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Trial registered on ANZCTR


Registration number
ACTRN12617000035325
Ethics application status
Approved
Date submitted
6/12/2016
Date registered
9/01/2017
Date last updated
27/05/2021
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
focal radiotherapy for previously treated prostate cancer patients
Scientific title
Phase I feasibility trial of stereotactic re-irradiation of prostate cancer recurrence within the definitively irradiated prostate
Secondary ID [1] 290691 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
locally recurrent prostate cancer following definitive external beam radiotherapy 301233 0
Condition category
Condition code
Cancer 300993 300993 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants must have biopsy proven locally recurrent prostate cancer. Biopsy will be performed by a Urologist. Participants will have PSMA-PET scan and MRI in Radiology and Nuclear Medicine by experienced Radiologists in the Royal North Shore Hospital before starting stereotactic radiotherapy. Participants will require fiducial markers inserted in the prostate and may require hydrogel insertion depending on the location of the recurrence. If these are required, it will be done by experienced radiation oncologists. Fiducial markers insertion involves inserting three gold markers into the prostate. It will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment. There will be three groups of participants, each group will receive different level of radiation dose to test the safety of increasing radiotherapy dose. Group 1 will receive 36 grays (radiation dose unit) in 6 treatments. Group 2 will receive 38 grays in 6 treatments and group 3 will receive 40 grays in 6 treatments. The incremental dose escalation will cease if any excess acute or late grade 3 toxicity. Focal Stereotactic body radiation treatment (SBRT) will be delivered two to three times per week, every second day. The number of treatments per week will depend on the day of the week you start your treatment (ie ,if you start your radiotherapy on Wednesday, you will have two treatments that week etc). You will have a total of 6 treatments. Each radiotherapy session will take 30 minutes. Patients will be reviewed weekly or second weekly. Toxicity will be recorded. A Safety Committee will be formed containing multi-disciplinary team members. All serious adverse events will be reported to the Principal Investigator and HREC within 24 hours.
Intervention code [1] 296572 0
Treatment: Devices
Intervention code [2] 296776 0
Treatment: Other
Comparator / control treatment
No control group, all patients will have stereotactic radiotherapy
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300412 0
Examine the feasibility of focal stereotactic body radiation treatment (SBRT) for locally recurrent prostate cancer. Outcome will be assessed by reviewing toxicity weekly or second weekly and whether dose escalation can be achieved.
Timepoint [1] 300412 0
At weekly or second weekly review and after each group of patients have completed radiotherapy treatment
Primary outcome [2] 300471 0
Examine the safety of focal stereotactic body radiation treatment (SBRT) for locally recurrent prostate cancer. Outcome will be assessed by reviewing toxicity weekly or second weekly and at the end of each level of dose escalation.
Timepoint [2] 300471 0
At weekly or second weekly review and after each group of patients have completed radiotherapy treatment
Primary outcome [3] 300472 0
Examine the toxicity of focal stereotactic body radiation treatment (SBRT) for locally recurrent prostate cancer. Outcome will be assessed by reviewing toxicity weekly or second weekly, the number of grade 3 toxicity and whether dose escalation can be achieved .
Timepoint [3] 300472 0
At weekly or second weekly review and after each group of patients have completed radiotherapy treatment
Secondary outcome [1] 329921 0
tolerability of conservation dose escalation in this cohort of patients. Outcome will be assessed weekly/second weekly for toxicity and at the end of each dose level of escalation.
Timepoint [1] 329921 0
After each group of patients have completed radiotherapy treatment and at 12 and 24 months after completion of radiotherapy to determine early treatment success or failure . After the 24 months follow-up, patients will have routine follow-up 6 monthly for 1 year and then yearly until 10 years post treatment as per current practice.. Study outcomes will only be collected for the first 2 years after treatment.

Eligibility
Key inclusion criteria
1. Men > 4 years (yrs) from previous radiotherapy (RT) meeting the Phoenix definition of biochemical failure or men > 5yrs from RT if neo-adjuvant and/or adjuvant ADT also used
2. Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a)
3. Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region.
4. Life expectancy at least 10yrs from time of SBRT
5.PSA < 15 (within 2 months prior to enrolment)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1 Recurrence in immediate proximity to rectum (unless able to have hydrogel)
2 Grade 3 or more toxicity from previous EBRT
3 Contra-indicated for fiducial markers insertion
4 GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)

