Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
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
Query!
Scientific title
Phase I Dose Escalation Study of Stereotactic BOOST for Prostate cancER
Query!
Secondary ID [1]
0
0
13-NSCCRO-P001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
BOOSTER
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Acute toxicity
Query!
Assessment method [1]
0
0
Portion of patients with grade 3 or greater genitourinary or gastrointestinal toxicity assessed using the Modified Radiation Therapy Oncology Group (RTOG) Toxicity Scale.
Query!
Timepoint [1]
0
0
Assessed up to 12 weeks post treatment.
Query!
Secondary outcome [1]
0
0
Late toxicity
Query!
Assessment method [1]
0
0
At a median follow up of 18 months, Kaplan Meir statistics will be used to estimate the 2 year late Gastrointestinal and Genitourinary Toxicity using the modified RTOG scale.
Query!
Timepoint [1]
0
0
Up to five years
Query!
Secondary outcome [2]
0
0
Cumulative toxicity rate:
Query!
Assessment method [2]
0
0
The cumulative incidence of treatment related Grade 2 or higher GI or GU toxicity allowing for competing risk (death without prior toxicity event) and loss to follow up (censoring).
Query!
Timepoint [2]
0
0
From the date of treatment completion assessed up to 5 years
Query!
Secondary outcome [3]
0
0
Biochemical failure (PSA failure)
Query!
Assessment method [3]
0
0
Nadir PSA at three months and over duration of follow-up. This will be compared to historical controls from our prospective database stratified by initial PSA and androgen deprivation use / duration (nil vs. short term vs. long term).
When patients have reached a median follow-up of 24 months and 48 months, actuarial Kaplan Meir statistics will be used to estimate the 3 year and 5 year freedom from biochemical failure (FFBF) using the Nadir + 2.0 definition.
Query!
Timepoint [3]
0
0
Up to 5 years.
Query!
Secondary outcome [4]
0
0
change in Quality of Life
Query!
Assessment method [4]
0
0
Patient reported QOL using the validated EPIC SF-36 questionnaire will be collected at baseline, 3 months, 9 months and 21-24 months. Analysis will be performed (a) using the mean scores, with a 10 point deterioration deemed clinically significant and (b) as a change from baseline per individual patient using the 21-24 month questionnaire. A 10-20 point deterioration will be deemed mild-moderate and a \>20 point deterioration will be deemed significant. Kaplan Meir statistics will be used to estimate the proportion of patients with a =10 point, or =20 point deterioration at appropriate time points.
Query!
Timepoint [4]
0
0
From baseline assessed up to 5 years.
Query!
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.
Query!
Minimum age
35
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
42
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Northern Sydney Cancer Centre, Royal North Shore Hospital - St Leonards
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Royal North Shore Hospital
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02004223
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Thomas N Eade, MBBS
Query!
Address
0
0
Royal North Shore Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02004223
Download to PDF