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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03073278




Registration number
NCT03073278
Ethics application status
Date submitted
27/02/2017
Date registered
8/03/2017
Date last updated
26/03/2019

Titles & IDs
Public title
Focal Radiotherapy for Previously Treated Prostate Cancer Patients
Scientific title
Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate
Secondary ID [1] 0 0
Focal SBRT prostate
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Recurrent Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 - acute toxicity will be assessed weekly during treatment period to check whether dose escalation can be achieved
Timepoint [1] 0 0
at weekly review through completion of each radiothrapy dose level, approximately one year
Primary outcome [2] 0 0
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 - outcome will be assessed by reviewing toxicity weekly during the treatment period and at the end of each dose escalation
Timepoint [2] 0 0
at weekly review through completion of each radiothrapy dose level, approximately one year
Primary outcome [3] 0 0
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. - outcome will be assessed by reviewing toxicity weekly and at the end of each dose escalation
Timepoint [3] 0 0
at weekly review through completion of each radiothrapy dose level, approximately one year
Secondary outcome [1] 0 0
Tolerability of conservation dose escalation in this cohort of patients - outcome will be assessed by reviewing toxicity weekly or secondly weekly and at the end of each dose escalation
Timepoint [1] 0 0
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.

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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
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)

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
Other
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment
(SBRT) for locally recurrent prostate cancer.
Trial website
https://clinicaltrials.gov/show/NCT03073278
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
George Hruby
Address 0 0
Northern Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carolyn Kwong
Address 0 0
Country 0 0
Phone 0 0
+61 2 9463 1339
Fax 0 0
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03073278