Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer

Not yet recruiting

• Conditions: Quality of Life; Adaptive Radiotherapy; Prostate Cancer

• Registration Number: NCT06355050
• Lead Sponsor: Jena University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-04-06
• Study First Posted: 2024-04-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16
• Study Start: 2025-03-30
• Primary Completion: 2026-09-30
• Study Completion: 2031-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 150

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Radiotherapy and Radiation Oncology, Jena University Hospital; 🇩🇪 Jena, Germany