CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 45 target
Drug / intervention
Stereotactic body radition (SBRT)radiation
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Histologically confirmed adenocarcinoma of the prostate without small cell features
  • ✓Clinical stage cT1c-2c, pN0 or cN0, M0 (UICC TNM 2009)
  • ✓MRI confirmation of AJCC stage T1, T2a, T2b or T2c
  • ✓Gleason score 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2)
Key exclusion· 14
  • ✕Clinical stage cT3a-3b or T4
  • ✕Evidence of T3a, T3b or T4 disease on MRI
  • ✕Positive lymph nodes or metastatic disease on imaging
  • ✕Significant tumor in transitional zone on MRI

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

Search/NCT03294889
NCT03294889Phase 2RecruitingUpdate OverdueUpdated 73mo ago · Completion was 45mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial

University Hospital, Geneva·interventional·Posted Sep 27, 2017·Updated May 14, 2020

In Brief

A Phase 2 clinical trial evaluating Stereotactic body radition (SBRT) for Prostate Cancer. Currently recruiting, targeting 45 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesSwitzerland
CollaboratorsHumanitas Hospital, Italy, University of Zurich, Kantonsspital Graubünden

Timeline

Phase 2Recruiting
20182019202020212022202320242025202620272028202920302031
First PostedSep 27, 2017
Enrollment StartSep 1, 2017
Primary CompletionOct 1, 2022
Study CompletionOct 1, 2030
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.8 years ago

Interventions

Stereotactic body radition (SBRT)radiation

Ultra-hypofractionated single-fraction SBRT with urethra-sparing with image-guidance and intra-fractional control motion with the Calypso® system. * 19 Gy in a single fraction to the whole prostate gland ± proximal seminal vesicles * 17 Gy in a single fraction to the urethra planning-risk volume (PRV)