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

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ClinicalTrials.gov Identifier: NCT03658434
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
University of Schleswig-Holstein
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hormone-refractory Prostate Cancer Radiation: Palliative radiotherapy Not Applicable

Detailed Description:
Please refer to uploaded Study Protocol

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility 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 : August 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: feasibilty
Palliative Radiotherapy
Radiation: Palliative radiotherapy
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Other Name: PRADO




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658434


Contacts
Contact: Redas Trepiakas, MD +45 56 51 3231 rtr@regionsjaelland.dk
Contact: K F E + 45 56 51 31 17 laml@regionsjaelland.dk

Locations
Denmark
Dep. Radiation Oncology, Zealand University Hospital Recruiting
Næstved, Sjaelland, Denmark, DK-4700
Contact: Redas Trepiakas    +4556513231 ext +4556513231    rtr@regionsjaelland.dk   
Contact: K F E    + 45 56 51 31 17    laml@regionsjaelland.dk   
Germany
University Hospital Schleswig-Holstein Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Juergen Dunst, MD    0049 431 500-26500    juergen.dunst@uksh.de   
University Hospital Schleswig-Holstein Not yet recruiting
Lubeck, Schleswig-Holstein, Germany, 23538
Contact: Dirk Rades, MD    0049 451-500-45400    dirk.rades@uksh.de   
Sponsors and Collaborators
Zealand University Hospital
University of Schleswig-Holstein
Investigators
Study Chair: Jesper H Carl, Phd Oncology, Zealand University Hospital
  Study Documents (Full-Text)

Documents provided by Zealand University Hospital:
Study Protocol  [PDF] February 1, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03658434     History of Changes
Other Study ID Numbers: PRADO
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Defined in Partner Agreement Contract
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 1. august 2018
Access Criteria: Innocan Partners

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs