None listed
Conditions
Brief summary
The study will be assessing whether rectal side effects from radiation treatment can be reduced, by using a spacing agent between the rectum and prostate gland. The agent is a gel, which is injected in the space between the prostate gland and rectum, in order to increase separation between these two structures. The idea is that the rectal radiation dose and hence side effects, will be reduced by the increased separation.
Interventions
Single transperineal injection of polyethylene glycol (10-15ml) in the space posterior to Denonvillier's fascia, and anterior to the rectum, under general anaesthetic. Measurement of prostate-rectum separation, and rectal radiation dose in the presence of the polyethylene glycol spacer. There are four patients groups who wo will be considered for the study (2 prostate seed brachytherapy groups, a high dose rate brachytherapy group, and an external beam radiotherapy group). All four patient group
Single transperineal injection of polyethylene glycol (10-15ml) in the space posterior to Denonvillier's fascia, and anterior to the rectum, under general anaesthetic. Measurement of prostate-rectum separation, and rectal radiation dose in the presence of the polyethylene glycol spacer. There are four patients groups who wo will be considered for the study (2 prostate seed brachytherapy groups, a high dose rate brachytherapy group, and an external beam radiotherapy group). All four patient groups will receive the same intervention as part of te study (PEG hydrogel insertion and measurement of prostate-rectum separation and rectal radiation dose). The type of radiotherapy they receive will be tailored to their disease and own circumstances and is independent of their participation in the study.
Sponsors
St George Hospital Cancer Care Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Histopathologically confirmed, localised prostate cancer, fit for prostate brachytherapy or dose escalated external beam radiotherapy with iducial marker localisation, fit for general anaesthetic. No prior history of bleeding disorder, prior transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), bladder neck resection, perirectal/perianal abscess, rectal/anal fissure. No prior history of prostate or pelvic radiotherapy. Able to provide written informed consent.
Exclusion criteria
Previous history of bleeding disorder, prior TURP, TUIP, bladder neck resection, perirectal/perianal abscess, rectal/anal fissure. Prior history of prostate or pelvic radiotherapy. Unfit for general anaesthetic. Unable to provide written informed consent.
Outcome results
None listed