Skip to main content
OpenTrials
Completed

NCT Number: NCT01168479

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male MRI Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Radiotherapy Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University Hospitals Leuven, Leuven, Vlaans-Brabant, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLAME boost

Radiation

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 names: FLAME

Standard Arm

Radiation

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 names: normal dose

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. quality of life

    Time frame: every six months until 10 year

    Quality of life is measured by: SF-36, EORTC-C30 and EORTC-PR25.

  3. Disease specific survival

    Time frame: every 6 montths until 10 years

    Death with metastases is considered a death caused by the disease.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

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

Acronym: FLAME

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jul 23, 2010
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.