Early Investigation of High Precision Radiotherapy Prior to Commencing Standard Radiotherapy for Prostate Cancer (BOOSTER)
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|ClinicalTrials.gov Identifier: NCT02004223|
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : September 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Dose escalation using stereotactic boost||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose Escalation Study of Stereotactic BOOST for Prostate cancER|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
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
Radiation: 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.
- Acute toxicity [ Time Frame: Assessed up to 12 weeks post treatment. ]Portion of patients with grade 3 or greater genitourinary or gastrointestinal toxicity assessed using the Modified Radiation Therapy Oncology Group (RTOG) Toxicity Scale.
- Late toxicity [ Time Frame: Up to five years ]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.
- Cumulative toxicity rate: [ Time Frame: From the date of treatment completion assessed up to 5 years ]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).
- Biochemical failure (PSA failure) [ Time Frame: Up to 5 years. ]
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.
- Quality of Life [ Time Frame: From baseline assessed up to 5 years. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004223
|Australia, New South Wales|
|Northern Sydney Cancer Centre, Royal North Shore Hospital|
|St Leonards, New South Wales, Australia, 2065|
|Principal Investigator:||Thomas N Eade, MBBS||Royal North Shore Hospital|