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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44824

Enrollment

506

Registered

2009-05-12

Start date

2009-09-21

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

The standard arm receives the current gold standard, namely 77Gy to the&nbsp

prostate in 35 fractions of 2.2 Gy, 5 times per week. In the experimental arm&nbsp

patients receive in addition to the current gold standard of 77 Gy to the&nbsp

prostate an integrated boost to the macroscopically visible tumour to reach a&nbsp

total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with intermediate or high risk local prostate cancer  WHO 0-2

Exclusion criteria

Exclusion criteria: Low risk prostate cancer  WHO score >2  If an MRI cannot be performed  IPSS score >20  Previous pelvic irradiation

Design outcomes

Primary

Measure	Time frame
To decrease the five-year biochemical relapse rate with at least 10%.	—

Secondary

Measure	Time frame
Does the addition of an ablative microboost to the macroscopic tumour within the prostate change treatment related toxicity, quality of life or disease free survival.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)