Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer (ultraHART)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Prostate Cancer; Adaptive Radiotherapy

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Klaus Pietschmann, MD. MBa. LLM.; Phone Number: 00 - 49 03641 - 9-328401; Email: strahlentherapie@med.uni-jena.de

Study Locations

• Germany
  • Jena, Germany
    • Department of Radiotherapy and Radiation Oncology, Jena University Hospital
    • Contact: Klaus Pietschmann, MD; Email: klaus.pietschmann@med.uni-jena.de
    • Principal Investigator: Georg Wurschi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• low / intermediate risk prostate cancer
• prostate volume < 100 ccm

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients receiving ultrahypofractionated radiotherapy
Retrospective reference cohort; reference cohort of patients who underwent normofractionated radiotherapy or moderately hypofractionated radiotherapy earlier. matching 1:1:1 by tumor stage and risk profile (d'Amico)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (EPIC 26)	Expanded Prostate Cancer Index Composite 26 (questionnaire)	longitudinally: before + during RT and during follow up (5 years, at least bi-annually)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		5 Years
Toxicity (CTCAE v5.0)	Common Terminology Criteria for Adverse Events v5.0	longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Planning parameters	Dose constraints per organ, Conformity Indices, Quality of adaptive planning	for every fraction, total: 5x (1 week)
Dose constraints	Dose constraints for organs at risk and target volumes per fraction	for every fraction, total: 5x (1 week)
Quality of adaptive planning	Semi-quantitative score to evaluate the quality of the adaptive plan and if revisions would be required	for every fraction, total: 5x (1 week)
PSA-value	endpoint: Prostate-specific antigene (PSA)-recurrence free survival	longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Recurrence free survival		5 Years
Conformity indices	Conformity indices for target volumes, per fraction	for every fraction, total: 5x (1 week)

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: Kantonsspital Aarau; University Hospital Schleswig-Holstein; Klinikum Stuttgart; University Medical Center Göttingen; Hirslanden Stephanshorn; Universitätsklinik Würzburg; Radiologische Allianz Hamburg

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2032

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 6, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 31, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Adaptive Radiotherapy; Ultra-hypofractionation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UKJ-ultraHART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No