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Trial registered on ANZCTR


Registration number
ACTRN12614000858695
Ethics application status
Approved
Date submitted
31/07/2014
Date registered
11/08/2014
Date last updated
24/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A single arm, prospective Phase II study of Split-Course Pelvic
Radiotherapy for Locally Progressive, Castrate Resistant Prostate Cancer
Scientific title
A single arm, prospective Phase II study to evaluate the effect of Split-Course Pelvic Radiotherapy on bladder and bowel health related quality of life in patients with locally progressive, castrate resistant prostate cancer.
Secondary ID [1] 285085 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Castrate Resistant Prostate Cancer 292617 0
Condition category
Condition code
Cancer 292934 292934 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Split-course pelvic radiotherapy will consist of a dose of 55Gy in 22 fractions. This dose will be prescribed as a course of 25Gy in 10 fractions given over 2 weeks, followed by a planned 1 week treatment break, followed by a further 30Gy in 12 fractions given over 2 1/2 weeks.
Intervention code [1] 289925 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292796 0
The primary objective of the trial is to test the hypothesis that split-course hypo-fractionated pelvic radiotherapy improves bladder health related quality of life in patients with local symptoms associated with castrate resistant prostate cancer (CRPC).

Outcome will be assessed using the EPIC Urinary Assessment
Timepoint [1] 292796 0
6 months
Primary outcome [2] 292797 0
The co-primary objective of the trial is to test the hypothesis that split-course hypo-fractionated pelvic radiotherapy improves bowel health related quality of life in patients with local symptoms associated with castrate resistant prostate cancer (CRPC).

Outcome will be assessed using the EPIC Bowel Assessment
Timepoint [2] 292797 0
6 months
Secondary outcome [1] 309697 0
To test the hypothesis that split-course hypo-fractionated pelvic radiotherapy is associated with low rates of acute and late toxicity using NCI CTCAE Version 4
Timepoint [1] 309697 0
6 months and 3 years respectively
Secondary outcome [2] 309698 0
To test the hypothesis that split-course hypo-fractionated pelvic radiotherapy provides effective palliation of local symptoms associated with CRPC using the EPIC Urinary and Bowel Assessments
Timepoint [2] 309698 0
6 months
Secondary outcome [3] 309699 0
To determine usefulness of radiotherapy in allowing freedom from indwelling catheters or ureteric stents, preventing the need for trans-urethral resections of the prostate, bladder irrigations or blood transfusions. This will be an observational assessment using patient history to report the rates of the abovementioned interventions.
Timepoint [3] 309699 0
3 years
Secondary outcome [4] 309700 0
To determine overall survival in this patient population
Timepoint [4] 309700 0
3 years

Eligibility
Key inclusion criteria
 Aged 18 years or older

Has provided written Informed Consent for participation in this trial

Histological or cytologically confirmed prostate cancer or where diagnosis made on clinical factors, a PSA >100ug/L at diagnosis

Castrate resistant disease, as defined by a rising PSA despite castrate levels of testosterone <0.5 ug/L

Patient has symptoms attributable to local disease progression OR is asymptomatic with T3 or T4 disease but and felt to be at risk of symptomatic local progression (these patients to be included in analysis of secondary endpoints 1, 3 and 4)

An ECOG performance status score of 2 or less

Life expectancy at least 6 months

Available for follow up at least via a phone interview.

Radiotherapy can commence within 6 weeks of trial registration.

Is able to complete QOL assessments
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previous radiotherapy to the pelvis

Bilateral hip replacement surgery

Cytotoxic chemotherapy within 4 weeks of the proposed start date for radiotherapy

Prior diagnosis of cancer within 5 years of current diagnosis with the exception of successfully treated non-melanoma skin cancer

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)
The Investigator should ensure that all of the following requirements are met prior to patient enrolment:
a) The patient meets all inclusion criteria and none of the exclusion criteria apply.
b) The patient has signed and dated all applicable consent forms.
c) All baseline assessments and investigations have been performed and recorded in the patients’ medical records (i.e. source documents).
d) The registration and eligibility Case Report Form(s) (CRF) has been completed, signed and dated by the Investigator
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
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
There is limited literature on how best to manage this group of patients. Due to the relative rarity of this clinical scenario, the study investigators felt that 20 evaluable patients was sufficient to provide some prospective experience and data which will lead towards investigating the safety and tolerability of the regime. This it hoped that this experience will lead to a larger multi-centric study across Australia and New Zealand.

