Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer

Prostate Cancer Clinical Trial

— ultraHART  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06355050
• Other study ID #: UKJ-ultraHART
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: September 30, 2031

Study information

• Verified date: April 2024
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 with 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2031
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Quality of Life

Locations

Country	Name	City	State
Germany	Department of Radiotherapy and Radiation Oncology, Jena University Hospital	Jena

Sponsors (3)

Lead Sponsor	Collaborator
Jena University Hospital	Klinikum Stuttgart, University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Planning parameters	Dose constraints per organ, Conformity Indices, Quality of adaptive planning	for every fraction, total: 5x (1 week)
Secondary	Dose constraints	Dose constraints for organs at risk and target volumes per fraction	for every fraction, total: 5x (1 week)
Secondary	Conformity indices	Conformity indices for target volumes, per fraction (Paddick)	for every fraction, total: 5x (1 week)
Secondary	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)
Secondary	PSA-value	endpoint: Prostate-specific antigene (PSA)-recurrence free survival	longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Secondary	Overall survival		5 Years
Secondary	Recurrence free survival		5 Years