radiation Therapy Single arm Proton Radiation: 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) Proton: As above
Overall Study Withdrawal by Subject	9
Overall Study Lost to Follow-up	1
Overall Study Not 2 years post-treatment	12

Baseline Characteristics

8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data

Baseline characteristics by cohort

Measure	Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer n=146 Participants Patients with localized prostate cancer with the following characteristics: * Histologically confirmed adenocarcinoma within 180 days of registration * History \& Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration * Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment * Clinical stage, Tumor Stage (T1-T2C) * Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration
Age, Categorical <=18 years	0 Participants n=146 Participants • 8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data
Age, Categorical Between 18 and 65 years	70 Participants n=146 Participants • 8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data
Age, Categorical >=65 years	76 Participants n=146 Participants • 8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data
Age, Continuous	65 Years n=146 Participants • 8 refused treatment, 158 treated per protocol, 146 at least 2 years since completing treatment, 1 with no follow up data
Sex/Gender, Customized Male	146 Participants n=146 Participants
Region of Enrollment United States	146 Participants n=146 Participants
PSA	4.98 ng/mL n=146 Participants

PRIMARY outcome

Timeframe: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years

To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.

Outcome measures

Measure	Proton Radiation Therapy n=146 Participants Single arm Proton Radiation: 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) Proton: As above
Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0	1 Participants

SECONDARY outcome

Timeframe: Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years

To determine if late CTCAE version 4.0 Grade 2 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.

Outcome measures

Measure	Proton Radiation Therapy n=146 Participants Single arm Proton Radiation: 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) Proton: As above
Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0	21 Participants

Adverse Events

Proton Radiation Therapy

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure

Proton Radiation Therapy n=146 participants at risk Single arm Proton Radiation: 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) Proton: As above

Renal and urinary disorders Hematuria

0.68% 1/146 • Number of events 1 • Patients toxicity was assessed at 6 month intervals following completion of treatment through the duration of the trial for a minimum of 2 years, with an average of 5 years. Acute toxicity was defined as toxicity during treatment and within the three-month post-treatment time point. Late toxicity was defined as toxicity occurring greater than three months post-treatment. Follow-up visits were conducted every three months for the first two years after treatment, every six months for the next three years, and annually thereafter. During follow-up visits history and physical exam were performed, PSA was measured, and toxicity was evaluated.

Other adverse events

Measure	Proton Radiation Therapy n=146 participants at risk Single arm Proton Radiation: 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions) Proton: As above
Gastrointestinal disorders Grade 2 Gastrointestinal toxicity	4.8% 7/146 • Number of events 7 • Patients toxicity was assessed at 6 month intervals following completion of treatment through the duration of the trial for a minimum of 2 years, with an average of 5 years. Acute toxicity was defined as toxicity during treatment and within the three-month post-treatment time point. Late toxicity was defined as toxicity occurring greater than three months post-treatment. Follow-up visits were conducted every three months for the first two years after treatment, every six months for the next three years, and annually thereafter. During follow-up visits history and physical exam were performed, PSA was measured, and toxicity was evaluated.
Renal and urinary disorders Grade 2 Genitourinary toxicity	8.9% 13/146 • Number of events 13 • Patients toxicity was assessed at 6 month intervals following completion of treatment through the duration of the trial for a minimum of 2 years, with an average of 5 years. Acute toxicity was defined as toxicity during treatment and within the three-month post-treatment time point. Late toxicity was defined as toxicity occurring greater than three months post-treatment. Follow-up visits were conducted every three months for the first two years after treatment, every six months for the next three years, and annually thereafter. During follow-up visits history and physical exam were performed, PSA was measured, and toxicity was evaluated.

Additional Information

Dr. Jason Slater

LomaLindaU

Phone: 909-558-4243

Email: jaslater@llu.edu

Results disclosure agreements

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