Baseline characteristics will be summarised in frequency tables and by the use of descriptive statistics for quantitative variables (CTCv4.0). The type I error rate is set (alpha=0.05) with 2-sided testing of p-values. The Chi–Squared test with Yates correction and student’s t-test will be used for this purpose.

Time-to-event curves for acute and late toxicity, and overall survival will be constructed using the Kaplan-Meier method with the log-rank test used to determine the magnitude of differences.

The primary endpoints will be assessed using a validated quality of life tool EPIC (Expanded Prostate Cancer Index) considering bowel & bladder domains only. A change in mean score by over 1/2 a standard deviation is considered clinically significant, called the minimum reported difference. The number of patients who achieve the minimum important difference will be presented as a percentage of total number of patients.

Cox proportional hazard models will be used to determine independent significant prognostic factors effecting disease extent.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2795 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 2796 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 8487 0
4101 - South Brisbane
Recruitment postcode(s) [2] 8488 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 8489 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 289689 0
Hospital
Name [1] 289689 0
Radiation Oncology Services - Mater
Address [1] 289689 0
31 Raymond Terrace
South Brisbane QLD 4101
Country [1] 289689 0
Australia
Funding source category [2] 289690 0
Other
Name [2] 289690 0
Royal Australia and New Zealand College of Radiologists
Address [2] 289690 0
Level 9, 51 Druitt Street, Sydney NSW 2000
Country [2] 289690 0
Australia
Primary sponsor type
Hospital
Name
Radiation Oncology Services - Mater Centre
Address
31 Raymond Terrace
South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 288385 0
None
Name [1] 288385 0
Address [1] 288385 0
Country [1] 288385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291433 0
Metro South HREC and Governance Office
Ethics committee address [1] 291433 0
Centres for Health Research
Level 7
Translational Research Institute
37 Kent Street
Woolloongabba Qld 4102
Ethics committee country [1] 291433 0
Australia
Date submitted for ethics approval [1] 291433 0
02/09/2014
Approval date [1] 291433 0
30/10/2014
Ethics approval number [1] 291433 0
HREC/14/QPAH/421

Summary
Brief summary
This study aims to prospectively evaluate the palliative benefit of a split course of pelvic radiotherapy in patients with prostate cancer whose disease is no longer responding to hormone therapy.

Who is it for?
You may be eligible to join this study if you are a male aged 18 years or above who has been diagnosed with castrate resistant prostate cancer, and are able to commence radiotherapy within 6 weeks of trial registration.

Study details
All participants in this study will undergo split-course pelvic radiotherapy, which consists of 10 treatment sessions over 2 weeks, followed by a planned 1 week treatment break, followed by a further 12 treatment sessions administered over 2.5 weeks.

Participants will be asked to complete a questionnaire at 6 months post treatment to assess bowel and bladder related quality of life. They will also be monitored for up to 3 years in order to evaluate acute and late side effects of treatment, local symptom response rate, rates of catheter removal, blood transfusions, trans-urethral prostate resections, and overall survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50342 0
Dr Kumar Gogna
Address 50342 0
Radiation Oncology Services - Mater Centre
31 Raymond Terrace
South Brisbane Qld 4101
Country 50342 0
Australia
Phone 50342 0
+61 7 3840 3255
Fax 50342 0
Email 50342 0
kumar.gogna@health.qld.gov.au
Contact person for public queries
Name 50343 0
Ms Adrienne See
Address 50343 0
Cancer Trials Unit, Division of Cancer Services
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 50343 0
Australia
Phone 50343 0
+61 7 3176 5054
Fax 50343 0
Email 50343 0
adrienne.see@health.qld.gov.au
Contact person for scientific queries
Name 50344 0
Dr Kumar Gogna
Address 50344 0
Radiation Oncology Services - Mater
31 Raymond Terrace
South Brisbane Qld 4101
Country 50344 0
Australia
Phone 50344 0
+61 7 3840 3255
Fax 50344 0
Email 50344 0
kumar.gogna@health.qld.gov.au

No data has been provided for results reporting
Summary results
Not applicable