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Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients

Study acronym: Oligo-PRESTO
StatusActive, Not Recruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 26, 2025 (before its estimated June 23, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 35 of 35 sitesv8 Show 1 more changeShow less
    • Site details revised at 35 of 35 sites
  2. Enrollment target: 350 to 550 Primary completion date: Jun 23, 2025 to Jun 23, 2026 · Completion date: Jun 23, 2028 to Feb 28, 2031 · Eligibility criteria expanded, about 20 wordsv7 Show 3 more changesShow less
    • Primary completion date: Jun 23, 2025 to Jun 23, 2026
    • Completion date: Jun 23, 2028 to Feb 28, 2031
    • Eligibility criteria expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 20, 2023 to Jun 23, 2025 Start date: Dec 10, 2019 to Jun 23, 2020 · Study sites: 21 to 35 · Completion date: Dec 20, 2027 to Jun 23, 2028 · 1 morev6 Show 4 more changesShow less
    • Start date: Dec 10, 2019 to Jun 23, 2020
    • Study sites: 21 to 35
    • Completion date: Dec 20, 2027 to Jun 23, 2028
    • Interventions: Standard of care (Drug), Stereotactic Body Radiotherapy (SBRT) (Radiation) to Standard of care (Drug), Stereotactic Body Radiotherapy (SBRT) + Standard of care (Radiation)
  4. Site details revised at 9 of 21 sitesv5
  5. Eligibility criteria expanded, about 98 wordsv4 See this version in full on ClinicalTrials.gov ↗
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Suspended to Recruiting Eligibility criteria expanded, about 6 words · Site details revised at 21 of 21 sitesv3 Show 2 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 21 of 21 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Temporary suspension since March 13 due to COVID-19 pandemic Study sites: 0 to 21 · Start date changed from estimate of Oct 20, 2019 to Dec 10, 2019 · Eligibility criteria expanded, about 1 wordv2 Show 3 more changesShow less
    • Study sites: 0 to 21
    • Start date changed from estimate of Oct 20, 2019 to Dec 10, 2019
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UNICANCER
98 trials monitored
See 7 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study. PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.
Trial Details
NCT Number NCT04115007
Lead Sponsor UNICANCER
Conditions Oligometastatic Hormone Sensitive Prostate Cancer
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov