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

Last updated: September 10, 2018
Sponsor: Zealand University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT03658434
PRADO
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 34
Study Start date:
August 01, 2018
Estimated Completion Date:
August 01, 2020

Study Description

Please refer to uploaded Study Protocol

Connect with a study center

  • Dep. Radiation Oncology, Zealand University Hospital

    Næstved, Sjaelland DK-4700
    Denmark

    Active - Recruiting

  • University Hospital Schleswig-Holstein

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • University Hospital Schleswig-Holstein

    Lubeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

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