Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer

NCT06355050 | Not Yet Recruiting

• 1 other identifier: UKJ-ultraHART
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Adaptive Radiotherapy; Quality of Life

Keywords

Adaptive Radiotherapy; Quality of Life; Ultra-hypofractionation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Toxicity (CTCAE v5.0)

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

• Planning parameters

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

• Dose constraints

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

• Conformity indices

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

• Quality of adaptive planning

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

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* low / intermediate risk prostate cancer * prostate volume \< 100 ccm

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Radiotherapy and Radiation Oncology, Jena University Hospital

Jena, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Klaus Pietschmann, MD. MBa. LLM.

CONTACT

00 - 49 03641 - 9-328401; strahlentherapie@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 9, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2032
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)