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Trial registered on ANZCTR


Registration number
ACTRN12617000816358
Ethics application status
Approved
Date submitted
29/05/2017
Date registered
5/06/2017
Date last updated
7/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scans and Magnetic Resonance Imaging (MRI) to better guide high dose radiotherapy for men with high-risk prostate cancer as a means to improve clinical and quality of life outcomes.
Scientific title
The evaluation of the use of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scans and Magnetic Resonance Imaging (MRI) to better target cancer sites for men with high-risk prostate cancer requiring high dose radiotherapy as a means to improve quality of life and clinical outcomes.
Secondary ID [1] 292000 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The ROTI Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High risk prostate cancer 303401 0
Condition category
Condition code
Cancer 302813 302813 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men with high-risk prostate cancer requiring high-dose radiotherapy will have a PSMA PET scan and a MRI as part of clinical care and prior to enrollment into the study. The urologist and the radiation oncologist will assess the results of the PSMA PET scan and MRI to determine whether the patient is eligible to participate. If the patient is eligible and consents to participate, the patient will undergo a once only high dose radiotherapy (external beam radiotherapy and brachytherapy) which will target the cancer sites that were identified in the PSMA PET scan and the MRI. The dose of the radiotherapy treatment will be at the discretion of the treating radiation oncologist and urologist. The duration of the radiotherapy procedure is usually an hour however, the emission of the radiation occurs over several months following discharge from hospital. The PSMA scan, MRI and the radiotherapy treatment will occur in a participating hospital.
The men will also complete a quality of life survey prior to and at 6 weeks, 3, 6, 12, 24 and 36 months after radiotherapy treatment to determine when or whether or not they return to good health. The patient will also be reviewed by their treating doctor at 1, 3, 6, 12, 24 and 36 months post radiotherapy treatment.

Intervention code [1] 298147 0
Treatment: Devices
Intervention code [2] 298244 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302197 0
The primary outcome of this study is to determine the quality of life of men with high risk prostate whose targeted high dose radiotherapy was based on sites identified on a PSMA PET scan and MRI. Quality of life assessment will be based on the self-completed EPIC quality of life survey,
Timepoint [1] 302197 0
The quality of life survey will be completed prior to radiotherapy and then at 6 weeks, 3, 6, 12, 24 and 36 months post radiotherapy.
Secondary outcome [1] 335154 0
Morbidity will be assessed at follow up consultations by reviewing Prostate Specific Antigen (PSA) levels, any imaging results or patient reported signs and symptoms.
Timepoint [1] 335154 0
Follow-up consultations will occur at 1, 3, 6, 12, 24 and 36 months post radiotherapy.
Secondary outcome [2] 335422 0
Disease manifestation (if any) post radiotherapy treatment will be assessed at follow-up consultation reviewing Prostate Specific Antigen (PSA) levels, any imaging results or patient reported signs and symptoms. In addition, a follow-up PSMA PET scan and MRI scan will occur at three years post radiotherapy treatment to see if the cancer is still present.
Timepoint [2] 335422 0
Follow-up consultations will occur at 1, 3, 6, 12, 24 and 36 months post radiotherapy. PSMA PET scan and MRI scan three years post radiotherapy treatment.
Secondary outcome [3] 335506 0
Feasibility of using PSMA PET scans and MRI to target high-dose radiotherapy. This will be assessed by analyzing the clinical, imaging and quality of life data collected from the time of recruitment to three years post radiotherapy treatment.
Timepoint [3] 335506 0
This will be assessed when all participants have been recruited and all data have been collected. Approximately 3 years following the recruitment of the last participant.
Secondary outcome [4] 335507 0
Acute toxicity due to targeted radiotherapy treatment. This will be assessed by a CT scan to confirm the accuracy of the positioning of the brachytherapy seeds one or two days following the procedure. Follow-up consultations will also occur to assess the patient's well being by the treating clinicians.
Timepoint [4] 335507 0
The CT scan will be performed one or two days following radiotherapy treatment. Follow-up consultations will occur directly following the procedure and than at 1, 3, 6, 12, 24 and 36 months. An overall group assessment will occur at the end of the study based on clinical and quality of life data reporting. This is likely to occur three years after the recruitment of the last patient.

Eligibility
Key inclusion criteria
1. MRI: PI-RADS 4 or 5 and PSMA: SUV > 3 and
2. Gleason Score 8 to 10 with any PSA and any T stage OR
Gleason Score 6 to 7 but with PSA > 20 AND/OR T3-T4 AND/OR
N1 on imaging
3. Able to provide written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Women
* Lower grade or stage disease
* Significant post-TURP intraprostatic defect
* Significant lower urinary tract symptoms (LUTS) with an international prostatic symptom score (IPSS) >16 by 2 months prior to implant
* PSMA avid disease in bone or viscera
* PSMA or MRI evidence of nodal disease above the aortic bifurcation

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)
NIl
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NIl
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a pilot study and as such, sample size calculation has not been considered. Based on the outcomes of the pilot study, a larger study will be consider which will recruit 100 participants

Analysis plan
1: The assessment of feasibility and acute toxicity of the treatment process.
2: Biopsy- and PSMA-negative outcomes at presenting sites of disease at the 3-year time point.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
26/09/2016
Date of last participant enrolment
Anticipated
1/09/2018
Actual
4/05/2018
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
20
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8078 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 8079 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 16131 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 16132 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 296514 0
Other
Name [1] 296514 0
The Garvan Institute of Medical Research
Country [1] 296514 0
Australia
Primary sponsor type
Other
Name
The Garvan Institute of Medical Research
Address
384 Victoria St
DARLINGHURST NSW 2010
Country
Australia
Secondary sponsor category [1] 295476 0
None
Name [1] 295476 0
Address [1] 295476 0
Country [1] 295476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297735 0
St Vincent's Hospital Sydney HREC
Ethics committee address [1] 297735 0
Ethics committee country [1] 297735 0
Australia
Date submitted for ethics approval [1] 297735 0
26/05/2016
Approval date [1] 297735 0
17/08/2016
Ethics approval number [1] 297735 0
HREC/16/SVH/156

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74982 0
A/Prof Michael A Izard
Address 74982 0
The Mater Hospital
Rocklands Rd
CROWS NEST NSW 2065
Country 74982 0
Australia
Phone 74982 0
+61 2 9458 8052
Fax 74982 0
+61 2 9929 2687
Email 74982 0
michael.izard@cancer.com.au
Contact person for public queries
Name 74983 0
Quoc Nguyen
Address 74983 0
The Garvan Institute of Medical Research/ The Kinghorn Cancer Centre
370 Victoria St
DARLINGHURST NSW 2010
Country 74983 0
Australia
Phone 74983 0
+61 2 9355 5785
Fax 74983 0
+61 2 9355 5871
Email 74983 0
q.nguyen@garvan.org.au
Contact person for scientific queries
Name 74984 0
Quoc Nguyen
Address 74984 0
The Garvan Institute of Medical Research/ The Kinghorn Cancer Centre
370 Victoria St
DARLINGHURST NSW 2010
Country 74984 0
Australia
Phone 74984 0
+61 2 9355 5785
Fax 74984 0
+61 2 9355 5871
Email 74984 0
q.nguyen@garvan.org.au

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.