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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)
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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
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Secondary ID [1]
313788
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None
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Universal Trial Number (UTN)
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Trial acronym
2SHOTS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Biopsy proven intermediate risk localised prostate cancer
336420
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Condition category
Condition code
Cancer
332941
332941
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330378
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Treatment: Other
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Comparator / control treatment
No Control Group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Acute (<3 months) effects on urinary quality of life
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Assessment method [1]
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Expanded Prostate Cancer Index Composite-26 (EPIC-26) and International Prostate Symptom Score (IPSS) questionnaire
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Timepoint [1]
340474
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4 weeks, and 3 months post SABR treatment (cumulative)
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Primary outcome [2]
340694
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Acute (<3 months) sexual quality of life
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Assessment method [2]
340694
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EPIC-26 and IPSS questionnaire
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Timepoint [2]
340694
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4 weeks, and 3 months post SABR treatment (cumulative)
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Primary outcome [3]
340691
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Acute (<3 months) bowel quality of life
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Assessment method [3]
340691
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EPIC-26 and IPSS questionnaire
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Timepoint [3]
340691
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4 weeks, and 3 months post SABR treatment (cumulative)
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Secondary outcome [1]
444209
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Prostate Specific Antigen (PSA) response (i.e. PSA <0.4ng/mL at 4 years)
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Assessment method [1]
444209
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Serum PSA levels
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Timepoint [1]
444209
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Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
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Secondary outcome [2]
444207
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Late (>6 months to 5 years) effects on quality of life
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Assessment method [2]
444207
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EPIC-26 questionnaire
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Timepoint [2]
444207
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At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
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Secondary outcome [3]
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Late (<6 months to 5 years) gastrointestinal (GI) toxicity
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Assessment method [3]
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CTCAE V5.0
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Timepoint [3]
444831
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At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
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Secondary outcome [4]
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Use of subsequent salvage androgen deprivation therapy (ADT)
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Assessment method [4]
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Assessed at follow-up and review of patient medical records
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Timepoint [4]
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Determined during follow-up at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment
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Secondary outcome [5]
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Late (<6 months to 5 years) toxicity on sexual function
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Assessment method [5]
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CTCAE V5.0
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Timepoint [5]
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At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
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Secondary outcome [6]
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Acute (<3 months) toxicity on sexual function
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Assessment method [6]
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CTCAE V5.0
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Timepoint [6]
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Week 2 during treatment, and week 4 and 3 months post SABR treatment (cumulative)
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Secondary outcome [7]
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Biochemical disease-free survival
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Assessment method [7]
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Assessed using serum PSA levels, defined by Phoenix criteria (nadir PSA + 2ng/mL)
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Timepoint [7]
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Baseline and 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
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Secondary outcome [8]
444208
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Late (<6 months to 5 years) genitourinary (GU) toxicity
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Assessment method [8]
444208
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Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
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Timepoint [8]
444208
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At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
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Secondary outcome [9]
444833
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Acute (<3 months) GU toxicity
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Assessment method [9]
444833
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Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
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Timepoint [9]
444833
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Week 2 during treatment, and week 4 and 3 months post SABR treatment (cumulative)
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Secondary outcome [10]
444830
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Late (>6 months to 5 years) effects on quality of life
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Assessment method [10]
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IPSS Questionnaire
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Timepoint [10]
444830
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At 6, 9, 12, 18, 24, 36, 48 and 60 months post SABR treatment (cumulative)
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Secondary outcome [11]
444834
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Acute (<3 months) GI toxicity
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Assessment method [11]
444834
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CTCAE V5.0
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Timepoint [11]
444834
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Week 2 during treatment, and week 4 and 3 months post SABR treatment (cumulative)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/03/2025
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Actual
26/03/2025
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Date of last participant enrolment
Anticipated
1/03/2026
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Actual
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Date of last data collection
Anticipated
1/03/2031
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Actual
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Sample size
Target
30
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27515
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
43627
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
318253
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Hospital
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Name [1]
318253
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Alfred Health Radiation Oncology Department
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Address [1]
318253
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Country [1]
318253
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Australia
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Funding source category [2]
318311
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Other
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Name [2]
318311
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RANZCR Research grant
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Address [2]
318311
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Country [2]
318311
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Australia
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Primary sponsor type
Hospital
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Name
Alfred Health
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Address
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Country
Australia
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Secondary sponsor category [1]
320639
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None
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Name [1]
320639
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Address [1]
320639
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Country [1]
320639
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316894
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
316894
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
316894
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Australia
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Date submitted for ethics approval [1]
316894
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08/01/2025
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Approval date [1]
316894
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03/02/2025
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Ethics approval number [1]
316894
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Wee Loon Ong
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Address
139346
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Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
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Country
139346
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Australia
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Phone
139346
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+61 3 90762337
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Fax
139346
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Email
139346
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[email protected]
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Contact person for public queries
Name
139347
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Wee Loon Ong
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Address
139347
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Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
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Country
139347
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Australia
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Phone
139347
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+61 3 90762337
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Fax
139347
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Email
139347
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[email protected]
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Contact person for scientific queries
Name
139348
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Wee Loon Ong
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Address
139348
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Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne VIC 3002
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Country
139348
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Australia
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Phone
139348
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+61 3 90762337
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Fax
139348
0
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Email
139348
0
[email protected]
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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.
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