Prostate CancerBIOPROP20NCT02125175
BIOPROP20: Biologically Optimised IMRT for Prostate Radiotherapy Hypofractionated Radiotherapy With Intra-prostatic Boosts to Tumour Nodules in Men With Intermediate and High Risk Prostate Cancer
A study testing Hypofractionated IMRT boost Radiotherapy in people with Prostate Cancer, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
High dose radiotherapy is a very effective treatment for prostate cancer. However, there is an increased risk of side effects compared to lower dose radiotherapy. This study will investigate the use of dose painting radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hypofractionated IMRT boost Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Sep 2019
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- NCCN intermediate/high risk disease and estimated risk of lymph node involvement 15 - 40%*
- MRI stage T2a-T4 N0M0
- Age 18-80 years
- Normal blood count (Hb >11g/dl, WBC > 4000/mm3, platelets >100,000/mm3)
- WHO performance status 0 or 1
- Fully informed written consent
- Risk of pelvic lymph node involvement = (Gleason score - 6) x 10 + 2/3 PSA
Who cannot join
- Prior radiotherapy to the prostate or pelvis
- Prior hormone therapy or radical prostatectomy
- Total hip replacement
- Clinically significant inflammatory bowel disease
- Contraindication to have diagnostic MRI scans
- Unable to have a general anaesthetic
- Anti-coagulant therapy which cannot be temporarily stopped
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, CH63 4JY
About this study
High dose radiotherapy is a very effective treatment for prostate cancer. However, there is an increased risk of side effects compared to lower dose radiotherapy. This study will investigate the use of dose painting radiotherapy. Dose painting radiotherapy administers a high dose of radiotherapy to areas of cancer inside the prostate and a lower (standard) dose to the rest of the prostate. This may improve control of the cancer without increasing the side effects. The radiotherapy is given in 20 doses, called fractions.
Read the detailed description
For patients with prostate cancer which has not spread, the typical treatment is hormone therapy and radiotherapy.
It is possible to identify areas within the prostate which contain a significant amount of cancer with functional MRI or with 18F choline PET CT scans. These areas are called Dominant Intraprostastic Lesions 'DILs'. Targeted prostate biopsies help to confirm scan results. The radiotherapy dose to the DILs is increased, whilst the rest of the prostate is treated with the standard dose. This technique is called dose painting or 'boost' Intensity Modulated Radiotherapy Treatment (IMRT).
IMRT is given in 37 treatment doses called fractions, once a day for about 8 weeks. A hypofractionated schedule is the administration of the total radiotherapy treatment over a smaller number of fractions, at a higher dose per fraction. Recent evidence suggests that the idea of using a 'hypofractionated' treatment schedule is better and more convenient with a similar number of side effects as a regular schedule.
In the study, 50 patients with intermediate/high risk prostate cancer suitable and fit for radical radiotherapy will be recruited. The patients undergo a staging functional MRI scan, fiducial marker insertion (required for image guided radiotherapy) and hormone therapy as per standard of care treatment. The choline PET CT scan and targeted prostate biopsies are optional. They are useful if the MRI is difficult to interpret and will be offered to patients if they are felt to be appropriate by the clinician. After 2 months hormone therapy (standard protocol) patients have a CT /MRI planning scan and undergo IMRT with 20 treatments (fractions).The patient will then be followed up until 24 months after they started radiotherapy treatment.
The main aim is to assess the side effects related to the bladder and bowel at 18 weeks (acute toxicity) after starting hypofractionated IMRT.
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated IMRT boost Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated IMRT boost RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated IMRT boost Radiotherapy | Experimental | Not described Receives: Radiation: Hypofractionated IMRT boost Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute bladder and bowel toxicity (NCI CTCAE v 4.0 and RTOG) at 18 weeks after the commencement of radiotherapy treatment
Measured: 18 weeks
Secondary outcomes (2)
The success rate of producing dose painted IMRT plans which fulfill the dose-volume constraints as specified for the prostate and for the normal tissues
Measured: 3 years
Late bladder and bowel toxicity (NCI CTCAE v4) at 2 years
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabel Syndikus, MD, Principal investigator, The Clatterbridge Cancer Centre NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125175
- Sponsor's protocol ID
- RDD547
- Acronym
- BIOPROP20
- Status last verified
- May 2019
- First submitted
- 17 Apr 2014
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chatterjee R, Chan J, Mayles H, Cicconi S, Syndikus I. Long-term Results of Hypofractionated Radiotherapy With Intra-prostatic Boosts in Men With Intermediate- and High-risk Prostate Cancer: A Phase II Trial. Clin Oncol (R Coll Radiol). 2024 Dec;36(12):e473-e482. doi: 10.1016/j.clon.2024.08.011. Epub 2024 Aug 22.
PubMed 39242247Onjukka E, Uzan J, Baker C, Howard L, Nahum A, Syndikus I. Twenty Fraction Prostate Radiotherapy with Intra-prostatic Boost: Results of a Pilot Study. Clin Oncol (R Coll Radiol). 2017 Jan;29(1):6-14. doi: 10.1016/j.clon.2016.09.009. Epub 2016 Sep 29.
PubMed 27692920
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOPROP20: Biologically Optimised IMRT for Prostate Radiotherapy Hypofractionated Radiotherapy With Intra-prostatic Boosts to Tumour Nodules in Men With Intermediate and High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02125175
- Acronym / sponsor ID
- BIOPROP20 / RDD547
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 29 Apr 2014 (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.
High dose radiotherapy is a very effective treatment for prostate cancer. However, there is an increased risk of side effects compared to lower dose radiotherapy. This study will investigate the use of dose painting radiotherapy. Dose painting radiotherapy administers a high dose of radiotherapy to areas of cancer inside the prostate and a lower (standard) dose to the rest of the prostate. This may improve control of the cancer without increasing the side effects. The radiotherapy is given in 20 doses, called fractions.
Detailed description
For patients with prostate cancer which has not spread, the typical treatment is hormone therapy and radiotherapy.
It is possible to identify areas within the prostate which contain a significant amount of cancer with functional MRI or with 18F choline PET CT scans. These areas are called Dominant Intraprostastic Lesions 'DILs'. Targeted prostate biopsies help to confirm scan results. The radiotherapy dose to the DILs is increased, whilst the rest of the prostate is treated with the standard dose. This technique is called dose painting or 'boost' Intensity Modulated Radiotherapy Treatment (IMRT).
IMRT is given in 37 treatment doses called fractions, once a day for about 8 weeks. A hypofractionated schedule is the administration of the total radiotherapy treatment over a smaller number of fractions, at a higher dose per fraction. Recent evidence suggests that the idea of using a 'hypofractionated' treatment schedule is better and more convenient with a similar number of side effects as a regular schedule.
In the study, 50 patients with intermediate/high risk prostate cancer suitable and fit for radical radiotherapy will be recruited. The patients undergo a staging functional MRI scan, fiducial marker insertion (required for image guided radiotherapy) and hormone therapy as per standard of care treatment. The choline PET CT scan and targeted prostate biopsies are optional. They are useful if the MRI is difficult to interpret and will be offered to patients if they are felt to be appropriate by the clinician. After 2 months hormone therapy (standard protocol) patients have a CT /MRI planning scan and undergo IMRT with 20 treatments (fractions).The patient will then be followed up until 24 months after they started radiotherapy treatment.
The main aim is to assess the side effects related to the bladder and bowel at 18 weeks (acute toxicity) after starting hypofractionated IMRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated IMRT boost Radiotherapy | Experimental | Radiation: Hypofractionated IMRT boost Radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed adenocarcinoma of the prostate
- NCCN intermediate/high risk disease and estimated risk of lymph node involvement 15 - 40%*
- MRI stage T2a-T4 N0M0
- Age 18-80 years
- Normal blood count (Hb >11g/dl, WBC > 4000/mm3, platelets >100,000/mm3)
Key exclusion criteria (7 listed)
- Prior radiotherapy to the prostate or pelvis
- Prior hormone therapy or radical prostatectomy
- Total hip replacement
- Clinically significant inflammatory bowel disease
- Contraindication to have diagnostic MRI scans
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 IMRT boost Radiotherapy | Radiation | Hypofractionated IMRT boost Radiotherapy |
Primary outcome
Acute bladder and bowel toxicity (NCI CTCAE v 4.0 and RTOG) at 18 weeks after the commencement of radiotherapy treatment
Time frame: 18 weeks
2 secondary outcomes
The success rate of producing dose painted IMRT plans which fulfill the dose-volume constraints as specified for the prostate and for the normal tissues
Time frame: 3 years
Late bladder and bowel toxicity (NCI CTCAE v4) at 2 years
Time frame: 2 Years
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 29 Oct 2019.
- Derived from this study: PubMed 39242247Chatterjee R, Chan J, Mayles H, Cicconi S, Syndikus I. Long-term Results of Hypofractionated Radiotherapy With Intra-prostatic Boosts in Men With Intermediate- and High-risk Prostate Cancer: A Phase II Trial. Clin Oncol (R Coll Radiol). 2024 Dec;36(12):e473-e482. doi: 10.1016/j.clon.2024.08.011. Epub 2024 Aug 22.
- Derived from this study: PubMed 27692920Onjukka E, Uzan J, Baker C, Howard L, Nahum A, Syndikus I. Twenty Fraction Prostate Radiotherapy with Intra-prostatic Boost: Results of a Pilot Study. Clin Oncol (R Coll Radiol). 2017 Jan;29(1):6-14. doi: 10.1016/j.clon.2016.09.009. Epub 2016 Sep 29.
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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.
Isabel Syndikus, MD principal investigator
The Clatterbridge Cancer Centre NHS Foundation Trust
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 IMRT boost Radiotherapy in people with Prostate Cancer, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
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 7 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 29 Oct 2019. 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 United Kingdom. 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 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 bladder and bowel toxicity (NCI CTCAE v 4.0 and RTOG) at 18 weeks after the commencement of radiotherapy treatment (time frame: 18 weeks). 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 NCT02125175, which also lists 2 linked publications.
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 29 Oct 2019.