Prostate CancerPhase 2HypofractionNCT01921803
Hypofractionated Radiotherapy as Primary Therapy for Prostate Cancer
A Phase 2 study testing hypofractionation in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
External beam radiotherapy (RT) is one of the standard curative treatment options for patients with prostate cancer (PC). Several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- hypofractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2013to 14 Jul 2020
- Phase
- Phase 2
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with T1-4 N0 M0 prostate cancer
Who cannot join
- other no skin cancer diagnosed within 5 years prior to enrolment
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypofractionated Radiotherapy as Primary Therapy for Prostate Cancer: Randomised Trial Comparing Toxicity Between 2 Different Hypofractionated Schedules
External beam radiotherapy (RT) is one of the standard curative treatment options for patients with prostate cancer (PC). Several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks. The sensitivity of different tissues to fractionation changes can be quantified through the α/β ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with both external beam RT and brachytherapy has led to the hypothesis that the α/β ratio of PC is lower than for most other tumors and approaches a value characteristic of late responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the α/β ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of patient convenience and treatment cost are obvious. There is level I evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation RT schedules.
Results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. In this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. The study will be performed in 2 stages. For stage 1, sample size was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI complications with an expected rate of 25%. When including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.
- Conditions
- Prostate Cancer
- Being tested
- hypofractionation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 16 fractions à rato of 4 fractions a week over 4 weeks Receives: Radiation: hypofractionation |
| Arm 2 | Experimental | 25 fractions à rato of 5 fractions a week over 5 weeks Receives: Radiation: hypofractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute and early late toxicity
A maximal incidence of 40% of Grade 2 gastro-intestinal (GI) toxicity is allowed. Evaluation of difference in grade 2 and 3 GI toxicity.
Measured: pre radiotherapy
acute and early late toxicity
Measured: 1 month after radiotherapy
acute and early late toxicity
Measured: 3 months after radiotherapy
acute and early late toxicity
Measured: 6 months after radiotherapy
acute and early late toxicity
Measured: 9 months after radiotherapy
acute and early late toxicity
Measured: 12 months after radiotherapy
acute and early late toxicity
Measured: 18 months radiotherapy
acute and early late toxicity
Measured: 24 months radiotherapy
Secondary outcomes (2)
change in quality of life
- EORTC QLQ-C30 and EORTC QLQ-PR25
- EQ-5D-5L
Measured: from start to 24 months after radiotherapy
cost effectiveness
Measured: 24 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 posted13 Aug 2013 (estimated)
- Study start1 Aug 2013
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
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 University Hospital, GhentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Fonteyne, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921803
- Sponsor's protocol ID
- 2013/380
- Acronym
- Hypofraction
- Status last verified
- Dec 2022
- First submitted
- 30 Jul 2013
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Fonteyne V, Sarrazyn C, Swimberghe M, De Meerleer G, Rammant E, Vanderstraeten B, Vanpachtenbeke F, Lumen N, Decaestecker K, Colman R, Villeirs G, Ost P. 4 Weeks Versus 5 Weeks of Hypofractionated High-dose Radiation Therapy as Primary Therapy for Prostate Cancer: Interim Safety Analysis of a Randomized Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):866-870. doi: 10.1016/j.ijrobp.2017.12.016. Epub 2017 Dec 19.
PubMed 29485064
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiotherapy as Primary Therapy for Prostate Cancer: Randomised Trial Comparing Toxicity Between 2 Different Hypofractionated Schedules
- ClinicalTrials.gov ID
- NCT01921803
- Acronym / sponsor ID
- Hypofraction / 2013/380
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 13 Aug 2013 (estimated)
- 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.
External beam radiotherapy (RT) is one of the standard curative treatment options for patients with prostate cancer (PC). Several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks. The sensitivity of different tissues to fractionation changes can be quantified through the α/β ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with both external beam RT and brachytherapy has led to the hypothesis that the α/β ratio of PC is lower than for most other tumors and approaches a value characteristic of late responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the α/β ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of patient convenience and treatment cost are obvious. There is level I evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation RT schedules.
Results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. In this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. The study will be performed in 2 stages. For stage 1, sample size was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI complications with an expected rate of 25%. When including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: hypofractionation16 fractions à rato of 4 fractions a week over 4 weeks |
| Arm 2 | Experimental | Radiation: hypofractionation25 fractions à rato of 5 fractions a week over 5 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with T1-4 N0 M0 prostate cancer
Key exclusion criteria (2 listed)
- other no skin cancer diagnosed within 5 years prior to enrolment
- no 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 |
|---|---|---|
| hypofractionation | Radiation | Arm 1, Arm 2 |
Primary outcome
acute and early late toxicity
Time frame: pre radiotherapy
A maximal incidence of 40% of Grade 2 gastro-intestinal (GI) toxicity is allowed. Evaluation of difference in grade 2 and 3 GI toxicity.
acute and early late toxicity
Time frame: 1 month after radiotherapy
acute and early late toxicity
Time frame: 3 months after radiotherapy
acute and early late toxicity
Time frame: 6 months after radiotherapy
acute and early late toxicity
Time frame: 9 months after radiotherapy
acute and early late toxicity
Time frame: 12 months after radiotherapy
acute and early late toxicity
Time frame: 18 months radiotherapy
acute and early late toxicity
Time frame: 24 months radiotherapy
2 secondary outcomes
change in quality of life
Time frame: from start to 24 months after radiotherapy
cost effectiveness
Time frame: 24 months after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 29485064Fonteyne V, Sarrazyn C, Swimberghe M, De Meerleer G, Rammant E, Vanderstraeten B, Vanpachtenbeke F, Lumen N, Decaestecker K, Colman R, Villeirs G, Ost P. 4 Weeks Versus 5 Weeks of Hypofractionated High-dose Radiation Therapy as Primary Therapy for Prostate Cancer: Interim Safety Analysis of a Randomized Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):866-870. doi: 10.1016/j.ijrobp.2017.12.016. Epub 2017 Dec 19.
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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.
Valerie Fonteyne principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypofractionation in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 22 Dec 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and early late toxicity (time frame: pre radiotherapy). The study lists 8 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 NCT01921803, 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 22 Dec 2022.