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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 001234
ACTR Number: ACTRN12606000157572
Trial Status: Registered
Date Submitted: 26/04/2006
Date Registered: 3/05/2006

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Public title: Prospective Outcomes-analysis for localised Prostate Adenocarcinoma after Radiotherapy Treatment
ANZCTR registration title: Prospective Outcomes-analysis for localised Prostate Adenocarcinoma after Radiotherapy Treatment, including external beam radiotherapy alone, high dose rate brachytherapy in combination with external beam radiotherapy or seed implant brachytherapy
Secondary ID: 
UTN:
Trial acronym: POP-ART

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Health condition(s) or problem(s) studied:
Prostate cancer 
Condition category: Condition code:
Cancer Prostate 

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Description of intervention(s) / exposure: 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)
Intervention code:Treatment devices 
Comparator / control treatment: External beam RT (EBRT) alone
Control group: Active

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Primary outcome 1:Anorectal Function following curative radiotherapy 
Timepoint:Measured at baseline, then 6 weeks and 12 months after radiotherapy. 
Primary outcome 2:Lower urinary tract function following curative radiotherapy 
Timepoint:Measured at baseline, then 6 weeks and 12 months after radiotherapy. 
Primary outcome 3:Quality of life following curative radiotherapy 
Timepoint:Measured at baseline, then 6 weeks and 12 months after radiotherapy. 
Secondary outcome 1:Sexual function 
Timepoint:At baseline, 6 weeks and 12 months after treatment of radiotherapy. 
Secondary outcome 2:Relapse-free survival 
Timepoint:At 2 years after treatment. 

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Key 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.
Minimum Age: 40 Years
Maximum Age: 80 Years
Gender: Males
Healthy volunteers? No
Key exclusion criteria: Prior radiation therapy to the pelvis. Poor performance status (ECOG 2 or above).

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Open (masking not used)
Assignment: Parallel
Other design features (specify): Functional studies at baseline, 6 weeks and 12 months after radiotherapy
Type of endpoint(s): Safety

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Phase Phase 4
Anticipated or actual date of first participant enrolement: 27/04/2006
Target sample size: 78
Recruitment status: Open to recruitment

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Funding source:Hospital 
Name:Department of radiation oncology, St George Hospital 
Address: 
Country:Australia 
Primary sponsor: Hospital
Name: Department of radiation oncology, St George Hospital, Kogarah 2217
Address:
Country: Australia
Secondary sponsor:None 
Name:Nil 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:South Eastern Sydney Health Area 
Address: 
Country:Australia 
Date of approval:11/04/2006 
HREC Number:06/28 Ho 
Countries of recruitment:Australia 
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.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Dr Annie Ho
Address: Department of Radiation Oncology The St George Hospital Gray Street Kogarah NSW 2217
Country: Australia
Tel: +61 2 93501111
Fax: +61 2 93503958
Email: hoan@sesahs.nsw.gov.au

Contact person for scientific queries
Name: Dr Annie Ho and Dr Joseph Bucci
Address: Department of Radiation Oncology The St George Hospital Gray Street Kogarah NSW 2217
Country: Australia
Tel: +61 2 93501111
Fax: +61 2 93503958
Email: hoan@sesahs.nsw.gov.au., Buccij@sesahs.nsw.gov.au

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