Prostate CancerHypo-M1NCT04612907
Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
A study testing Moderate hypo-fractionation and Ultra-hypo-fractionation in people with Prostate Cancer and Radiotherapy Side Effect, run by Umeå University at 1 site in Sweden.
Trial summary
de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Radiotherapy Side Effect, Metastatic Cancer
- What is being tested?
- Moderate hypo-fractionation and Ultra-hypo-fractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSweden
- Study dates
- 31 Oct 2022to 30 Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Signed Informed Consent
- Histological confirmed prostate cancer
- Indication for early palliative radiation therapy of low burden metastatic prostate cancer. Low burden as defined by modified CHAARTED trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes
- baseline E-PROM
Who cannot join
- High burden metastatic prostate cancer including all with visceral mets.
- Unable to comply with study procedures.
- Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy
- Radiation treatment start later than nine months after the prostate cancer diagnosis.
- Severe micturition problems, IPSS > 20 ( International Prostate Symptom Score)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Cancercenter University hospital of Umeå
Umeå, 90596
Camilla Thellenberg Karlsson, MD, PhD, +46907853296, camilla.thellenberg@umu.se
Karin Söderkvist, MD, PhD, +46907850000, karin.soderkvist@umu.se
About this study
Official title: A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.
Read the detailed description
Patients with de Novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. The internationally accepted fractionation schedule is 3 Gy (Gray) x 19-20 over a course of 4 weeks.
There is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. We will test if the schedule of 6.1Gy x 6 compares to standard of 3 Gy x 19 with regard to patient reported side-effects.
- Conditions
- Prostate Cancer, Radiotherapy Side Effect, Metastatic Cancer
- Being tested
- Moderate hypo-fractionation, Ultra-hypo-fractionation
- Keywords
- Metastatic prostate cancer radiotherapy primary tumor
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate hypo-fractionationRadiation
Patients will receive four weeks of radiotherapy
Ultra-hypo-fractionationRadiation
Patients will receive two and a half weeks of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Moderate hypo-fractionation | Active comparator | Radiotherapy to the prostate delivered in 3Gy fractions x 19 Receives: Radiation: Moderate hypo-fractionation |
| Ultra hypo-fractionation | Experimental | Radiotherapy to the prostate delivered in 6.1Gy fractions x 6 Receives: Radiation: Ultra-hypo-fractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks
Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS (Prostate Cancer Symptom Scale) bother score for urinary tract will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
Measured: 8 weeks
Toxicity as scored by PROM at 8 weeks
Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS bother score for bowel will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
Measured: 8 weeks
Secondary outcomes (1)
Failure free survival
To evaluate the proportion of patients that are failure free at 12 and 36 months, failure free survival (FFS)
Measured: 12 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start31 Oct 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to one of two treatment fractionations of radiotherapy
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camilla of T Karlsson, Principal investigator, Cancercentrum Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612907
- Sponsor's protocol ID
- Hypo-M1 1.0
- Acronym
- Hypo-M1
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT04612907
- Acronym / sponsor ID
- Hypo-M1 / Hypo-M1 1.0
- Conditions
- Prostate Cancer, Radiotherapy Side Effect, Metastatic Cancer
- Keywords
- Metastatic prostate cancer radiotherapy primary tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 3 Nov 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.
de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.
Detailed description
Patients with de Novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. The internationally accepted fractionation schedule is 3 Gy (Gray) x 19-20 over a course of 4 weeks.
There is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. We will test if the schedule of 6.1Gy x 6 compares to standard of 3 Gy x 19 with regard to patient reported side-effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to one of two treatment fractionations of radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Moderate hypo-fractionation | Active comparator | Radiation: Moderate hypo-fractionationRadiotherapy to the prostate delivered in 3Gy fractions x 19 |
| Ultra hypo-fractionation | Experimental | Radiation: Ultra-hypo-fractionationRadiotherapy to the prostate delivered in 6.1Gy fractions x 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed Informed Consent
- Histological confirmed prostate cancer
- Indication for early palliative radiation therapy of low burden metastatic prostate cancer. Low burden as defined by modified CHAARTED trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes
- baseline E-PROM
Key exclusion criteria (5 listed)
- High burden metastatic prostate cancer including all with visceral mets.
- Unable to comply with study procedures.
- Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy
- Radiation treatment start later than nine months after the prostate cancer diagnosis.
- Severe micturition problems, IPSS > 20 ( International Prostate Symptom Score)
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 |
|---|---|---|
| Moderate hypo-fractionationPatients will receive four weeks of radiotherapy | Radiation | Moderate hypo-fractionation |
| Ultra-hypo-fractionationPatients will receive two and a half weeks of radiotherapy | Radiation | Ultra hypo-fractionation |
Primary outcome
Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks
Time frame: 8 weeks
Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS (Prostate Cancer Symptom Scale) bother score for urinary tract will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
Toxicity as scored by PROM at 8 weeks
Time frame: 8 weeks
Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS bother score for bowel will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
1 secondary outcome
Failure free survival
Time frame: 12 months, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Camilla of T Karlsson principal investigator
Cancercentrum Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate hypo-fractionation and Ultra-hypo-fractionation in people with Prostate Cancer and Radiotherapy Side Effect, run by Umeå University at 1 site in Sweden.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Feb 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla Thellenberg Karlsson, MD, PhD (+46 90 785 3296, camilla.thellenberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks (time frame: 8 weeks). 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?
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 28 Feb 2024.