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Trial registered on ANZCTR


Registration number
ACTRN12613000436774
Ethics application status
Approved
Date submitted
9/04/2013
Date registered
17/04/2013
Date last updated
3/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Study of patients with Oligometastases from Prostate cancer treated with Stereotactic Ablative Body Radiosurgery
Scientific title
A Pilot Study to assess the feasibility and tolerability of Stereotactic Ablative Body Radiosurgery in patients with Oligometastases from Prostate Cancer.
Secondary ID [1] 282149 0
Nil
Universal Trial Number (UTN)
U1111-1140-7563
Trial acronym
POPSTAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer (oligometastatic 1-3 metastases) 288653 0
Condition category
Condition code
Cancer 288993 288993 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stereotactic Ablative Body Radiosurgery (SABR) involves highly hypofractionated radiotherapy given as an ablative treatment. A single fraction of 20Gy will be the prescribed dose.
As part of this study you will be required to discuss your past medical history and progress of your prostate cancer with the doctor. A general physical examination with a focus on where the cancer has spread to is part of the study. You will have standard blood tests including your hormone levels and prostate specific antigen (PSA) level. Also as part of this study you will be required to have a special scan called an 18F-PET/CT (stands for fluoride-positron emission tomography/computer tomography) scan. This involves an injection of a radioactive chemical and then a scan to see where your prostate cancer has spread to.
If the tests show that the research study is suitable for you, and you still wish to take part, you can join the study and begin the treatment.
Prior to your stereotactic body radiotherapy you will be required to fill out quality of life and pain questionnaires. This may take up to 20 minutes of your time. You will have either a single session ofstereotactic body radiotherapy (SABR) or in the rare situation where there is not enough time available you may be required to return for two sessions (if you have two lesions) and three sessions (if you have three lesions).
In order to deliver this treatment, you will need to attend a ‘planning CT scan’ session, where you will receive a CT scan and your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be smoothly delivered when it comes to the time of treatment. This session will take between 45 minutes and 90 minutes. When the treatment starts, the total time required to deliver the treatment will be approximately one hour. All sessions are usually conducted on different days and we will contact you to give you the dates and times to attend for these sessions once they have been booked for you.
Follow-up will involve a visit at approximately 1 month, and every 3 months until two years after the radiotherapy treatment. At each visit you will be reviewed by the doctor and have a prostate blood test (PSA). At each visit you will be expected to indicate on a questionnaire if you have any pain. At the 1, 3, 12 and 24 month visits you will be expected to fill out a quality of life questionnaire which will take about 20 minutes of your time. You will have a whole body bone scan at 12 or 24 months after your treatment. At 6 months after your radiotherapy treatment you will have another 18F-PET/CT scan, which will be very similar to the scan before your treatment. The purpose of this scan is to assess the effect of the treatment on your lesion(s).
Intervention code [1] 286759 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289114 0
To assess the feasibility of SABR in prostate cancer patients with oligometastatic prostate cancer (up to 3 bone or lymph node metastases).
Feasibility will be considered to have been achieved for a given patient if both of the following conditions hold true for that patient:
a)Successful completion of treatment within 3 days of intended treatment completion
b)Image guidance verification of treatment delivery within 5mm of planned delivery.
Timepoint [1] 289114 0
After completion of SABR
Primary outcome [2] 289311 0
To assess the tolerability of SABR in prostate cancer patients with oligometastatic prostate cancer (up to 3 bone or lymph node metastases).
Tolerability will be considered to have been achieved for the overall cohort of patients recruited into the study, if:
a) No greater than 4 of 30 patients will experience a grade III or higher acute toxicity (that is within 3 months of SABR)
b) There will be no grade 5 toxicities related to SABR. Toxicity is assessed using CTCAE v4.
Timepoint [2] 289311 0
Toxicity is assessed pre-treatment and at 1, 3 and then 3 monthly after the end of treatment until 2 years.
Secondary outcome [1] 301846 0
To assess acute toxicity
Timepoint [1] 301846 0
Toxicity is assessed pre-treatment and at 1, 3 and then 3 monthly after the end of treatment until 2 years.
Toxicity is assessed using CTCAE v4.
Secondary outcome [2] 302209 0
To estimate effectiveness of treatment
Timepoint [2] 302209 0
The effectiveness of treatment will be assessed by means of the local progression free survival (LPFS) at 2 years post treatment. LPFS at 2 years will be estimated from the Kaplan-Meier curve, along with the corresponding 95% confidence interval.
Secondary outcome [3] 302210 0
To estimate the quality of life of patients before and after SABR.
Quality of life of patients will be assessed using the EORTC QLQ-C30 and QLQ-BM22 instruments. The QLQ-C30 is a cancer-specific, self-administered, structured questionnaire designed for use in clinical trials, it contains 30 questions (items). The QLQ—BM22 is a validated additional module designed for patients with bone metastases
Timepoint [3] 302210 0
Measurement of quality of life will occur at the following time points: pre-treatment, at 1, 3, 12 & 24 months after the end of treatment.
Secondary outcome [4] 302211 0
To estimate the pain rating before and after SABR
For evaluation of pain relief, the Numerical Rating Pain Scale will be used.
Timepoint [4] 302211 0
This will be done pre-treatment, day 1 of treatment, 1, 3 months and then 3 monthly for 2 years.
Secondary outcome [5] 302212 0
To determine changes in PSA following SABR.
The PSA for each individual patient will be plotted against time to show the PSA trajectory for each patient.
Timepoint [5] 302212 0
PSA will be measured pre-treatment, 1, 3 months and then 3 monthly for 2 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.
Primary prostate cancer controlled (or planned to be) by surgery or radical radiotherapy.
Bone Scan or CT Scan evidence of 1 to 3 metastases (Bone or Lymph node).
Androgen sensitive and castration-resistant prostate cancer.
An ECOG performance status score of 2 or less.
Life expectancy greater than 12 months.
Available for follow up.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previous high dose radiotherapy (Biological Equivalent Dose BED>40Gy) to the area to be treated.
Visceral Metastases (e.g. liver, lung or brain).
Chemotherapy within +/- 3 weeks of Steriotactic Ablative Body Radiotherapy (SABR).
Any change in hormonal therapy regimen within 6 weeks prior to SABR.
Evidence of Spinal Cord Compression
Lesion involving the skull.
Spinal Instability Neoplastic Score greater than or equal to 7 unless lesion reviewed by a neurosurgical service and considered stable.
Long bone Mirels score greater than or equal to 7 unless reviewed by an orthopaedic service and considered stable.
Surgical fixation of lesion required for stability.

