ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

Treatment: Devices

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group, all patients will have stereotactic radiotherapy

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At weekly or second weekly review and after each group of patients have completed radiotherapy treatment

Primary outcome [2]

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]

At weekly or second weekly review and after each group of patients have completed radiotherapy treatment

Primary outcome [3]

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]

At weekly or second weekly review and after each group of patients have completed radiotherapy treatment

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Northern Sydney Local Health District-Royal North Shore Hospital

Address [1]

Level 1, Northern Sydney Cancer Centre
Acute Services Building, Royal North Shore Hospital, Pacific Highway St Leonards NSW 2065

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Research Office

Ethics committee address [1]

Kolling Building, Level 13, Royal North Shore Hospital, St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2016

Approval date [1]

15/03/2017

Ethics approval number [1]

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

A/Prof George Hruby

Address

Department of Radiation Oncology
Level 1, Northern Sydney Cancer Centre
Acute Services Building, Royal North Shore Hospital, Pacific Highway St Leonards NSW 2065

Country

Australia

Phone

+61 2 9463 1310

Fax

+61 2 9463 1087

george.hruby@health.nsw.gov.au

Contact person for public queries

Name

Carol kwong

Address

Department of Radiation Oncology
Level 1, Northern Sydney Cancer Centre
Acute Services Building, Royal North Shore Hospital, Pacific Highway St Leonards NSW 2065

Country

Australia

Phone

+61 2 9463 1339

Fax

+61 2 9463 1087

carolyn.kwong@health.nsw.gov.au

Contact person for scientific queries

Name

George Hruby

Address

Department of Radiation Oncology
Level 1, Northern Sydney Cancer Centre
Acute Services Building, Royal North Shore Hospital, Pacific Highway St Leonards NSW 2065

Country

Australia

Phone

+61 2 9463 1310

Fax

+61 2 9463 1087

george.hruby@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Interim Results of a Prospective Prostate-Specific Membrane Antigen-Directed Focal Stereotactic Reirradiation Trial for Locally Recurrent Prostate Cancer.	2020	https://dx.doi.org/10.1016/j.ijrobp.2020.07.014
Embase	Salvage stereotactic body radiotherapy (SBRT) for intraprostatic relapse after prostate cancer radiotherapy: An ESTRO ACROP Delphi consensus.	2021	https://dx.doi.org/10.1016/j.ctrv.2021.102206

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically