Hormone-refractory Prostate CancerPRADONCT03658434
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
A study testing Palliative radiotherapy in people with Hormone-refractory Prostate Cancer, run by Zealand University Hospital at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone-refractory Prostate Cancer
- What is being tested?
- Palliative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Aug 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Not yet recruiting
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
Juergen Dunst, MD, 0049 431 500-26500, juergen.dunst@uksh.de
- Not yet recruiting
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Dirk Rades, MD, 0049 451-500-45400, dirk.rades@uksh.de
Denmark1 site, 1 recruiting
- Recruiting
Dep. Radiation Oncology, Zealand University Hospital
Næstved, Region Sjælland, DK-4700
Redas Trepiakas, +4556513231 ext. +4556513231, rtr@regionsjaelland.dk
K F E, + 45 56 51 31 17, laml@regionsjaelland.dk
About this study
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.
Read the detailed description
Please refer to uploaded Study Protocol
- Conditions
- Hormone-refractory Prostate Cancer
- Being tested
- Palliative radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative radiotherapyRadiation
Also called PRADO
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
| Study group | Role | What they receive |
|---|---|---|
| feasibilty | Experimental | Palliative Radiotherapy Receives: Radiation: Palliative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study participants that complete the study
Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose
Measured: 6 months
Secondary outcomes (3)
Response in dominating symptom score (short form McGill pain Questionnaire)
Patient score symptom/pain using the short form McGill pain Questionnaire version 2
Measured: Baseline, 1,3 and 6 months after radiotherapy
Acute radiation toxicity score using CTCAE
Doctor score acute radiation toxicity using the CTCAE version 4
Measured: Baseline, 1,3 and 6 months after radiotherapy
Quality of life score using EORTC QLQ-C30
Patient fill out EORTC quality of life Questionnaire form C30
Measured: Baseline and 6 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormone-refractory Prostate CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein
- Responsible party
- Sponsor
- Investigators
- Jesper H Carl, Phd, Study chair, Oncology, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658434
- Sponsor's protocol ID
- PRADO
- Acronym
- PRADO
- Status last verified
- Sep 2018
- First submitted
- 30 Jul 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Defined in Partner Agreement Contract
Publications
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.
PubMed 30630502
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT03658434
- Acronym / sponsor ID
- PRADO / PRADO
- Conditions
- Hormone-refractory Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| feasibilty | Experimental | Radiation: Palliative radiotherapyPalliative Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative radiotherapyAlso: PRADOPalliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer | Radiation | feasibilty |
Primary outcome
Proportion of study participants that complete the study
Time frame: 6 months
Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose
3 secondary outcomes
Response in dominating symptom score (short form McGill pain Questionnaire)
Time frame: Baseline, 1,3 and 6 months after radiotherapy
Acute radiation toxicity score using CTCAE
Time frame: Baseline, 1,3 and 6 months after radiotherapy
Quality of life score using EORTC QLQ-C30
Time frame: Baseline and 6 months after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Derived from this study: PubMed 30630502Carl 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.
- Individual participant dataSharing planned: Yes. Defined in Partner Agreement Contract
Related trials for Hormone-refractory Prostate Cancer
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NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper H Carl, Phd study chair
Oncology, Zealand University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative radiotherapy in people with Hormone-refractory Prostate Cancer, run by Zealand University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Redas Trepiakas, MD (+45 56 51 3231, rtr@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of study participants that complete the study (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03658434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.