Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer (ultraHART)

Jena University Hospital

Status: Not yet enrolling

Conditions: Quality of Life; Adaptive Radiotherapy; Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06355050

UKJ-ultraHART

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

150 participants in 2 patient groups

Patients receiving ultrahypofractionated radiotherapy

Retrospective reference cohort

Description:

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)