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 patient must meet all inclusion criteria and none of the exclusion criteria.
Participant Information & Consent Form will be signed and dated.
This is a nonrandomised trial.There are no allocation concealment procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a single institution, single arm pilot study to determine feasibility and tolerability of SABR in patients with oligometastatic prostate cancer.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Primary Aim:
The point estimate for feasibility as a binary variable will be provided along with its 95% Confidence Interval (CI). Feasibility will be considered to have been achieved for a given patients if all of the following conditions hold true for that patient:
a) Successful completion of treatment within +/- 3 days of intended treatment
b) Image guidance verification of treatment delivery within 5mm
The point estimate for feasibility as a binary variable will be provided along with its 95% CI.
Tolerability will be defined as:
a)No greater than 15% of patients will experience a grade III or higher acute toxicity
b)There will be no grade 5 toxicities related to SABR
Secondary Aims:
The proportion of patients who suffer from grade 3 or higher acute toxicities will be provided along with its 95% CI. Acute toxicities monitored will include General, Gastro-intestinal, Hepato-biliary, Musculo-skeletal and Renal and urinary disorders
The effectiveness of treatment will be assessed by means of the local progression free survival (LPFS) at 2 years post treatment. LPFS at 2 years will be estimated from the Kaplan-Meier curve, along with the corresponding 95% confidence interval.
Quality of life of patients will be assessed using the EORTC QLQ-C30 and QLQ-BM22 instruments. A trained PET physician will provide a visual analysis of Na-18F PET scans. Na-18F PET response will be described at 6 and 24 months as counts and percentages with exact 95% confidence intervals.
Analysis Plan:
Two analyses are planned. The analysis for the primary endpoints will be performed after the last patient has been followed for 3 months and the analysis for the secondary endpoints will be performed after 2 years of follow-up.
The sample size of 30 patients is pragmatic. If 24 feasible cases are observed in the sample of 30, (an 80% feasibility rate) then the 90% CI for the true underlying rate is [64%, 91%]. The 95% confidence interval will be [61%, 92%].

