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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03073278
Registration number
NCT03073278
Ethics application status
Date submitted
27/02/2017
Date registered
8/03/2017
Date last updated
18/11/2023
Titles & IDs
Public title
Focal Radiotherapy for Previously Treated Prostate Cancer Patients
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Scientific title
Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate
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Secondary ID [1]
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Focal SBRT prostate
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Locally Recurrent Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Stereotactic Body Radiotherapy
Other: Group 1 - This group of 12 patients will be given 36Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.
Other: Group 2 - This group (12 patients) will be given 38Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.
Other: group 3 - This group (12 patients) will be given 40Gy of Stereotactic Body Radiotherapy (SBRT) divided into six separate doses. This will be delivered two to three time per week.
Treatment: Other: Stereotactic Body Radiotherapy
Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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feasibility of SBRT dose escalation. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3
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Assessment method [1]
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acute toxicity will be assessed weekly during treatment period to check whether dose escalation can be achieved
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Timepoint [1]
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at weekly review through completion of each radiothrapy dose level, approximately one year
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Primary outcome [2]
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safety of SBRT dose escalation. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3
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Assessment method [2]
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outcome will be assessed by reviewing toxicity weekly during the treatment period and at the end of each dose escalation
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Timepoint [2]
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at weekly review through completion of each radiothrapy dose level, approximately one year
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Primary outcome [3]
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Toxicity. This will be assessed by the number of participants with grade 3 acute toxicity according to CTCAE version 4.3 and RTOG toxicity score.
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Assessment method [3]
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outcome will be assessed by reviewing toxicity weekly and at the end of each dose escalation
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Timepoint [3]
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at weekly review through completion of each radiothrapy dose level, approximately one year
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Secondary outcome [1]
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Tolerability of conservation dose escalation in this cohort of patients
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Assessment method [1]
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outcome will be assessed by reviewing toxicity weekly or secondly weekly and at the end of each dose escalation
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Timepoint [1]
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After each group of patients have completed radiotherapy and at 12 and 24 months follow-up. Patients will have routine follow-up 6 monthly for 1 year and then yearly for 10 years post treatment. But study outcomes will only be collected for 2 years.
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Eligibility
Key inclusion criteria
- Men > 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of
biochemical failure or men > 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen
deprivation therapy (ADT) also used
- Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric
MRI (less than equal to cT2a)
- Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI
suspicious region.
- Life expectancy at least 10yrs from time of SBRT
- PSA < 10
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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
- Recurrence in immediate proximity to rectum (unless able to have hydrogel)
- Grade 3 or more toxicity from previous EBRT
- Contra-indicated for fiducial insertion
- GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)
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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
Other
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2027
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal North Shore Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment
(SBRT) for locally recurrent prostate cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03073278
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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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George Hruby
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Address
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Northern Sydney Local Health District
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Carolyn Kwong
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Address
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Country
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Phone
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+61 2 9463 1339
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03073278
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