NCT00831623

Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

Completed NA Results posted Last updated 13 March 2023

What this trial tests

NA trial testing Proton Radiation in Prostate Cancer in 167 participants. Completed in 18 July 2019.

Timeline

17 February 2009

Primary endpoint
18 July 2019

18 July 2019

Quick facts

Lead sponsor	Loma Linda University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	167
Start date	17 February 2009
Primary completion	18 July 2019
Estimated completion	18 July 2019
Sites	1 location across United States

Drugs / interventions tested

• Proton Radiation
• Proton

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Loma Linda University

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 Primary · 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.

Group	Value	95% CI
Proton Radiation Therapy	1

Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0 Secondary · 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.

Group	Value	95% CI
Proton Radiation Therapy	21

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Proton Radiation Therapy

Serious: 1/146 (1%)

Deaths: 0/146

Serious adverse events (1 terms)

Reaction	System	Proton Radiation Therapy
Hematuria	Renal and urinary disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Proton Radiation Therapy
Grade 2 Genitourinary toxicity	Renal and urinary disorders	—
Grade 2 Gastrointestinal toxicity	Gastrointestinal disorders	—

Most-reported serious reactions: Hematuria.

Data from ClinicalTrials.gov NCT00831623 adverse events section.

Sponsor's own description

The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Consensus Statement on Proton Therapy for Prostate Cancer.
   Bryant CM, Henderson RH, Nichols RC, Mendenhall WM, et al · · 2021 · cited 23× · PMID 34722807 · DOI 10.14338/ijpt-20-00031.1
2. Hypofractionated Proton Therapy in Early Prostate Cancer: Results of a Phase I/II Trial at Loma Linda University.
   Slater JM, Slater JD, Kang JI, Namihas IC, et al · · 2019 · cited 12× · PMID 31773043 · DOI 10.14338/ijpt-19-00057
3. The Role of Hypofractionation in Proton Therapy.
   Santos A, Penfold S, Gorayski P, Le H. · · 2022 · cited 11× · PMID 35565400 · DOI 10.3390/cancers14092271