Recruitment
Recruitment status
Completed
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)
VIC
Recruitment hospital [1] 783 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 6595 0
8006 - Abeckett Street

Funding & Sponsors
Funding source category [1] 286920 0
Charities/Societies/Foundations
Name [1] 286920 0
Prostate Cancer Foundation of Australia
Address [1] 286920 0
Level 3
39-41 Chandos St
St Leonards NSW 2065

Country [1] 286920 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place
East Melbourne
Vic 8006
Country
Australia
Secondary sponsor category [1] 285708 0
None
Name [1] 285708 0
Address [1] 285708 0
Country [1] 285708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288977 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 288977 0
St Andrews Place
East Melbourne
Vic 8006
Ethics committee country [1] 288977 0
Date submitted for ethics approval [1] 288977 0
Approval date [1] 288977 0
18/01/2013
Ethics approval number [1] 288977 0
Peter MacCallum 12/162

Summary
Brief summary
This study is assessing the feasibility and safety of Stereotactic Ablative Body Radiosurgery (SABR) in patients with metastatic prostate cancer.
Who is it for?
You may be eligible for this study if you have Prostate Cancer that has spread to lymph nodes or the bones.
Trial Details:
The research project is testing a new treatment for prostate cancer that has spread beyond the prostate to the lymph nodes or bones. The new treatment is called Stereotactic Ablative Body Radiotherapy.
Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. Stereotactic Ablative Body Radiotherapy (SABR) appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, kidney and the liver. We aim to test the ability of this new technique to control cancers arising from the prostate, and that have spread to bone or lymph nodes.
As part of this study you will be required to discuss your past medical history and progress of your prostate cancer with the doctor. A general physical examination with a focus on where the cancer has spread to is part of the study. You will have standard blood tests including your hormone levels and prostate specific antigen (PSA) level. Also as part of this study you will be required to have a special scan called an 18F-PET/CT (stands for fluoride-positron emission tomography/computer tomography) scan. This involves an injection of a radioactive chemical and then a scan to see where your prostate cancer has spread to.
If the tests show that the research study is suitable for you, and you still wish to take part, you can join the study and begin the treatment.
Prior to your stereotactic body radiotherapy you will be required to fill out quality of life and pain questionnaires. This may take up to 20 minutes of your time. You will have either a single session of stereotactic body radiotherapy (SABR) or in the rare situation where there is not enough time available you may be required to return for two sessions (if you have two lesions) and three sessions (if you have three lesions).
In order to deliver this treatment, you will need to attend a ‘planning CT scan’ session, where you will receive a CT scan and your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be smoothly delivered when it comes to the time of treatment. This session will take between 45 minutes and 90 minutes. When the treatment starts, the total time required to deliver the treatment will be approximately one hour. All sessions are usually conducted on different days and we will contact you to give you the dates and times to attend for these sessions once they have been booked for you.
Follow-up will involve a visit at approximately 1 month, and every 3 months until two years after the radiotherapy treatment. At each visit you will be reviewed by the doctor and have a prostate blood test (PSA). At each visit you will be expected to indicate on a questionnaire if you have any pain. At the 1, 3, 12 and 24 month visits you will be expected to fill out a quality of life questionnaire which will take about 20 minutes of your time. You will have a whole body bone scan at 12 or 24 months after your treatment. At 6 months after your radiotherapy treatment you will have another 18F-PET/CT scan, which will be very similar to the scan before your treatment. The purpose of this scan is to assess the effect of the treatment on your lesion(s).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38598 0
Dr Farshad Foroudi
Address 38598 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
Vic 8006
Country 38598 0
Australia
Phone 38598 0
+61 3 9656 1111
Fax 38598 0
+61 3 9656 1424
Email 38598 0
farshad.foroudi@petermac.org
Contact person for public queries
Name 38599 0
Dr Farshad Foroudi
Address 38599 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
Vic 8006
Country 38599 0
Australia
Phone 38599 0
+61 3 9656 1111
Fax 38599 0
+61 3 9656 1424
Email 38599 0
farshad.foroudi@petermac.org
Contact person for scientific queries
Name 38600 0
Dr Farshad Foroudi
Address 38600 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
Vic 8006
Country 38600 0
Australia
Phone 38600 0
+61 3 9656 1111
Fax 38600 0
+61 3 9656 1424
Email 38600 0
farshad.foroudi@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary