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The observation of radiotherapy doses achieved when planning on an empty bladder versus a full Bladder for prostate radiotherapy treatment.

An observational prospective study comparing radiotherapy treatment plans on patients with a full bladder and empty bladder who are diagnosed with Prostate Cancer.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624001297516
Enrollment
20
Registered
2024-10-25
Start date
2024-12-02
Completion date
2026-01-01
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim: The aim of this study is to improve the patient experience in the future, whilst lowering the risk of planning errors, treatment errors, and the need for replanning. Who is it for: You may be eligible for this study if you are male or female age 18 or older with confirmd prostate only or prostate with SVs. Study details: Participants will receive one radiotherapy planning scan session as per the current standard of care. The extra Computed Tomography scan will be completed on the same day if the patient agrees to participate in the study. the extra scan will take approximately 20 minutes and will deliver an extra 7.6 mSv of dose. It is hoped that findings from this study will be a lower risk of patients having to miss their treatment due to the inability to reproduce the bladder size from initial planning scan. Patients will be in the department for a smaller amount of time, and it will have less of a knock-on effect to other patients receiving treatment.

Interventions

1. Empty bladder V full Bladder for prostate radiotherapy _ GenesisCare National Patient Information and Consent Form (PICF) will be given to the patients. They will have the opportunity to read the information in their own time regarding the procedure, time taken to be apart of the study and also the collection of data and any risks to the patient as part of the study. Once happy the patient can consent to the procedure if they wish to participate. 2. Radiation Oncologists will go thoroughly as

1. Empty bladder V full Bladder for prostate radiotherapy _ GenesisCare National Patient Information and Consent Form (PICF) will be given to the patients. They will have the opportunity to read the information in their own time regarding the procedure, time taken to be apart of the study and also the collection of data and any risks to the patient as part of the study. Once happy the patient can consent to the procedure if they wish to participate. 2. Radiation Oncologists will go thoroughly assess each patient who is intended for the study. They will explain the procedure and other information associated to the study. The Radiation Oncologists have a wealth of experience in this field and have submitted their up-to-date CV's to Human Research Ethics Committee (HREC). Radiation Therapists involved in the study will explain the procedure in detail with regards to the Computed Tomography scans needed. the Radiation Therapists have a wealth of experience in this field and have submitted their up-to-date CV's to HREC. 3. The mode of delivery will be face to face. The radiotherapy planning team will use the empty bladder scan and the full bladder scan to create two prostate radiotherapy plans. In doing so, differences and similarities in doses to the prostate will be observed and recorded. The use of the full bladder plan will be used as the usual standard of car for the patients treatment. For the preparation of the first CT scan, we will follow our usual full bladder protocol. We will ensure an optimally full bladder, which the patient will have to achieve during each radiotherapy treatment, which is our current standard of care. Following the first CT scan the patient will be asked to immediately empty their bladder. The patient can take as long as they need to fully empty their bladder and after doing so will then have another CT scan whilst their bladder is empty. This scan in not our current standard of care. We will use this scan to help with the planning comparison. 4. The patient will come for one radiotherapy planning scan session as per the current standard of care. The extra Computed Tomography scan will be completed on the same day if the patient agrees to participate in the study. The extra scan will take approximately 20 minutes. This research study involves exposure to a small amount of radiation. As part of everyday living, everyone is exposed to naturally occurring background radiation and receives a dose of about 2 millisieverts (mSv) each year. The effective dose from this study is about 9.5 mSv. The dose from this study is comparable to that received from many diagnostic medical x-ray and nuclear medicine procedures. At this dose level, no harmful effects of radiation have been demonstrated as any effect is too small to measure. The study team will use the data collected and observe the data over a 12 month period. 5. The study will be performed at GenesisCare Southport and GenesisCare Tugun in QLD.

Sponsors

GenesisCare
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Prostate only and Prostate with SVs, confirmed by Histopathology • 18 years + • Male • No previous Radiotherapy • Curative intent • Signed written and informed consent • Willingness to comply with study procedure

Exclusion criteria

• Patients who cannot empty their bladder sufficiently enough. Or whether they have a sensation of wanting to empty or if they double void on a regular occurrence. • Previous radiotherapy to the prostate

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026