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

Sponsor
Zealand University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03658434
Collaborator
University Hospital Schleswig-Holstein (Other)
34
Enrollment
3
Locations
1
Arm
24
Anticipated Duration (Months)
11.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Palliative radiotherapy
 N/A

Detailed Description

Please refer to uploaded Study Protocol

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Feasibility studyFeasibility study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Actual Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: feasibilty

Palliative Radiotherapy

Radiation: Palliative radiotherapy
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Other Names:
  • PRADO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    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

    3. Quality of life score using EORTC QLQ-C30 [Baseline and 6 months after radiotherapy]

      Patient fill out EORTC quality of life Questionnaire form C30

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dep. Radiation Oncology, Zealand University Hospital Næstved Sjaelland Denmark DK-4700
    2 University Hospital Schleswig-Holstein Kiel Schleswig-Holstein Germany 24105
    3 University Hospital Schleswig-Holstein Lubeck Schleswig-Holstein Germany 23538

    Sponsors and Collaborators

    • Zealand University Hospital
    • University Hospital Schleswig-Holstein

    Investigators

    • Study Chair: Jesper H Carl, Phd, Oncology, Zealand University Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Zealand University Hospital
    ClinicalTrials.gov Identifier:
    NCT03658434
    Other Study ID Numbers:
    • PRADO
    First Posted:
    Sep 5, 2018
    Last Update Posted:
    Sep 12, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Sep 12, 2018