At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
SBRTradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Randomized Observation Versus Stereotactic Ablative RadiatIOn for OLigometastatic Prostate CancEr (ORIOLE) Trial
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Feb 11, 2016·Updated Nov 29, 2022
In Brief
A Phase 2 clinical trial evaluating SBRT for Prostate Cancer and Oligometastases. Completed, enrolled 80 participants across 1 site.
Detailed Summary
Men with oligometastatic prostate cancer lesions will be randomized (1:2) to observation versus SBRT. The study will NOT be blinded. Within three weeks of the initial treatment planning, SBRT (1-5 fractions) will be administered.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Oligometastases
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartApr 2016
Primary CompletionAug 2018
Study CompletionOct 2022
TodayJul 2026
First PostedFeb 11, 2016
Enrollment StartApr 28, 2016
Primary CompletionAug 30, 2018
Study CompletionOct 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.4 years ago
Interventions
SBRTradiation
SBRT (1-5 fractions) will be administered.