None listed
Conditions
Brief summary
This is a non-randomized cohort study. The purpose of this trial is to compare the side effect profile and their effects on patients treated with 3 different techniques of delivery of curative radiotherapy for localized prostate cancer.We will collect a series of patient-based urinary, bowel, and sexual function scores using validated assessment tools before treatment, 6 weeks and then at intervals after treatment and correlate the results of that with objective, quantitative measurement of patients’ bladder and bowel function using physiologic laboratory tools. This will help us to determine comparative functional effects and understand whether there is a mechanical / physiological explanation for patients’ side effects.
Interventions
Different forms of Radiotherapy (RT) treatment are offered to patients with localised prostate cancer, depending on the stage of the disease and patients' medical conditions: either High-Dose-Rate RT plus EBRT for 5 weeks, seed brachytherapy implant as a day only procedure. The functional outcome
Different forms of Radiotherapy (RT) treatment are offered to patients with localised prostate cancer, depending on the stage of the disease and patients' medical conditions: either High-Dose-Rate RT plus EBRT for 5 weeks, seed brachytherapy implant as a day only procedure. The functional outcomes after either form of brachytherapy will be compared with EBRT alone (control)
Sponsors
Department of radiation oncology, St George Hospital, Kogarah 2217
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
All Study groups:· Histologically confirmed adenocarcinoma of the prostate eligible for curative treatment · N0M0 i.e. cancer confined to the prostate only with no lymph nodes or other organ involvement· Good performance status (ECOG 0-1)· Patient is mentally, physically and geographically capable of undergoing treatment and follow-up. No significant co-morbidity limiting life expectancy to < 5 years· No diabetes mellitus or other significant neurological disorders that may affect pelvic nerve function· No other malignancy diagnosed within the last 5 years, except non-melanotic skin cancers· Informed consent signed.Brachytherapy groups:Specific Inclusion criteria· No previous TURP (surgical urethral scraping)· Prostate volume < 50cc for LDR and < 75cc prior to hormonal therapy for HDR· Stage T1c to T2a for LDR (i.e. prostate cancer confined to 1 lobe of prostate) and stage T1c-T4 for HDR provided the tumour volumes are encompassable within a radiation portal.· Able to undergo general anaesthetics and obtain dorso-lithortomy position· PSA <10ng/ ml for LDR· No bilateral total hip replacement as this interferes with obtaining CT images for radiotherapy planning (unless pre-procedure CT performed demonstrates adequate visualisation of the prostate target volume)· Ability to assume dorso-lithotomy position· No bleeding disorders or on anti-coagulations that increases patients’ risk of intra-operative bleeding.
Exclusion criteria
Prior radiation therapy to the pelvis. Poor performance status (ECOG 2 or above).
Outcome results
None listed