Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000198426
Ethics application status
Approved
Date submitted
3/02/2025
Date registered
20/02/2025
Date last updated
30/03/2025
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] 340694 0
Acute (<3 months) sexual quality of life
Timepoint [2] 340694 0
4 weeks, and 3 months post SABR treatment (cumulative)
Primary outcome [3] 340691 0
Acute (<3 months) bowel quality of life
Timepoint [3] 340691 0
4 weeks, and 3 months post SABR treatment (cumulative)
Secondary outcome [1] 444209 0
Prostate Specific Antigen (PSA) response (i.e. PSA <0.4ng/mL at 4 years)
Timepoint [1] 444209 0
Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [2] 444207 0
Late (>6 months to 5 years) effects on quality of life
Timepoint [2] 444207 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [3] 444831 0
Late (<6 months to 5 years) gastrointestinal (GI) toxicity
Timepoint [3] 444831 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [4] 444211 0
Use of subsequent salvage androgen deprivation therapy (ADT)
Timepoint [4] 444211 0
Determined during follow-up at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment
Secondary outcome [5] 444832 0
Late (<6 months to 5 years) toxicity on sexual function
Timepoint [5] 444832 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [6] 444835 0
Acute (<3 months) toxicity on sexual function
Timepoint [6] 444835 0
Week 2 during treatment, and week 4 and 3 months post SABR treatment (cumulative)
Secondary outcome [7] 444210 0
Biochemical disease-free survival
Timepoint [7] 444210 0
Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [8] 444208 0
Late (<6 months to 5 years) genitourinary (GU) toxicity
Timepoint [8] 444208 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] 444830 0
Late (>6 months to 5 years) effects on quality of life
Timepoint [10] 444830 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
Secondary outcome [11] 444834 0
Acute (<3 months) GI toxicity
Timepoint [11] 444834 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
Recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
26/03/2025
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
1
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
Approved
Ethics committee name [1] 316894 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316894 0
Ethics committee country [1] 316894 0
Australia
Date submitted for ethics approval [1] 316894 0
08/01/2025
Approval date [1] 316894 0
03/02/2025
Ethics approval number [1] 316894 0

Summary
Brief summary
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 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.