Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0
NCT ID: NCT04045717
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
124 participants
INTERVENTIONAL
2020-04-10
2032-02-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objective: In this study we will investigate 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). Besides a potential biological advantage, the reduced overall treatment time offers benefits with respect to patient convenience.
Study population: One hundred twenty four patients with histologically proven intermediate- or high-risk prostate cancer will be included in this multicenter phase II study. Patients referred for external beam radiotherapy who fulfil the inclusion criteria and without any of the exclusion criteria will be included in the present trial after written informed consent.
Intervention: Patients will be treated with a stereotactic body radiation therapy technique up to 35 Gray in 5 fractions of 7 Gray to the whole prostate gland. Additionally a simultaneously integrated focal boost to the macroscopic tumor nodule(s) visible on MRI up to 50 Gray (10 Gray/fraction) will be delivered. Treatment fractions will be delivered twice weekly, resulting in an overall treatment time of 2,5 weeks.
Main study endpoints: The primary endpoint of this study is acute gastrointestinal and genitourinary toxicity, scored using the Common Terminology Criteria Adverse Events version 5.0. Secondary endpoints are late gastrointestinal and genitourinary toxicity, quality of life and biochemical disease free survival defined by the Phoenix consensus definition.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hypo-FLAME 2.0
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).
Hypo-FLAME 2.0 study
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hypo-FLAME 2.0 study
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Netherlands Cancer Institute
OTHER
Radboud University Medical Center
OTHER
Kom Op Tegen Kanker
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karin Haustermans, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospitals Leuven
Leuven, , Belgium
The Netherlands Cancer Institute
Amsterdam, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
De 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S63033
Identifier Type: -
Identifier Source: org_study_id