CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodesradiation
Likely dose
Hypofractionated proton beam therapy to prostate and pelvic nodes (specific dose not specified)AI-extracted
Key inclusion· 4
  • ✓Male, age ≥18 years
  • ✓Histologically confirmed prostate adenocarcinoma within 6 months of enrollment
  • ✓Clinical stage T1-2 N0 M0 with Gleason Score 7 and PSA 20-100 ng/mL, OR Any T N0 M0 with Gleason Score 8-10 and PSA ≤100 ng/mL, OR Clinical stage T3-4 N0 M0 with any Gleason Score and PSA ≤100 ng/mL, OR Clinical stage T1-2 N0 M0 with Gleason Score 4+3 and PSA 10-20 ng/mL
  • ✓Zubrod performance score ≤1
Key exclusion· 8
  • ✕Any known nodal (N1) or distant metastasis (M1)
  • ✕Previous androgen deprivation therapy lasting more than 6 months
  • ✕History of inflammatory bowel disease
  • ✕Presence of a hip prosthesis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02874014
NCT02874014Phase 2Completed
CompareCT.gov

Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

Mayo Clinic·interventional·Posted Aug 22, 2016·Updated Aug 22, 2025

In Brief

A Phase 2 clinical trial evaluating Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes for Prostate Cancer. Completed, enrolled 56 participants across 2 sites.

Detailed Summary

The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 22, 2016
Enrollment StartJul 25, 2016
Primary CompletionFeb 8, 2021
Study CompletionApr 30, 2025
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.9 years ago

Interventions

Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodesradiation