Clinical trial NCT03658434: Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Official title: Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hormone-refractory Prostate Cancer
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
First posted: 2018-09-05
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Proportion of study participants that complete the study
timeFrame: 6 months
Secondary outcomes:
measure: Response in dominating symptom score (short form McGill pain Questionnaire)
timeFrame: Baseline, 1,3 and 6 months after radiotherapy
measure: Acute radiation toxicity score using CTCAE
timeFrame: Baseline, 1,3 and 6 months after radiotherapy
measure: Quality of life score using EORTC QLQ-C30
timeFrame: Baseline and 6 months after radiotherapy
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Dep. Radiation Oncology, Zealand University Hospital
state: Sjaelland
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Lubeck
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: Oncology, Zealand University Hospital
name: Jesper H Carl, Phd
role: STUDY_CHAIR
References:
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.