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Early Investigation of High Precision Radiotherapy Prior to Commencing Standard Radiotherapy for Prostate Cancer (BOOSTER)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02004223
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Associate Professor Thomas Eade, Royal North Shore Hospital

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Dose escalation using stereotactic boost Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


  4. 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.



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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • Previous pelvic radiotherapy
  • Prior total prostatectomy
  • Unwilling or unable to give informed consent
  • Unwilling or unable to complete quality of life questionnaires.

Information from the National Library of Medicine

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


Locations
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Australia, New South Wales
Northern Sydney Cancer Centre, Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
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Principal Investigator: Thomas N Eade, MBBS Royal North Shore Hospital

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Responsible Party: Associate Professor Thomas Eade, Senior Staff Specialist (Radiation Oncology), Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT02004223     History of Changes
Other Study ID Numbers: 13-NSCCRO-P001
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

Keywords provided by Associate Professor Thomas Eade, Royal North Shore Hospital:
Prostate Cancer
Dose escalation
Stereotactic
SBRT
Hypofractionation

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases