Prostate CancerNCT04535908
Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
A study testing Hypofractionated radiotherapy in people with Prostate Cancer and Radiotherapy Side Effect, run by Medical University of Graz at 1 site in Austria.
Trial summary
The majority of all new prostate cancer cases are diagnosed in men aged > 70 years, with the highest incidence in men aged > 90 years. Management options for localized prostate cancer include active surveillance in patients with low-risk disease, radical prostatectomy or external beam radiation therapy. Read more about this study
- Who is it for?
- Ages 75 years and older, men only
- Conditions the study is for
- Prostate Cancer, Radiotherapy Side Effect
- What is being tested?
- Hypofractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- 16 Sep 2020to 25 May 2022
- 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 75 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- histologically confirmed prostate cancer adenocarcinoma
- definitive radiotherapy for curative intent
- low or intermediate risk prostate cancer
- patient age ≥ 75 years
- given informed consent
Who cannot join
- chronic inflammatory bowel disease
- high risk prostate cancer
- lymph node or distant metastases
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
The majority of all new prostate cancer cases are diagnosed in men aged > 70 years, with the highest incidence in men aged > 90 years. Management options for localized prostate cancer include active surveillance in patients with low-risk disease, radical prostatectomy or external beam radiation therapy.
In previous studies, hypofractionated prostate cancer irradiation regimens have been shown to represent a highly effective treatment option for prostate cancer. However, patients aged 75 years or older were underrepresented in most trials resulting in the lack of a robust evidence base.
The proposed study will evaluate radiation-induced toxicity as well as outcome after hypofractionated external beam radiotherapy in prostate cancer patients aged 75 years or older.
- Conditions
- Prostate Cancer, Radiotherapy Side Effect
- Being tested
- Hypofractionated radiotherapy
- Keywords
- Hypofractionated radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
Hypofractionated radiotherapy in prostate cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiotherapy | Experimental | Not described Receives: Radiation: Hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute radiation - induced toxicity
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: Measurement at the last 1 day of radiotherapy
Acute radiation - induced toxicity
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measured: Measurement 3 months after completion of radiotherapy
Secondary outcomes (3)
Overall survival
Analysis of survival
Measured: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Recurrence (biochemical)
Assessed by measurement of prostate specific antigen (PSA)
Measured: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Recurrence (local)
Assessed by magnetic resonance imaging (MRI), positron emission tomography (optional)
Measured: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start16 Sep 2020
- Primary completion25 May 2022
- Study completion25 May 2022
Why it stopped: Treatment standard has changed.
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Langsenlehner, MD, Principal investigator, Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535908
- Sponsor's protocol ID
- 1091/2020
- Status last verified
- Sep 2022
- First submitted
- 25 Aug 2020
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
PubMed 27339115
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
- ClinicalTrials.gov ID
- NCT04535908
- Acronym / sponsor ID
- 1091/2020
- Conditions
- Prostate Cancer, Radiotherapy Side Effect
- Keywords
- Hypofractionated radiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment standard has changed.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 2 Sep 2020 (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 majority of all new prostate cancer cases are diagnosed in men aged > 70 years, with the highest incidence in men aged > 90 years. Management options for localized prostate cancer include active surveillance in patients with low-risk disease, radical prostatectomy or external beam radiation therapy.
In previous studies, hypofractionated prostate cancer irradiation regimens have been shown to represent a highly effective treatment option for prostate cancer. However, patients aged 75 years or older were underrepresented in most trials resulting in the lack of a robust evidence base.
The proposed study will evaluate radiation-induced toxicity as well as outcome after hypofractionated external beam radiotherapy in prostate cancer patients aged 75 years or older.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiotherapy | Experimental | Radiation: Hypofractionated radiotherapy |
Who may qualify
- Ages
- 75 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- histologically confirmed prostate cancer adenocarcinoma
- definitive radiotherapy for curative intent
- low or intermediate risk prostate cancer
- patient age ≥ 75 years
- given informed consent
Key exclusion criteria (4 listed)
- chronic inflammatory bowel disease
- high risk prostate cancer
- lymph node or distant metastases
- unable to give informed consent
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 |
|---|---|---|
| Hypofractionated radiotherapyHypofractionated radiotherapy in prostate cancer patients | Radiation | Hypofractionated radiotherapy |
Primary outcome
Acute radiation - induced toxicity
Time frame: Measurement at the last 1 day of radiotherapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Acute radiation - induced toxicity
Time frame: Measurement 3 months after completion of radiotherapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
3 secondary outcomes
Overall survival
Time frame: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Recurrence (biochemical)
Time frame: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Recurrence (local)
Time frame: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Results and safety
The study was stopped early (reason given: Treatment standard has changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Background: PubMed 27339115Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
- Individual participant dataSharing planned: No
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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.
Tanja Langsenlehner, MD principal investigator
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated radiotherapy in people with Prostate Cancer and Radiotherapy Side Effect, run by Medical University of Graz at 1 site in Austria.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
The study was stopped early (reason given: Treatment standard has changed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute radiation - induced toxicity (time frame: Measurement at the last 1 day of radiotherapy). The study lists 2 primary outcomes in all. 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 NCT04535908, 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 3 Oct 2022.