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FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Radiotherapy, MRI

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Trial Information

FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

PSA relapse is defined by the Phoenix definition (2005) as nadir +2ng/ml.

Outcome Time Frame:

Every six months for 10 years

Safety Issue:

No

Principal Investigator

Marco van Vulpen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

UMCU-FLAME

NCT ID:

NCT01168479

Start Date:

September 2009

Completion Date:

September 2019

Related Keywords:

  • Prostate Cancer
  • Radiotherapy
  • MRI
  • prostate cancer
  • external beam radiotherapy
  • dose escalation
  • dose painting
  • 95Gy in 35 fractions
  • MRI
  • FLAME
  • Prostatic Neoplasms

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