Clinical trial · Interventional
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0
- 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 2.0 study is a multicenter phase II study (n=124) investigating the feasibility and safety of a reduction in the overall treatment time of radiotherapy for prostate cancer patients, making use of hypofractionated stereotactic body radiotherapy with focal boosting. We are looking for the optimal overall treatment time for this treatment strategy in the Hypo-FLAME 2.0 trial. In this study the total treatment time will be halved (15 days) in comparison with the total treatment time in the former hypo-FLAME trial (29 days) (NCT02853110).
Conditions
Conditions (3)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypo-FLAME 2.0 study | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypo-FLAME 2.0
- description
- SBRT technique with 35 Gy in 5 fractions to the whole prostate gland and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy (overall treatment time (OTT) = 15 days).
- interventionNames
- Radiation: Hypo-FLAME 2.0 study
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- 90 days after first radiation treatment
- description
- Acute toxicity is scored using the Common Terminology Criteria Adverse Events version 5.0.
Secondary outcomes (4)
- measure
- Late toxicity
- timeFrame
- 10 years after first radiation treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men ≥ 18 years with histologically confirmed prostate adenocarcinoma * Intermediate- or high-risk PCa, defined as at least one of the following risk criteria: * Clinical stage: T2b, T2c, T3a or T3b with less than 5 mm invasion in the seminal vesicles (defined on MRI) N0 M0 * Gleason sum score ≥ 7 * PSA ≥ 10 ng/mL. * Prostate tumor nodule visible on mpMRI * Ability to give written informed consent and willingness to return for follow-up Exclusion Criteria: * Prior pelvic radiotherapy or transurethral prostate resection * Unsafe to have gold fiducial marker implantation, if gold fiducial markers are used for image guidance (non MR-linac) * Contraindications to MRI according to the Radiology Department guidelines (metal implants, non-compatible cardiac device, allergy to gadolinium, severe renal dysfunction or severe claustrophobia) * World Health Organization (WHO) performance score \> 2 * International prostate symptoms score (IPSS score) ≥ 15 * PSA \> 30 ng/mL
References
Publications (1)
- DERIVEDDe Cock L, Draulans C, Pos FJ, Isebaert S, De Roover R, van der Heide UA, Smeenk RJ, Kunze-Busch M, van der Voort van Zyp J, de Boer H, Kerkmeijer LGW, Haustermans K. From once-weekly to semi-weekly whole prostate gland stereotactic radiotherapy with focal boosting: Primary endpoint analysis of the multicenter phase II hypo-FLAME 2.0 trial. Radiother Oncol. 2023 Aug;185:109713. doi: 10.1016/j.radonc.2023.109713. Epub 2023 May 11. PMID 37178932