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

September 10, 2018 updated by: Zealand University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Please refer to uploaded Study Protocol

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Sjaelland
      • Næstved, Sjaelland, Denmark, DK-4700
        • Recruiting
        • Dep. Radiation Oncology, Zealand University Hospital
        • Contact:
        • Contact:
  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Not yet recruiting
        • University Hospital Schleswig-Holstein
        • Contact:
      • Lubeck, Schleswig-Holstein, Germany, 23538
        • Not yet recruiting
        • University Hospital Schleswig-Holstein
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of study participants that complete the study
Time Frame: 6 months
Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

University Hospital Schleswig-Holstein

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRADO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Defined in Partner Agreement Contract

IPD Sharing Time Frame

1. august 2018

IPD Sharing Access Criteria

Innocan Partners

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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