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NCT Number: NCT06355050

Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Adaptive Radiotherapy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Quality of Life Urogenital Diseases Urogenital Neoplasms

Age range

18 year–120 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Radiotherapy and Radiation Oncology, Jena University Hospital

Jena, Germany

Location status: Recruiting

Location contact

Georg Wurschi, MD

PRINCIPAL_INVESTIGATOR

Klaus Pietschmann, MD

CONTACT

[email protected]

+4936419328401

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no androgen deprivation therapy within the last 2 months prior to RT
  • good performance status (Eastern Cooperative Oncology Group, ECOG, 0/1)
  • no secondary malignancy

Treatment and study plan

Primary outcomes

  1. Quality of Life (EPIC 26)

    Time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)

    Expanded Prostate Cancer Index Composite 26 (questionnaire)

Secondary outcomes

  1. Toxicity (CTCAE v5.0)

    Time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)

    Common Terminology Criteria for Adverse Events v5.0

  2. Planning parameters

    Time frame: for every fraction, total: 5x (1 week)

    Dose constraints per organ, Conformity Indices, Quality of adaptive planning

  3. Dose constraints

    Time frame: for every fraction, total: 5x (1 week)

    Dose constraints for organs at risk and target volumes per fraction

  4. Conformity indices

    Time frame: for every fraction, total: 5x (1 week)

    Conformity indices for target volumes, per fraction

  5. Quality of adaptive planning

    Time frame: for every fraction, total: 5x (1 week)

    Semi-quantitative score to evaluate the quality of the adaptive plan and if revisions would be required

  6. PSA-value

    Time frame: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)

    endpoint: Prostate-specific antigene (PSA)-recurrence free survival

  7. Overall survival

    Time frame: 5 Years

  8. Recurrence free survival

    Time frame: 5 Years

Study contacts

Contact information is provided by the study sponsor or research team.

Klaus Pietschmann, MD. MBa. LLM.

CONTACT

[email protected]

00 - 49 03641 - 9-328401

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

  • Hirslanden Stephanshorn
  • Kantonsspital Aarau
  • Klinikum Stuttgart
  • Radiologische Allianz Hamburg
  • University Hospital Freiburg
  • University Medical Center Göttingen

Registry information

Official study title

Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART

Acronym: ultraHART

Important dates

Study start
2026
Primary completion
2027
Study completion
2032
First posted
Apr 9, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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