ANZCTR - Registration

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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

13/04/2025

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]

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

Condition category

Condition code

Cancer

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Acute (<3 months) effects on urinary quality of life. This will be assessed as a composite outcome,

Timepoint [1]

4 weeks and 3 months post completion of SABR treatment (cumulative)

Primary outcome [2]

Acute (<3 months) bowel quality of life. This will be assessed as a composite outcome.

Timepoint [2]

4 weeks, and 3 months post-completion of SABR treatment (cumulative)

Primary outcome [3]

Acute (<3 months) sexual quality of life. This will be assessed as a composite outcome

Timepoint [3]

4 weeks, and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [1]

Acute (<3 months) genitourinary (GU) toxicity

Timepoint [1]

Week 3 and 5 during treatment, and week 4 and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [2]

Acute (<3 months) gastrointestinal (GI) toxicity

Timepoint [2]

Week 3 and 5 during treatment, and week 4 and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [3]

Acute (<3 months) toxicity on sexual function

Timepoint [3]

Week 3 and 5 during treatment, and week 4 and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [4]

Late (>6 months to 5 years) effects on quality of life

Timepoint [4]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion SABR treatment (cumulative)

Secondary outcome [5]

Late (>6 months to 5 years) effects on quality of life

Timepoint [5]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion SABR treatment (cumulative)

Secondary outcome [6]

Late (>6 months to 5 years) genitourinary (GU) toxicity

Timepoint [6]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)

Secondary outcome [7]

Late (>6 months to 5 years) gastrointestinal (GI) toxicity

Timepoint [7]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)

Secondary outcome [8]

Late (>6 months to 5 years) toxicity on sexual function

Timepoint [8]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)

Secondary outcome [9]

Prostate Specific Antigen (PSA) response (i.e. PSA <0.4ng/mL at 4 years)

Timepoint [9]

Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)

Secondary outcome [10]

Biochemical disease-free survival

Timepoint [10]

Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment (cumulative)

Secondary outcome [11]

Use of subsequent salvage androgen deprivation therapy (ADT)

Timepoint [11]

Determined during follow-up at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-completion of SABR treatment

Secondary outcome [12]

Metastasis free survival

Timepoint [12]

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 [13]

To determine PSA response

Timepoint [13]

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?

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

Not yet 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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alfred Health Radiation Oncology

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Alfred Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

https://www.alfredhealth.org.au/research/ethics-research-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/03/2025

Approval date [1]

08/04/2025

Ethics approval number [1]

Summary

Brief summary

This study aims to evaluate the toxicity and quality of life (QOL) outcomes associated with 5-fraction stereotactic ablative radiotherapy (SABR) for high risk and/or node positive prostate cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have high risk and/or node positive prostate cancer.

Study details:
Traditional radiotherapy for high risk and/or node positive prostate cancer typically involves four to eight weeks of daily treatment, with androgen deprivation therapy, Recent studies have shown that using fewer but larger doses of radiation, i.e. 5-treatment SABR, is just as effective and safe, and this has now become one of the standard radiotherapy schedules for intermediate risk prostate cancer. 
The question then is whether we can further reduce the number of treatments for prostate SABR while maintaining the cancer control rate and minimizing side effects for high risk and/or node positive prostate cancer. This is an appealing option from a patient convenience and healthcare cost-saving point of view.  In this Australian phase 2 trial of 5-treatment prostate and pelvic SABR, we aim to evaluate the efficacy, toxicity and quality of life outcomes of this treatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Wee Loon Ong

Address

Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002

Country

Australia

Phone

+61 3 90762337

Fax

[email protected]

Contact person for public queries

Name

Wee Loon Ong

Address

Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002

Country

Australia

Phone

+61 3 90762337

Fax

[email protected]

Contact person for scientific queries

Name

Wee Loon Ong

Address

Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002

Country

Australia

Phone

+61 3 90762337

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically