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Trial registered on ANZCTR


Registration number
ACTRN12625000198426p
Ethics application status
Submitted, not yet approved
Date submitted
3/02/2025
Date registered
20/02/2025
Date last updated
20/02/2025
Date data sharing statement initially provided
20/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
2-fraction Stereotactic ultra-HypOfractionated radiation Therapy of the proState (2SHOTS)
Scientific title
2-fraction Stereotactic ultra-HypOfractionated radiation Therapy of the proState, assessing toxicities and quality of life in patients with intermediate risk prostate cancer
Secondary ID [1] 313788 0
None
Universal Trial Number (UTN)
Trial acronym
2SHOTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biopsy proven intermediate risk localised prostate cancer 336420 0
Condition category
Condition code
Cancer 332941 332941 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive Stereotactic Ablative Radiotherapy (SABR) to the prostate, 26Gy in 2 fractions, one week apart. Treatment will be prescribed by radiation oncologist.
Adherence to the intervention will be assessed by review of medical records.
Intervention code [1] 330378 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340474 0
Acute (<3 months) effects on urinary quality of life
Timepoint [1] 340474 0
4 weeks, and 3 months post SABR treatment (cumulative)
Primary outcome [2] 340691 0
Acute (<3 months) bowel quality of life
Timepoint [2] 340691 0
4 weeks, and 3 months post SABR treatment (cumulative)
Primary outcome [3] 340694 0
Acute (<3 months) sexual quality of life
Timepoint [3] 340694 0
4 weeks, and 3 months post SABR treatment (cumulative)
Secondary outcome [1] 444207 0
Late (>6 months to 5 years) effects on quality of life
Timepoint [1] 444207 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [2] 444208 0
Late (<6 months to 5 years) genitourinary (GU) toxicity
Timepoint [2] 444208 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [3] 444209 0
Prostate Specific Antigen (PSA) response (i.e. PSA <0.4ng/mL at 4 years)
Timepoint [3] 444209 0
Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [4] 444210 0
Biochemical disease-free survival
Timepoint [4] 444210 0
Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [5] 444211 0
Use of subsequent salvage androgen deprivation therapy (ADT)
Timepoint [5] 444211 0
Determined during follow-up at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment
Secondary outcome [6] 444830 0
Late (>6 months to 5 years) effects on quality of life
Timepoint [6] 444830 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [7] 444831 0
Late (<6 months to 5 years) gastrointestinal (GI) toxicity
Timepoint [7] 444831 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [8] 444832 0
Late (<6 months to 5 years) toxicity on sexual function
Timepoint [8] 444832 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [9] 444833 0
Acute (<3 months) GU toxicity
Timepoint [9] 444833 0
Week 2 during treatment, and week 4 and 3 months post SABR treatment (cumulative)
Secondary outcome [10] 444834 0
Acute (<3 months) GI toxicity
Timepoint [10] 444834 0
Week 2 during treatment, and week 4 and 3 months post SABR treatment (cumulative)
Secondary outcome [11] 444835 0
Acute (<3 months) toxicity on sexual function
Timepoint [11] 444835 0
Week 2 during treatment, and week 4 and 3 months post SABR treatment (cumulative)

Eligibility
Key inclusion criteria
- Histologically confirmed intermediate risk prostate cancer (at least one intermediate risk features i.e. International Society of Urological Pathology (ISUP) Grade Group 2-3, serum PSA 10-20 ng/mL, or clinical T2b/c; and no high risk features i.e., ISUP Grade Group >/= 4, serum PSA >/= 20 ng/mL, clinical T3/4)
- 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) questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Any National Comprehensive Cancer Network (NCCN) high risk features (i.e., ISUP Grade Group >/=4, serum PSA >/=20 ng/mL, clinical T3/4), or evidence of nodal or distant metastatic disease on staging prostate-specific membrane antigen (PSMA) positron emission tomography (PET)
- Contraindications to magnetic resonance imaging (MRI)
- Prior pelvic radiotherapy
- Prostate volume >100cc
- Severe obstructive lower urinary tract symptoms (IPSS >/=20)
- Bleeding diathesis or use of anti-coagulation that is unsafe to discontinue for fiducial marker and rectal-spacing gel insertion
- Comorbidities which predispose to significant radiation therapy toxicities (e.g., inflammatory bowel disease)
- Unilateral or bilateral 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
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
1/03/2025
Actual
Date of last participant enrolment
Anticipated
1/03/2026
Actual
Date of last data collection
Anticipated
1/03/2031
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27515 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 43627 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 318253 0
Hospital
Name [1] 318253 0
Alfred Health Radiation Oncology Department
Country [1] 318253 0
Australia
Funding source category [2] 318311 0
Other
Name [2] 318311 0
RANZCR Research grant
Country [2] 318311 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 320639 0
None
Name [1] 320639 0
Address [1] 320639 0
Country [1] 320639 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316894 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316894 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 316894 0
Australia
Date submitted for ethics approval [1] 316894 0
08/01/2025
Approval date [1] 316894 0
Ethics approval number [1] 316894 0

Summary
Brief summary
This study aims to evaluate the toxicity and quality of life outcomes (QOL) associated with 2-fraction stereotactic ablative radiotherapy (SABR) for localized prostate cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have intermediate risk localised prostate cancer.

Study details:
Traditional radiotherapy for prostate cancer typically involves four to eight weeks of daily treatment, 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.
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. This is an appealing option from a patient convenience and healthcare cost-saving point of view. In this Australian phase 2 trial of 2-treatment prostate SABR, we aim to evaluate the efficacy, toxicity and quality of life outcomes of 2-treatment prostate SABR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139346 0
A/Prof Wee Loon Ong
Address 139346 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
Country 139346 0
Australia
Phone 139346 0
+61 3 90762337
Fax 139346 0
Email 139346 0
[email protected]
Contact person for public queries
Name 139347 0
Wee Loon Ong
Address 139347 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
Country 139347 0
Australia
Phone 139347 0
+61 3 90762337
Fax 139347 0
Email 139347 0
[email protected]
Contact person for scientific queries
Name 139348 0
Wee Loon Ong
Address 139348 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
Country 139348 0
Australia
Phone 139348 0
+61 3 90762337
Fax 139348 0
Email 139348 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


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.