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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endorectal Balloon insertion | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Patients will be assessed for 4 weeks throughout radiotherapy treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | patient scans will be reviewed over 4 weeks of radiotherapy |
| Assessment of planning target volume (PTV) coverage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Stratford | Contact | 01614463506 | julie.stratford@christie.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Julie Stratford | The Christie NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christie Hospital NHS Foundation Trust | Recruiting | Manchester | Manchester | M20 4BX | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| 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 | 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. | patients toxicity will be assessed over 4 weeks of radiotherapy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |