Clinical trial · Interventional
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer (Hypo-FLAME)
NCT02853110CI-TRIAL-00036221Hypo-FLAMEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The hypo-FLAME study is a multicenter phase II study (n=100) to investigate whether a focal SBRT boost to the MRI-defined macroscopic tumor volume is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypo-FLAME study | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypo-FLAME
- description
- External beam radiotherapy, 5 additional MRI scans, blood sampling
- interventionNames
- Radiation: Hypo-FLAME study
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- 90 days after first radiation treatment
- description
- The goal of the present study is to investigate whether a focal SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT. Toxicity will be assessed by the acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Acute toxicity is defined as toxicity occurring within 90 days after the first radiation treatment.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Men ≥ 18 years with histologically confirmed prostate adenocarcinoma * Intermediate-risk prostate cancer or high-risk prostate cancer, defined as at least one of the following risk criteria: clinical T-stage T2b, T2c or T3a (defined on MRI) or T3b with less than 5 mm invasion in the seminal vesicle, Gleason sum score ≥ 7, PSA ≥ 10 ng/mL * Prostate tumor nodule visible on MRI * Ability to give written informed consent and willingness to return for follow-up Exclusion Criteria: * Prior pelvic radiotherapy, transurethral prostate resection or prostatectomy * Unsafe to have gold fiducial marker implantation * Contraindications to MRI according to the Radiology Department guidelines (metal implants, non-compatible cardiac device, allergy to Gadolinium, severe renal dysfunction or severe claustrophobia) * Evidence of lymph node involvement or distant metastatic disease * Clinical T-stage \> T3b with ≥ 5 mm invasion in the seminal vesicle * World Health Organization (WHO) performance score \> 2 * International prostate symptoms score (IPSS score) ≥ 15 * PSA \> 30 ng/mL
References
Publications (3)
- DERIVEDDraulans C, Haustermans K, Pos FJ, van der Heide UA, De Cock L, van der Voort van Zyp J, De Boer H, Smeenk RJ, Kunze-Busch M, Monninkhof EM, De Roover R, Isebaert S, Kerkmeijer LGW. Stereotactic body radiotherapy with a focal boost to the intraprostatic tumor for intermediate and high risk prostate cancer: 5-year efficacy and toxicity in the hypo-FLAME trial. Radiother Oncol. 2024 Dec;201:110568. doi: 10.1016/j.radonc.2024.110568. Epub 2024 Oct 2. PMID 39362607
- DERIVEDGoodman CD, Fakir H, Pautler S, Chin J, Bauman GS. Dosimetric Evaluation of PSMA PET-Delineated Dominant Intraprostatic Lesion Simultaneous Infield Boosts. Adv Radiat Oncol. 2019 Sep 27;5(2):212-220. doi: 10.1016/j.adro.2019.09.004. eCollection 2020 Mar-Apr. PMID 32280821
- DERIVEDDraulans C, van der Heide UA, Haustermans K, Pos FJ, van der Voort van Zyp J, De Boer H, Groen VH, Monninkhof EM, Smeenk RJ, Kunze-Busch M, De Roover R, Depuydt T, Isebaert S, Kerkmeijer LGW. Primary endpoint analysis of the multicentre phase II hypo-FLAME trial for intermediate and high risk prostate cancer. Radiother Oncol. 2020 Jun;147:92-98. doi: 10.1016/j.radonc.2020.03.015. Epub 2020 Apr 1. PMID 32247206