Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer

Not Applicable

• Conditions: Hormone-refractory Prostate Cancer
• Interventions: Radiation: Palliative radiotherapy

• Registration Number: NCT03658434
• Lead Sponsor: Zealand University Hospital

Brief Summary

The aim of the present feasibility study of a new short palliative radiotherapy regime that apply to patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominating debilitating symptom. Diffusion weighted magnetic resonance imaging (DWI) will apply to identify both the lesion and the most aggressive part of the lesion. The symptomatic lesions will be treated with a dose of 4 x 5 Gy, while for the most aggressive part of the lesion the dose will be escalated to 4 x 7 Gy using a simultaneous integrated boost (SIB) technique.

Detailed Description

Please refer to uploaded Study Protocol

Study Timeline

• Study First Submitted: 2018-07-30
• Study Start: 2018-08-01
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-05
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-12
• Primary Completion: 2019-08-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

1. Patients with hormone refractory biopsy proven prostate cancer
2. Presenting with a dominating debilitating symptom
3. Expected median survival of 12 months
4. Focal irradiation of lesion is feasible
5. Systemic therapy according to guidelines
6. age ≥18 years
7. Legal capacity, able to understand consequences of the trial
8. Written informed consent

Exclusion Criteria

1. Relevant comorbidity (limiting radiotherapy according to protocol)
2. Prior radiotherapy limitations to administer radiotherapy according to protocol
3. No large metal implants in vicinity of lesion
4. Department dose constraints for normal tissue can't be met
5. Large bony lesions with extensive osseous destruction
6. Patients symptoms do not correlate with MR findings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
feasibilty	Palliative radiotherapy	Palliative Radiotherapy

Primary Outcome Measures

Name	Time	Method
Proportion of study participants that complete the study	6 months	Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose

Secondary Outcome Measures

Name	Time	Method
Response in dominating symptom score (short form McGill pain Questionnaire)	Baseline, 1,3 and 6 months after radiotherapy	Patient score symptom/pain using the short form McGill pain Questionnaire version 2
Acute radiation toxicity score using CTCAE	Baseline, 1,3 and 6 months after radiotherapy	Doctor score acute radiation toxicity using the CTCAE version 4
Quality of life score using EORTC QLQ-C30	Baseline and 6 months after radiotherapy	Patient fill out EORTC quality of life Questionnaire form C30

Trial Locations

Locations (2)

University Hospital Schleswig-Holstein; 🇩🇪 Lubeck, Schleswig-Holstein, Germany

Dep. Radiation Oncology, Zealand University Hospital; 🇩🇰 Næstved, Sjaelland, Denmark