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

NCT01168479 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 571

Last updated 2020-06-02

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Linda Kerkmeijer, MD, PhD · UMC Utrecht

  • Uulke van der Heide, PhD · NKI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01168479 on ClinicalTrials.gov