Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02004223




Registration number
NCT02004223
Ethics application status
Date submitted
25/11/2013
Date registered
9/12/2013
Date last updated
15/06/2021

Titles & IDs
Public title
Early Investigation of High Precision Radiotherapy Prior to Commencing Standard Radiotherapy for Prostate Cancer
Scientific title
Phase I Dose Escalation Study of Stereotactic BOOST for Prostate cancER
Secondary ID [1] 0 0
13-NSCCRO-P001
Universal Trial Number (UTN)
Trial acronym
BOOSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Dose escalation using stereotactic boost

Experimental: Dose escalation using stereotactic boost - Dose level allocation - Participants will be allocated to the current dose level, or if the current dose level has been filled and acceptable toxicity has been established, they will be enrolled into the next dose level


Treatment: Other: Dose escalation using stereotactic boost
This is a dose escalation study. Participants will be allocated to the current dose level, or if the current dose level has been filled and acceptable toxicity has been established, they will be enrolled into the next dose level.

The first dose level will be 20Gy in 2 fractions to PTV and 25Gy to Gross Target Volume (GTV) if identified. The second dose level will be 22Gy in 2 fractions to PTV and 27.5Gy to GTV if identified. The dose level will be 24 Gy in 2 fractions to PTV and 30Gy to GTV if identified.

Following stereotactic boost, all participants will receive 46Gy in 23 fractions radiotherapy to the prostate / seminal vesicles +/- lymph nodes.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute toxicity
Timepoint [1] 0 0
Assessed up to 12 weeks post treatment.
Secondary outcome [1] 0 0
Late toxicity
Timepoint [1] 0 0
Up to five years
Secondary outcome [2] 0 0
Cumulative toxicity rate:
Timepoint [2] 0 0
From the date of treatment completion assessed up to 5 years
Secondary outcome [3] 0 0
Biochemical failure (PSA failure)
Timepoint [3] 0 0
Up to 5 years.
Secondary outcome [4] 0 0
change in Quality of Life
Timepoint [4] 0 0
From baseline assessed up to 5 years.

Eligibility
Key inclusion criteria
* Histologically proven prostate adenocarcinoma
* PSA obtained within three months prior to enrollment.
* International Prostate Symptom Score (I-PSS) score <15
* No contraindication to MRI (pacemaker, severe claustrophobia)
* Patient must be able to have fiducial markers placed in the prostate (if on anticoagulants, must be cleared by LMO or cardiologist).
* ECOG performance status 0-2
* Ability to understand and the willingness to sign a written informed consent document.
Minimum age
35 Years
Maximum age
85 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous pelvic radiotherapy
* Prior total prostatectomy
* Unwilling or unable to give informed consent
* Unwilling or unable to complete quality of life questionnaires.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Sydney Cancer Centre, 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
Current standard treatment for prostate cancer involves giving patients approximately 40 doses of radiotherapy, one dose per day over an 8 week period. The purpose of this study is to assess the effects of giving two separate high doses of a special type of precision radiotherapy to the prostate and then 5 weeks (instead of 8 weeks) of standard radiotherapy.

Hypothesis: It is safe to give patients an extra two doses of high-precision radiotherapy prior to commencing a shorter period of standard radiotherapy for prostate cancer.
Trial website
https://clinicaltrials.gov/study/NCT02004223
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas N Eade, MBBS
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02004223