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
Other
Other design features
Dose escalation. Radiotherapy dose will only increases if the twelve patients in each group have not experienced grade 3 acute or late toxicity.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
This is a pilot study to assess feasibility and toxicity. It is powered to ensure a less than 10% acute grade 3 toxicity rate at any of the three dose levels.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2017
Actual
24/04/2017
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
28/02/2024
Actual
Sample size
Target
36
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7074 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 14801 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 295116 0
Hospital
Name [1] 295116 0
Northern Sydney Local Health District-Royal North Shore Hospital
Country [1] 295116 0
Australia
Primary sponsor type
Hospital
Name
Northern Sydney Local Health District-Royal North Shore Hospital
Address
Executive Unit, Building 51, Level 1, Southern Campus, Royal North Shore Hospital, Pacific Highway, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 293935 0
None
Name [1] 293935 0
Address [1] 293935 0
Country [1] 293935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296468 0
Northern Sydney Local Health District Research Office
Ethics committee address [1] 296468 0
Kolling Building, Level 13, Royal North Shore Hospital, St Leonards NSW 2065
Ethics committee country [1] 296468 0
Australia
Date submitted for ethics approval [1] 296468 0
28/11/2016
Approval date [1] 296468 0
15/03/2017
Ethics approval number [1] 296468 0

Summary
Brief summary
The aim of the study is to examine the feasibility, safety and toxicity of focal stereotactic body radiation treatment (SBRT) for locally recurrent prostate cancer following definitive external beam radiotherapy.
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 biopsy proven locally recurrent prostate cancer.

Study details
All participants in this study will first receive two different types of scans to locate the suspected regions of recurrence – these scans are called prostate-specific membrane antigen positron emission tomography (PSMA-PET) and magnetic resonance imaging (MRI). They will then proceed to receive six treatment sessions of Stereotactic Body Radiation Therapy (SBRT). The first 12 participants will receive a radiation dose of 36 grays (radiation dose unit). If this is tolerated, then the next 12 participants will receive a dose of 38 grays. Again if this is tolerated, then the final 12 participants will be treated at a dose of 40 grays.

After treatment, all participants will have follow-up every 4 months for the first two years, After two years patients will have routine follow-up (6 monthly for one year, then yearly thereafter until 10 years). During the follow-up period, Patients will have PSA and toxicity assessments. PSMA-PET scans will be repeated at 12 and 24 months post treatment. Study related outcomes will be collected for 2 years. After 2 years outcomes will be collected as per departmental protocol.
The study aims to combine the non-invasive advantages of SBRT re-irradiation using functional MRI plus PSMA-PET scans to define and treat the area of recurrence rather than the whole prostate gland.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70958 0
A/Prof George Hruby
Address 70958 0
Department of Radiation Oncology
Level 1, Northern Sydney Cancer Centre
Acute Services Building, Royal North Shore Hospital, Pacific Highway St Leonards NSW 2065
Country 70958 0
Australia
Phone 70958 0
+61 2 9463 1310
Fax 70958 0
+61 2 9463 1087
Email 70958 0
[email protected]
Contact person for public queries
Name 70959 0
Carol kwong
Address 70959 0
Department of Radiation Oncology
Level 1, Northern Sydney Cancer Centre
Acute Services Building, Royal North Shore Hospital, Pacific Highway St Leonards NSW 2065
Country 70959 0
Australia
Phone 70959 0
+61 2 9463 1339
Fax 70959 0
+61 2 9463 1087
Email 70959 0
[email protected]
Contact person for scientific queries
Name 70960 0
George Hruby
Address 70960 0
Department of Radiation Oncology
Level 1, Northern Sydney Cancer Centre
Acute Services Building, Royal North Shore Hospital, Pacific Highway St Leonards NSW 2065
Country 70960 0
Australia
Phone 70960 0
+61 2 9463 1310
Fax 70960 0
+61 2 9463 1087
Email 70960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
study result will be published as a group


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
SourceTitleYear of PublicationDOI
EmbaseInterim Results of a Prospective Prostate-Specific Membrane Antigen-Directed Focal Stereotactic Reirradiation Trial for Locally Recurrent Prostate Cancer.2020https://dx.doi.org/10.1016/j.ijrobp.2020.07.014
EmbaseSalvage stereotactic body radiotherapy (SBRT) for intraprostatic relapse after prostate cancer radiotherapy: An ESTRO ACROP Delphi consensus.2021https://dx.doi.org/10.1016/j.ctrv.2021.102206
N.B. These documents automatically identified may not have been verified by the study sponsor.