NCT03658434

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

July 30, 2018

Last Update Submit

September 10, 2018

Conditions

Hormone-refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of study participants that complete the study

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

    6 months

Secondary Outcomes (3)

  • Response in dominating symptom score (short form McGill pain Questionnaire)

    Baseline, 1,3 and 6 months after radiotherapy

  • Acute radiation toxicity score using CTCAE

    Baseline, 1,3 and 6 months after radiotherapy

  • Quality of life score using EORTC QLQ-C30

    Baseline and 6 months after radiotherapy

Study Arms (1)

feasibilty

EXPERIMENTAL

Palliative Radiotherapy

Radiation: Palliative radiotherapy

Interventions

Palliative radiotherapyRADIATION

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

Also known as: PRADO
feasibilty

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dep. Radiation Oncology, Zealand University Hospital

Næstved, Region Sjælland, DK-4700, Denmark

RECRUITING

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

NOT YET RECRUITING

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 30630502DERIVED

Study Officials

  • Jesper H Carl, Phd

    Oncology, Zealand University Hospital

    STUDY CHAIR

Central Study Contacts

Redas Trepiakas, MD

CONTACT

+45 56 51 3231rtr@regionsjaelland.dk

K F E

CONTACT

+ 45 56 51 31 17laml@regionsjaelland.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

September 5, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2020

Last Updated

September 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

Defined in Partner Agreement Contract

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
1\. august 2018
Access Criteria
Innocan Partners

Locations

DK(1)DE(2)