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

Primary Purpose

Hormone-refractory Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Palliative radiotherapy
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone-refractory Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. Radiation Oncology, Zealand University HospitalRecruiting
  • University Hospital Schleswig-Holstein
  • University Hospital Schleswig-Holstein

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

feasibilty

Arm Description

Palliative Radiotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response in dominating symptom score (short form McGill pain Questionnaire)
Patient score symptom/pain using the short form McGill pain Questionnaire version 2
Acute radiation toxicity score using CTCAE
Doctor score acute radiation toxicity using the CTCAE version 4
Quality of life score using EORTC QLQ-C30
Patient fill out EORTC quality of life Questionnaire form C30

Full Information

First Posted
July 30, 2018
Last Updated
September 10, 2018
Sponsor
Zealand University Hospital
Collaborators
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT03658434
Brief Title
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Acronym
PRADO
Official Title
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
University Hospital Schleswig-Holstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
Please refer to uploaded Study Protocol

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone-refractory Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
feasibilty
Arm Type
Experimental
Arm Description
Palliative Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Palliative radiotherapy
Other Intervention Name(s)
PRADO
Intervention Description
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Primary Outcome Measure Information:
Title
Proportion of study participants that complete the study
Description
Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Response in dominating symptom score (short form McGill pain Questionnaire)
Description
Patient score symptom/pain using the short form McGill pain Questionnaire version 2
Time Frame
Baseline, 1,3 and 6 months after radiotherapy
Title
Acute radiation toxicity score using CTCAE
Description
Doctor score acute radiation toxicity using the CTCAE version 4
Time Frame
Baseline, 1,3 and 6 months after radiotherapy
Title
Quality of life score using EORTC QLQ-C30
Description
Patient fill out EORTC quality of life Questionnaire form C30
Time Frame
Baseline and 6 months after radiotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Redas Trepiakas, MD
Phone
+45 56 51 3231
Email
rtr@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
K F E
Phone
+ 45 56 51 31 17
Email
laml@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper H Carl, Phd
Organizational Affiliation
Oncology, Zealand University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dep. Radiation Oncology, Zealand University Hospital
City
Næstved
State/Province
Sjaelland
ZIP/Postal Code
DK-4700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Redas Trepiakas
Phone
+4556513231
Ext
+4556513231
Email
rtr@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
K F E
Phone
+ 45 56 51 31 17
Email
laml@regionsjaelland.dk
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juergen Dunst, MD
Phone
0049 431 500-26500
Email
juergen.dunst@uksh.de
Facility Name
University Hospital Schleswig-Holstein
City
Lubeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Rades, MD
Phone
0049 451-500-45400
Email
dirk.rades@uksh.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Defined in Partner Agreement Contract
IPD Sharing Time Frame
1. august 2018
IPD Sharing Access Criteria
Innocan Partners
Citations:
PubMed Identifier
30630502
Citation
Carl J, Rades D, Doemer C, Setter C, Dunst J, Hollander NH. Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO). Radiat Oncol. 2019 Jan 10;14(1):3. doi: 10.1186/s13014-019-1209-0.
Results Reference
derived

Learn more about this trial

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

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