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

Hormone-refractory Prostate Cancer Clinical Trial

— PRADO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03658434
• Other study ID #: PRADO
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: September 2018
• Source: Zealand University Hospital
• Contact: Redas Trepiakas, MD
• Phone: +45 56 51 3231
• Email: rtr[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please refer to uploaded Study Protocol

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hormone-refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Palliative radiotherapy
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer

Locations

Country	Name	City	State
Denmark	Dep. Radiation Oncology, Zealand University Hospital	Næstved	Sjaelland
Germany	University Hospital Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	University Hospital Schleswig-Holstein	Lubeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Zealand University Hospital	University of Schleswig-Holstein

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of study participants that complete the study	Proportion of study participants that complete radiotherapy with = 90% of prescribed dose	6 months
Secondary	Response in dominating symptom score (short form McGill pain Questionnaire)	Patient score symptom/pain using the short form McGill pain Questionnaire version 2	Baseline, 1,3 and 6 months after radiotherapy
Secondary	Acute radiation toxicity score using CTCAE	Doctor score acute radiation toxicity using the CTCAE version 4	Baseline, 1,3 and 6 months after radiotherapy
Secondary	Quality of life score using EORTC QLQ-C30	Patient fill out EORTC quality of life Questionnaire form C30	Baseline and 6 months after radiotherapy