CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 140 target
Drug / intervention
carbon ion irradation +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 11
  • ✓Pathologically confirmed adenocarcinoma of prostate
  • ✓Stage cT1-3N0M0 localized prostate cancer
  • ✓Prior PSMA PET/CT and mpMRI imaging completed before treatment
  • ✓No lymph node or distant metastasis involvement
Key exclusion· 5
  • ✕No pathologically confirmed adenocarcinoma
  • ✕Pelvic lymph node metastasis (N1)
  • ✕Distant metastasis (M1)
  • ✕Prior pelvic radiotherapy

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

Search/NCT05010343
NCT05010343Phase 2RecruitingUpdate OverdueUpdated 55mo ago · Completion was 12mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
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Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial

Shanghai Proton and Heavy Ion Center·interventional·Posted Aug 18, 2021·Updated Nov 15, 2021

In Brief

A Phase 2 clinical trial evaluating carbon ion irradation and Carbon Ion Irradiation With SIB for Localized Prostate Cancer. Currently recruiting, targeting 140 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography / computed tomography (PET/CT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocalized Prostate Cancer
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
20212022202320242025202620272028
First PostedAug 18, 2021
Enrollment StartOct 15, 2020
Primary CompletionJul 1, 2025
Study CompletionJul 1, 2028
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 4.9 years ago

Interventions

carbon ion irradationradiation

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle

Carbon Ion Irradiation With SIBradiation

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET/CT and mpMRI