Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000224426p
Ethics application status
Submitted, not yet approved
Date submitted
29/01/2025
Date registered
28/03/2025
Date last updated
28/03/2025
Date data sharing statement initially provided
28/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Salvage sTereotactic Ablative radiotherapy for Recurrent prostate
cancer With Androgen suppression and Rectal Spacer (STARWARS)
Scientific title
Salvage sTereotactic Ablative radiotherapy for patients with Recurrent prostate cancer With Androgen suppression and Rectal Spacer, assessing toxicity and quality of life
Secondary ID [1] 313766 0
None
Universal Trial Number (UTN)
Trial acronym
STARWARS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 336379 0
Condition category
Condition code
Cancer 332903 332903 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive salvage reirradiation Stereotactic Ablative Radiotherapy (SABR) to the prostate, 35Gy in 5 fractions, one fraction per week, with rectal spacer.
Each fraction will take approximately 15 minutes.  Adherence to the intervention will be assessed using review of medical records.

All patients will also receive a 6-month course of Androgen Deprivation Therapy (ADT) starting concurrently with their radiotherapy. ADT agent used will be Goserelin 10.8mg, two injections given 3 monthly (each administered over < 1 minute), and medical records will be reviewed to assess adherence.
Intervention code [1] 330350 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340430 0
Acute (<3 months) genitourinary (GU) toxicity
Assessment method [1] 340430 0
CTCAEV5.0 will be used to assess acute GU toxicity
Timepoint [1] 340430 0
Weeks 1, 3, 5 and 13 from start of SABR treatment (cumulative)
Primary outcome [2] 340431 0
Acute (<3 months) gastrointestinal (GI) toxicity
Assessment method [2] 340431 0
CTCAEV5.0 will be used to assess acute GI toxicity
Timepoint [2] 340431 0
Weeks 1, 3, 5 and 13 from start of SABR treatment (cumulative)
Primary outcome [3] 340626 0
Acute (<3 months) effects on patient quality of life (QOL)
Assessment method [3] 340626 0
EPIC-26 questionnaire QOL domains for urinary and bowel and International Prostate Symptom Score (IPSS) will be used
Timepoint [3] 340626 0
Weeks 1, 3, 5 and 13 from start of SABR treatment (cumulative)
Secondary outcome [1] 444038 0
Late (> 6 months) GI toxicity
Assessment method [1] 444038 0
CTCAEV5.0 will be used to assess late GI toxicity
Timepoint [1] 444038 0
At 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months post SABR.
Secondary outcome [2] 444039 0
Late (> 6 months) GU toxicity
Assessment method [2] 444039 0
CTCAEV5.0 will be used to assess late GU toxicity
Timepoint [2] 444039 0
At 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months from treatment
Secondary outcome [3] 444040 0
Biochemical disease-free survival
Assessment method [3] 444040 0
Assessed using serum PSA levels, with biochemical failure defined by Phoenix criteria (PSA nadir + 2ng/mL)
Timepoint [3] 444040 0
PSA will be collected at baseline, and at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months from treatment.
Secondary outcome [4] 444041 0
Use of subsequent salvage ADT
Assessment method [4] 444041 0
Assessed at follow-up through clinical history and review of medical records
Timepoint [4] 444041 0
Determined during follow-up at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months from treatment.
Secondary outcome [5] 444640 0
Late (>6 months) effects on patient QOL
Assessment method [5] 444640 0
EPIC-26 questionnaire 'Quality of Life' domains for urinary and bowel, and International Prostate Symptom Score (IPSS) will be used to assess patient QOL
Timepoint [5] 444640 0
Assessed at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months from treatment

Eligibility
Key inclusion criteria
- Histologically confirmed locally recurrent prostate cancer
- Recurrence at least 2 years after completion of previous curative intent definitive prostate radiation therapy (2 years from end date of androgen deprivation therapy if androgen deprivation therapy was given with prostate radiation therapy)
- Able to undergo pre-treatment multiparametric magnetic resonance imaging (mpMRI) and prostate specific membrane antigen positron emission tomography/ computed tomography
(PSMA-PET/CT)
- Capacity to consent to treatment and comply with follow-up schedule and completion of toxicity and QOL questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Poor baseline urinary function (IPSS>20)
- Contraindication to MRI or PSMA-PET/CT
- Contraindication to gold-fiducial insertion or rectal spacer insertion
- Anticoagulation medication use (that is unsafe to be discontinued for fiducial marker and rectal spacer insertion)
- Bleeding diathesis (that is unsafe for fiducial marker and rectal spacer insertion)
- Evidence of pelvic nodal disease or distant metastasis on PSMA-PET/CT
- Prior ultra-hypofractionated radiation therapy (>5 Gy/ fraction)
- Castrate resistant prostate cancer – defined as PSA >3 ng/ml while testosterone <0.7nmol/l)

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27506 0
The Alfred - Melbourne
Recruitment hospital [2] 27510 0
Latrobe Regional Hospital - Traralgon
Recruitment postcode(s) [1] 43617 0
3004 - Melbourne
Recruitment postcode(s) [2] 43621 0
3844 - Traralgon

Funding & Sponsors
Funding source category [1] 318227 0
Hospital
Name [1] 318227 0
Alfred Health Radiation Oncology Centre
Country [1] 318227 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Country
Australia
Secondary sponsor category [1] 320611 0
None
Name [1] 320611 0
Country [1] 320611 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316870 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316870 0
Ethics committee country [1] 316870 0
Australia
Date submitted for ethics approval [1] 316870 0
27/11/2024
Approval date [1] 316870 0
Ethics approval number [1] 316870 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 139266 0
Dr Therese Kang
Address 139266 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC
Country 139266 0
Australia
Phone 139266 0
+61 3 90762360
Email 139266 0
th.kang@alfred.org.au
Contact person for public queries
Name 139267 0
Therese Kang
Address 139267 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC
Country 139267 0
Australia
Phone 139267 0
+61 3 90762337
Email 139267 0
th.kang@alfred.org.au
Contact person for scientific queries
Name 139268 0
Therese Kang
Address 139268 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC
Country 139268 0
Australia
Phone 139268 0
+61 3 90762337
Email 139268 0
th.kang@alfred.org.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.