Prostate CancerBRADNCT01842750
The Use of Rectal Balloons in Radical Pelvic Radiotherapy - a Feasibility Study
A study testing Endorectal Balloon insertion in people with Prostate Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to test the hypothesis that insertion of an endorectal balloon into a patient receiving radical prostate radiotherapy by treatment radiographers is feasible without the patient experiencing undue discomfort. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Endorectal Balloon insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Dec 2014
- 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
- Age greater than or equal to 18 years
- ECOG performance status 0-2 (Patients with PS-2 as a result of comorbidity will be excluded).
- Patients with histologically confirmed diagnosis of prostate adenocarcinoma
- Patients who are going to undergo treatment with radical radiotherapy for prostate cancer.
- Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
- Patients must be able to comply with trial requirements.
Who cannot join
- Patients must not have a history of previous bowel surgery involving the rectum or anus.
- Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial, as well as any other serious uncontrolled medical condition.
- Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
- Pre-existing anorectal disease, e.g. Haemorrhoids, active bleeding, anal irritation, inflammatory bowel disease.
- Patients who are unable to give consent.
- Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study.
- Prior pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Christie Hospital NHS Foundation Trust
Manchester, Manchester, M20 4BX
Julie Stratford, 01614463506, julie.stratford@christie.nhs.uk
Julie Stratford
About this study
This study aims to test the hypothesis that insertion of an endorectal balloon into a patient receiving radical prostate radiotherapy by treatment radiographers is feasible without the patient experiencing undue discomfort. In addition this study will test the hypotheses that insertion of the rectal balloon prior to radiotherapy delivery stabilises rectal volume during radiotherapy treatment and minimises organ motion within the pelvis.
- Conditions
- Prostate Cancer
- Being tested
- Endorectal Balloon insertion
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endorectal Balloon insertionDevice
| Study group | Role | What they receive |
|---|---|---|
| Endorectal Balloon insertion | Experimental | A cone Beam scan will be performed prior to balloon insertion and then again with balloon in situ. The scans will be compared to see if the organs are stabilised. Questionnaires will be completed by the radiographer and the patient. Receives: Device: Endorectal Balloon insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
The primary aim is to determine whether the balloon insertion is tolerated throughout treatment. The principle outcome measure is the percentage of patients who tolerate the endorectal balloon throughout treatment.
Measured: Patients will be assessed for 4 weeks throughout radiotherapy treatment
Secondary outcomes (4)
rectal volume
Rectal volume stability will be determined by comparing the rectal volume for scans with the endorectal balloon(ERB)in situ to scans without the ERB in situ
Measured: patient scans will be reviewed over 4 weeks of radiotherapy
Assessment of planning target volume (PTV) coverage
PTV coverage and an assessment of prostate shape and position between the weekly imaging scans with the balloon in situ will be compared with the position of the prostate and PTV coverage on the original planning scan with the balloon in situ
Measured: patients will be reviewed across a 4 week radiotherapy treatment period.
Rectal wall sparing
Rectal wall sparing will be assessed by comparing the estimated dose determined from the imaging scans with the ERB in situ and not in situ against the planned dose from the radiotherapy planning scan
Measured: patients reviewed across 4 weeks of radiotherapy treatment
Acute toxicity
Acute toxicity according to CTCAE v. 4.0. This will record any reasons why balloon insertion is not possible for review.
Measured: patients toxicity will be assessed over 4 weeks of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014 (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.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Stratford, The Christie NHS Foundation Trust
- Investigators
- Julie Stratford, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842750
- Sponsor's protocol ID
- 11_RADIO_101
- Acronym
- BRAD
- Status last verified
- Jun 2014
- First submitted
- 17 Apr 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Rectal Balloons in Radical Pelvic Radiotherapy - a Feasibility Study
- ClinicalTrials.gov ID
- NCT01842750
- Acronym / sponsor ID
- BRAD / 11_RADIO_101
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 30 Apr 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.
This study aims to test the hypothesis that insertion of an endorectal balloon into a patient receiving radical prostate radiotherapy by treatment radiographers is feasible without the patient experiencing undue discomfort. In addition this study will test the hypotheses that insertion of the rectal balloon prior to radiotherapy delivery stabilises rectal volume during radiotherapy treatment and minimises organ motion within the pelvis.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endorectal Balloon insertion | Experimental | Device: Endorectal Balloon insertionA cone Beam scan will be performed prior to balloon insertion and then again with balloon in situ. The scans will be compared to see if the organs are stabilised. Questionnaires will be completed by the radiographer and the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- ECOG performance status 0-2 (Patients with PS-2 as a result of comorbidity will be excluded).
- Patients with histologically confirmed diagnosis of prostate adenocarcinoma
- Patients who are going to undergo treatment with radical radiotherapy for prostate cancer.
- Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
Key exclusion criteria (7 listed)
- Patients must not have a history of previous bowel surgery involving the rectum or anus.
- Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial, as well as any other serious uncontrolled medical condition.
- Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
- Pre-existing anorectal disease, e.g. Haemorrhoids, active bleeding, anal irritation, inflammatory bowel disease.
- Patients who are unable to give 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 |
|---|---|---|
| Endorectal Balloon insertion | Device | Endorectal Balloon insertion |
Primary outcome
Tolerability
Time frame: Patients will be assessed for 4 weeks throughout radiotherapy treatment
The primary aim is to determine whether the balloon insertion is tolerated throughout treatment. The principle outcome measure is the percentage of patients who tolerate the endorectal balloon throughout treatment.
4 secondary outcomes
rectal volume
Time frame: patient scans will be reviewed over 4 weeks of radiotherapy
Assessment of planning target volume (PTV) coverage
Time frame: patients will be reviewed across a 4 week radiotherapy treatment period.
Rectal wall sparing
Time frame: patients reviewed across 4 weeks of radiotherapy treatment
Acute toxicity
Time frame: patients toxicity will be assessed over 4 weeks of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Julie Stratford principal investigator
The Christie 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 Endorectal Balloon insertion in people with Prostate Cancer, run by The Christie 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 6 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: status not confirmed, as of the sponsor's last update on 30 Jul 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Stratford (01614463506, julie.stratford@christie.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability (time frame: Patients will be assessed for 4 weeks throughout radiotherapy treatment). 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 30 Jul 2014.