# ORIOLE

Source: https://onco.cc/trials/oriole/  
OnCo record `oriole` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Treating one to three secondary tumours with precise radiotherapy cut the chance of the cancer progressing within six months from three in five to one in five, and worked best when a PSMA scan showed nothing had been missed.

## Summary

ORIOLE randomised 54 men with recurrent hormone-sensitive prostate cancer and one to three metastases on conventional imaging, 36 to stereotactic ablative radiotherapy and 18 to observation. Progression was defined by PSA rise, progression on conventional imaging, symptomatic progression, start of androgen deprivation for any reason, or death.

Progression at 6 months occurred in 7 of 36 men (19 percent) after radiotherapy and 11 of 18 (61 percent) under observation (p=0.005). Median progression-free survival was not reached with radiotherapy against 5.8 months with observation, hazard ratio 0.30 (95 percent confidence interval 0.11 to 0.81, p=0.002). No toxic effects of grade 3 or greater were observed.

The finding that made ORIOLE more than a small positive trial is the imaging one. Men had PSMA PET that was not used for treatment planning, and total consolidation of all PSMA-avid disease reduced the risk of new lesions at 6 months from 63 to 16 percent (p=0.006). Treating what conventional imaging can see, while leaving what it cannot, is much less effective than treating everything.

T-cell receptor sequencing showed significant clonotypic expansion after radiotherapy, and baseline clonality correlated with progression in the radiotherapy arm only, evidence that the effect is partly immunological. These are exploratory findings in 54 men and should be read as hypotheses.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: ORIOLE; Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer
- Registry id: NCT02680587
- Phase: 2
- Setting: Recurrent hormone-sensitive prostate cancer with one to three metastases on conventional imaging, no androgen deprivation within 6 months of enrolment or 3 or more years in total: stereotactic ablative radiotherapy against observation, randomised 2:1, with progression at 6 months as the primary outcome
- Sponsor: Johns Hopkins University
- Enrolled: 54
- Result: Progression at 6 months 19 percent after stereotactic ablative radiotherapy against 61 percent under observation (p=0.005); total consolidation of PSMA-avid disease reduced new lesions at 6 months from 63 to 16 percent.
- Outcomes: Progression at 6 months: Stereotactic ablative radiotherapy 19% vs Observation 61%; Progression-free survival (median): Stereotactic ablative radiotherapy vs Observation 5.8 months, HR 0.3; New lesions at 6 months by total PSMA consolidation: All PSMA-avid disease treated 16% vs PSMA-avid disease left untreated 63%
- Replication: STOMP found the same direction in 62 men with an androgen deprivation-free survival endpoint; neither trial was powered for survival and the phase 3 trials are still running.

## Sources

- ClinicalTrials.gov NCT02680587: https://clinicaltrials.gov/study/NCT02680587
- ORIOLE (JAMA Oncology 2020): https://doi.org/10.1001/jamaoncol.2020.0147

## Connected records

- cancers: [Biochemical recurrence of prostate cancer](https://onco.cc/cancers/prostate-bcr/), [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [PSMA PET](https://onco.cc/technologies/psma-pet/), [SBRT / SABR (stereotactic radiotherapy)](https://onco.cc/technologies/sbrt/), [Stereotactic ablative radiotherapy for oligometastatic disease](https://onco.cc/technologies/sabr-oligometastases/)
- terms: [Biochemical recurrence (BCR)](https://onco.cc/terms/biochemical-recurrence/), [Oligometastatic disease](https://onco.cc/terms/oligometastatic/), [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/)
- trials: [proPSMA](https://onco.cc/trials/propsma/), [SABR-COMET: stereotactic ablative radiotherapy for oligometastatic cancer](https://onco.cc/trials/sabr-comet/), [STOMP](https://onco.cc/trials/stomp-oligorecurrence/)

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