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Clinical Trials/NCT03658434
NCT03658434
Unknown
N/A

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

Zealand University Hospital2 sites in 2 countries34 target enrollmentAugust 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hormone-refractory Prostate Cancer
Sponsor
Zealand University Hospital
Enrollment
34
Locations
2
Primary Endpoint
Proportion of study participants that complete the study
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
August 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Proportion of study participants that complete the study

Time Frame: 6 months

Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose

Secondary Outcomes

  • Response in dominating symptom score (short form McGill pain Questionnaire)(Baseline, 1,3 and 6 months after radiotherapy)
  • Acute radiation toxicity score using CTCAE(Baseline, 1,3 and 6 months after radiotherapy)
  • Quality of life score using EORTC QLQ-C30(Baseline and 6 months after radiotherapy)

Study Sites (2)

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