Prostate bed irradiation with alternative radio-oncological approaches

Phase 3

Recruiting

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00015231
• Lead Sponsor: niversitätsklinikum HeidelbergAbteilung RadioOnkologie und Strahlentherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 897

Inclusion Criteria

histologically confirmed prostate cancer with classification according to the Gleason score and recent PSA-value

- Indication for the irradiation of the prostate bed (adjuvant / salvage) after prostatectomy

- Karnofsky index = 70%

- Age = 18 years

- Patient information and written consent

- Ability of the patient to consent

Exclusion Criteria

- antihormonal therapy

- lymphoid metastasis

- R2

- Stage IV (distant metastases)

- previous radiotherapy in the pelvis

- hip total endoprosthesis

- Simultaneous participation in another clinical trial that could influence the results of one of the studies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint: Hypofractionated Proton radiotherapy improves rectal quality of life (using the bowel symptom subscale of the QLQ PR 25) compared to the two photon arms. This is evaluated on the difference 12 weeks after the beginning of radiotherapy vs. baseline.

Secondary Outcome Measures

Name	Time	Method
• Non-inferiority of the hypofractionated therapy arms (arm 2 + 3) compared to the standard arm (arm 1) in terms of biochemical progression-free survival (bPFS) after 5 years. To determine the biochemical lack of recurrence, PSA determinations are carried out consecutively. Two consecutive rises above the nadir are considered recurrences.<br><br>• Overall survival (OS) after 5 years<br><br>• Quality of life according to EORTC QLQ-C30 after 2 and after 5 years<br><br>• clinical symptoms and toxicity<br>(including mortality) after NCI CTCAE version 5.0 at 2 (and after 5) years