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FLAME: Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer (FLAME)

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ClinicalTrials.gov Identifier: NCT01168479
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
L.G.W. Kerkmeijer, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE July 21, 2010
First Posted Date  ICMJE July 23, 2010
Last Update Posted Date May 1, 2019
Study Start Date  ICMJE September 2009
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care. [ Time Frame: Every six months for 10 years ]
PSA relapse is defined by the Phoenix definition (2005) as nadir +2ng/ml.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01168479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
  • Establish and compare the rates of treatment-related toxicity. [ Time Frame: Every six months until 10 years ]
    Toxicity is scored by Common Toxicity Criteria (CTC). Every grade>2 is considered severe toxicity.
  • quality of life [ Time Frame: every six months until 10 year ]
    Quality of life is measured by: SF-36, EORTC-C30 and EORTC-PR25.
  • Disease specific survival [ Time Frame: every 6 montths until 10 years ]
    Death with metastases is considered a death caused by the disease.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FLAME: Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
Official Title  ICMJE FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
Brief Summary Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35% in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility study up to appr. 85 Gy on the entire prostate has already been performed and showed acceptable toxicity when combined with adequate position verification. Higher doses to the entire prostate are expected to increase severe toxicity. As local recurrences only occur at the site of the primary macroscopic tumour area the next step in increasing the dose should be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest of the prostate to the current gold standard dose. Feasibility of this approach has been shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.
Detailed Description

Objective:

  • Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
  • Secondary study objectives: Establish and compare the rates of treatment-related toxicity, quality of life and disease-free survival.

Study design: Single blind prospective randomized controlled phase III trial.

Study population: Patients with intermediate or high risk adenocarcinoma of the prostate. Intermediate or high risk is defined according to the Ash et al. 2000 criteria as:

  • One (intermediate-risk) or more (high-risk) factors: T2, or Gleasonscore=7, or iPSA 10-20 ng/mL
  • One or more (high-risk) factors: T3, or Gleasonscore >7, or iPSA >20 ng/mL

Intervention: The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week. In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.

Main study endpoint: To decrease the five-year biochemical relapse rate with at least 10%.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients will have to fill in a quality of life questionnaire before and after the radiotherapy treatments. The risk associated with the increased dose to the macroscopic tumour is an increase of toxicity and a reduction of quality of life.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Radiotherapy
  • MRI
Intervention  ICMJE
  • Radiation: FLAME boost
    In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
    Other Name: FLAME
  • Radiation: standard arm
    The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week.
    Other Name: normal dose
Study Arms  ICMJE
  • Active Comparator: standard arm
    The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week.
    Intervention: Radiation: standard arm
  • Experimental: FLAME boost
    In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
    Intervention: Radiation: FLAME boost
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2019)
571
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2010)
566
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Prostate cancer patients scheduled for external beam radiotherapy using IMRT and fiducial marker-based position verification
  • Intermediate and high risk prostate cancer, defined by Ash et al. 2000, namely:

    • One or more factors: T2, or Gleasonscore >7, or iPSA > 10 ng/mL
    • WHO score 0-2

Exclusion Criteria:

  • Low risk prostate cancer, defined by Ash et al. 2000
  • World Heath Organisation (WHO) score >2
  • International Prostate Symptom Score (IPSS) >20
  • If for any patient related reason an MRI cannot be performed
  • If anticoagulation cannot be stopped temporarily regarding the implant of fiducial markers
  • Previous prostatectomy (except from Trans Urethral Prostatectomy (TURP))
  • TURP within 3 months from start treatment
  • Previous pelvic irradiation
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01168479
Other Study ID Numbers  ICMJE UMCU-FLAME
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party L.G.W. Kerkmeijer, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda Kerkmeijer, MD, PhD UMC Utrecht
Study Director: Uulke van der Heide, PhD NKI
PRS Account UMC Utrecht
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP