CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 1,128 target
Drug / intervention
SBRTradiation
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Age ≥18 years at randomisation
  • ✓Histopathological confirmation of prostate adenocarcinoma with Gleason/ISUP grade group scoring within 12 months
  • ✓Planned for 12-36 months androgen deprivation therapy
  • ✓High-risk localized prostate cancer: Gleason 8-10 (grade groups 4-5) and/or Stage T3a/b or T4 and/or PSA >20 ng/ml (or >10 ng/ml on 5-alpha reductase inhibitors)
Key exclusion· 8
  • ✕N1 or M1 disease
  • ✕PSA >50 ng/ml (or >25 ng/ml on 5-alpha reductase inhibitors) unless PET-CT confirms N0M0
  • ✕Previous active treatment for prostate cancer
  • ✕SBRT contraindicated: prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms, or bowel in close apposition to target volumes

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

Search/NCT05613023
NCT05613023Phase 3RecruitingHigh MomentumUpdated 21mo ago
Long Recruiting
CompareCT.gov

PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT

Institute of Cancer Research, United Kingdom·interventional·Posted Nov 14, 2022·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating SBRT for Prostate Cancer. Currently recruiting, targeting 1,128 participants across 42 sites in 3 countries.

Signals

Enrolling ahead of pace

Detailed Summary

This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesIreland, New Zealand, United Kingdom
CollaboratorsProstate Cancer UK

Timeline

Phase 3Recruiting
20232024202520262027202820292030
First PostedNov 14, 2022
Enrollment StartSep 9, 2022
Primary CompletionJun 1, 2028
Study CompletionJun 1, 2030
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 3.6 years agoPrimary completion in 1.9 years

Interventions

SBRTradiation

Stereotactic Body Radiotherapy