Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000157572
Ethics application status
Approved
Date submitted
26/04/2006
Date registered
3/05/2006
Date last updated
3/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Outcomes-analysis for localised Prostate Adenocarcinoma after Radiotherapy Treatment
Scientific 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
Universal Trial Number (UTN)
Trial acronym
POP-ART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 1130 0
Condition category
Condition code
Cancer 1208 1208 0 0
Prostate

Intervention/exposure
Study type
Interventional
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 [1] 999 0
Treatment: Devices
Comparator / control treatment
External beam RT (EBRT) alone
Control group
Active

Outcomes
Primary outcome [1] 1637 0
Anorectal Function following curative radiotherapy
Timepoint [1] 1637 0
Measured at baseline, then 6 weeks and 12 months after radiotherapy.
Primary outcome [2] 1638 0
Lower urinary tract function following curative radiotherapy
Timepoint [2] 1638 0
Measured at baseline, then 6 weeks and 12 months after radiotherapy.
Primary outcome [3] 1639 0
Quality of life following curative radiotherapy
Timepoint [3] 1639 0
Measured at baseline, then 6 weeks and 12 months after radiotherapy.
Secondary outcome [1] 2935 0
Sexual function
Timepoint [1] 2935 0
At baseline, 6 weeks and 12 months after treatment of radiotherapy.
Secondary outcome [2] 2936 0
Relapse-free survival
Timepoint [2] 2936 0
At 2 years after treatment.

Eligibility
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
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prior radiation therapy to the pelvis. Poor performance status (ECOG 2 or above).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Functional studies at baseline, 6 weeks and 12 months after radiotherapy
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1321 0
Hospital
Name [1] 1321 0
Department of radiation oncology, St George Hospital
Country [1] 1321 0
Australia
Primary sponsor type
Hospital
Name
Department of radiation oncology, St George Hospital, Kogarah 2217
Address
Country
Australia
Secondary sponsor category [1] 1166 0
None
Name [1] 1166 0
Nil
Address [1] 1166 0
Country [1] 1166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2647 0
South Eastern Sydney Health Area
Ethics committee address [1] 2647 0
Ethics committee country [1] 2647 0
Australia
Date submitted for ethics approval [1] 2647 0
Approval date [1] 2647 0
11/04/2006
Ethics approval number [1] 2647 0
06/28 Ho

Summary
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36380 0
Address 36380 0
Country 36380 0
Phone 36380 0
Fax 36380 0
Email 36380 0
Contact person for public queries
Name 10188 0
Dr Annie Ho
Address 10188 0
Department of Radiation Oncology
The St George Hospital
Gray Street
Kogarah NSW 2217
Country 10188 0
Australia
Phone 10188 0
+61 2 93501111
Fax 10188 0
+61 2 93503958
Email 10188 0
[email protected]
Contact person for scientific queries
Name 1116 0
Dr Annie Ho and Dr Joseph Bucci
Address 1116 0
Department of Radiation Oncology
The St George Hospital
Gray Street
Kogarah NSW 2217
Country 1116 0
Australia
Phone 1116 0
+61 2 93501111
Fax 1116 0
+61 2 93503958
Email 1116 0
[email protected]., [email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.