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Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer

Study acronym: ultraHART
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 15, 2025 to Apr 1, 2026
    • Site details revised
    • Collaborators: 7 to 6
    v4
  2. Primary completion date: Sep 30, 2026 to Sep 30, 2027v3 Show 4 more changesShow less
    • Start date: Mar 30, 2025 to Sep 15, 2025
    • Study completion date: Sep 30, 2031 to Sep 30, 2032
    • Site contact updated
    • Collaborators: 3 to 7
  3. Enrollment target: 100 to 150v2 Show 5 more changesShow less
    • Start date: Jun 30, 2024 to Mar 30, 2025
    • Primary endpoints: 2 to 1
    • Secondary endpoints: 7 to 8
    • Site contact updated
    • Collaborators: 2 to 3
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.
Trial Details
NCT Number NCT06355050
Lead Sponsor Jena University Hospital
Collaborators: Klinikum Stuttgart, University Medical Center Göttingen, Kantonsspital Aarau, Hirslanden Stephanshorn, Radiologische Allianz Hamburg, University Hospital Freiburg
Conditions
(from sponsor)		 Prostate Cancer, Adaptive Radiotherapy, Quality of Life
Related terms Prostatic Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov