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

NCT ID: NCT03658434

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-08-01

Brief Summary

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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

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Please refer to uploaded Study Protocol

Conditions

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Hormone-refractory Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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feasibilty

Palliative Radiotherapy

Group Type EXPERIMENTAL

Palliative radiotherapy

Intervention Type RADIATION

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

Interventions

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Palliative radiotherapy

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

Intervention Type RADIATION

Other Intervention Names

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PRADO

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesper H Carl, Phd

Role: STUDY_CHAIR

Oncology, Zealand University Hospital

Locations

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Dep. Radiation Oncology, Zealand University Hospital

Næstved, Region Sjælland, Denmark

Site Status RECRUITING

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status NOT_YET_RECRUITING

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Site Status NOT_YET_RECRUITING

Countries

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Denmark Germany

Central Contacts

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Redas Trepiakas, MD

Role: CONTACT

+45 56 51 3231

K F E

Role: CONTACT

+ 45 56 51 31 17

Facility Contacts

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Redas Trepiakas

Role: primary

+4556513231 ext. +4556513231

K F E

Role: backup

+ 45 56 51 31 17

Juergen Dunst, MD

Role: primary

0049 431 500-26500

Dirk Rades, MD

Role: primary

0049 451-500-45400

References

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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.

Reference Type DERIVED
PMID: 30630502 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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PRADO

Identifier Type: -

Identifier Source: org_study_id

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