Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000259448
Ethics application status
Approved
Date submitted
26/03/2025
Date registered
9/04/2025
Date last updated
4/06/2025
Date data sharing statement initially provided
9/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Stereotactic ablative body radiation therapy with Nodal Irradiation for ProstatE canceR(SNIPER)
Scientific title
Stereotactic ablative body radiation therapy with nodal irradiation of prostate cancer, assessing toxicities and quality of life in patients with high risk and/or node positive prostate cancer.
Secondary ID [1] 314041 0
None
Universal Trial Number (UTN)
Trial acronym
SNIPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biopsy proven high risk and/or node positive prostate cancer 336786 0
Condition category
Condition code
Cancer 333275 333275 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive stereotactic ablative radiotherapy (SABR) to the prostate and pelvic lymph nodes, delivered in five fractions, one fraction per week.

The study will recruit two cohorts of patients – Cohort A: high-risk node negative prostate cancer; Cohort B: node-positive non-metastatic prostate cancer. This study will aim to deliver SABR over 5 fractions: 36.25 Gy to the prostate, 25 Gy to the uninvolved seminal vesicle, 25 Gy to the elective pelvic nodes, (and 35 Gy to the involved node in Cohort B), one fraction per week.

SABR will be prescribed by the treating radiation oncologist.
Adherence to the intervention will be assessed by review of medical records.
Intervention code [1] 330623 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340849 0
Acute (<3 months) sexual quality of life. This will be assessed as a composite outcome
Timepoint [1] 340849 0
4 weeks, and 3 months post-completion of SABR treatment (cumulative)
Primary outcome [2] 340848 0
Acute (<3 months) bowel quality of life. This will be assessed as a composite outcome.
Timepoint [2] 340848 0
4 weeks, and 3 months post-completion of SABR treatment (cumulative)
Primary outcome [3] 340847 0
Acute (<3 months) effects on urinary quality of life. This will be assessed as a composite outcome,
Timepoint [3] 340847 0
4 weeks and 3 months post completion of SABR treatment (cumulative)
Secondary outcome [1] 445233 0
Acute (<3 months) genitourinary (GU) toxicity
Timepoint [1] 445233 0
Week 3 and 5 during treatment, and week 4 and 3 months post-completion of SABR treatment (cumulative)
Secondary outcome [2] 445236 0
Late (>6 months to 5 years) effects on quality of life
Timepoint [2] 445236 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion SABR treatment (cumulative)
Secondary outcome [3] 445246 0
Metastasis free survival
Timepoint [3] 445246 0
Determined during follow-up at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment, and if evidence of biochemical recurrence defined by Phoenix criteria (Nadir PSA + 2ng/ml)
Secondary outcome [4] 445241 0
Prostate Specific Antigen (PSA) response (i.e. PSA <0.4ng/mL at 4 years)
Timepoint [4] 445241 0
Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)
Secondary outcome [5] 445242 0
Biochemical disease-free survival
Timepoint [5] 445242 0
Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)
Secondary outcome [6] 445237 0
Late (>6 months to 5 years) effects on quality of life
Timepoint [6] 445237 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion SABR treatment (cumulative)
Secondary outcome [7] 445234 0
Acute (<3 months) gastrointestinal (GI) toxicity
Timepoint [7] 445234 0
Week 3 and 5 during treatment, and week 4 and 3 months post-completion of SABR treatment (cumulative)
Secondary outcome [8] 445245 0
Use of subsequent salvage androgen deprivation therapy (ADT)
Timepoint [8] 445245 0
Determined during follow-up at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment
Secondary outcome [9] 445238 0
Late (>6 months to 5 years) genitourinary (GU) toxicity
Timepoint [9] 445238 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)
Secondary outcome [10] 445235 0
Acute (<3 months) toxicity on sexual function
Timepoint [10] 445235 0
Week 3 and 5 during treatment, and week 4 and 3 months post-completion of SABR treatment (cumulative)
Secondary outcome [11] 445239 0
Late (>6 months to 5 years) gastrointestinal (GI) toxicity
Timepoint [11] 445239 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)
Secondary outcome [12] 445240 0
Late (>6 months to 5 years) toxicity on sexual function
Timepoint [12] 445240 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)
Secondary outcome [13] 445247 0
To determine PSA response
Timepoint [13] 445247 0
At 48 months post SABR treatment

Eligibility
Key inclusion criteria
Either
- Cohort A: Histologically confirmed intermediate risk prostate cancer (at least one high risk feature i.e. International Society of Urological Pathology (ISUP) Grade group >/= 4, serum PSA >/= 20ng/mL, clinical stage T3/4.
- Cohort B: PSMA PET confirmed pelvic node positive prostate cancer, up to 5 involved nodes.
Eastern Cooperative Oncology Group (ECOG) 0-2
Capacity to consent to treatment and comply with follow-up schedule and completion of toxicity and quality of life (QOL) questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Metastatic disease outside of pelvis (i.e. M1a, M1b, or M1c) on PSMA PET staging
- Contraindications to Magnetic Resonance Imaging (MRI)
- Prior pelvic radiotherapy or prior radical prostatectomy
- Prior pharmacologic androgen ablation for prostate cancer
- Prostate volume >100cc
- >5 pelvic lymph nodal involvement on PSMA-PET
- Severe obstructive lower urinary tract symptoms (International Prostate Symptom Score >/=20)
- Bleeding diathesis or use of anti-coagulation that is unsafe to discontinue for fiducial marker insertion.
- Comorbidities which predispose to significant radiation therapy toxicities (e.g., inflammatory bowel disease)
- Hip replacement or other pelvic metalwork that may cause artefact on diffusion-weighted magnetic resonance imaging.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2027
Actual
Date of last data collection
Anticipated
1/05/2032
Actual
Sample size
Target
60
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318548 0
Hospital
Name [1] 318548 0
Alfred Health Radiation Oncology
Country [1] 318548 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 320945 0
None
Name [1] 320945 0
Address [1] 320945 0
Country [1] 320945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317148 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317148 0
Ethics committee country [1] 317148 0
Australia
Date submitted for ethics approval [1] 317148 0
05/03/2025
Approval date [1] 317148 0
08/04/2025
Ethics approval number [1] 317148 0

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

Contacts
Principal investigator
Name 140162 0
Prof Wee Loon Ong
Address 140162 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
Country 140162 0
Australia
Phone 140162 0
+61 3 90762337
Fax 140162 0
Email 140162 0
[email protected]
Contact person for public queries
Name 140163 0
Wee Loon Ong
Address 140163 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
Country 140163 0
Australia
Phone 140163 0
+61 3 90762337
Fax 140163 0
Email 140163 0
[email protected]
Contact person for scientific queries
Name 140164 0
Wee Loon Ong
Address 140164 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
Country 140164 0
Australia
Phone 140164 0
+61 3 90762337
Fax 140164 0
Email 140164 0
[email protected]

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.