NCT04045717 is a Phase 2 clinical trial of Hypo-FLAME 2.0 study in Prostate Adenocarcinoma, sponsored by Universitaire Ziekenhuizen KU Leuven.

Who is sponsoring NCT04045717?

NCT04045717 is sponsored by Universitaire Ziekenhuizen KU Leuven.

What drugs are being tested in NCT04045717?

Interventions in NCT04045717: Hypo-FLAME 2.0 study.

What condition does NCT04045717 study?

NCT04045717 studies Prostate Adenocarcinoma, Prostate Cancer, Prostate Neoplasm.

Is NCT04045717 still recruiting?

NCT04045717 is currently active, enrolled. Last updated 1 December 2023.

Last reviewed 2023-12-01 · How we verify

NCT04045717

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0

Active, enrolled Phase 2 Last updated 1 December 2023

What this trial tests

Phase 2 trial testing Hypo-FLAME 2.0 study in Prostate Adenocarcinoma in 124 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 April 2020

Primary endpoint
1 June 2022

16 February 2032

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	124
Start date	10 April 2020
Primary completion	1 June 2022
Estimated completion	16 February 2032
Sites	3 locations across Belgium, Netherlands

Drugs / interventions tested

Hypo-FLAME 2.0 study

Conditions studied

Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →
Prostate Cancer — all drugs for Prostate Cancer →
Prostate Neoplasm — all drugs for Prostate Neoplasm →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

18 and older, male only, with Prostate Adenocarcinoma or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

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.
De Cock L, Draulans C, Pos FJ, Isebaert S, et al · · 2023 · cited 22× · PMID 37178932 · DOI 10.1016/j.radonc.2023.109713
Clinical rationale for <i>in vivo</i> portal dosimetry in magnetic resonance guided online adaptive radiotherapy.
Vivas Maiques B, Ruiz IO, Janssen T, Mans A. · · 2022 · cited 6× · PMID 35734264 · DOI 10.1016/j.phro.2022.06.005
External beam focal boost radiotherapy to intraprostatic lesions in prostate cancer: a scoping review.
Liu Y, Qin S, Ren X, Bai Y, et al · · 2026 · PMID 42093677 · DOI 10.1016/j.phro.2026.100980

Verify or expand the search:

Other recruiting trials for Prostate Adenocarcinoma

Currently open trials in the same condition.

NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
NCT06957691 — Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Pro · Phase 2 · recruiting
NCT07025369 — Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With H · Phase 2 · recruiting
NCT06967961 — Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers · NA · recruiting

Other Universitaire Ziekenhuizen KU Leuven trials

Trials by the same sponsor.

NCT06831955 — LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer · Phase 2 · recruiting
NCT07356505 — Efficacy and Safety of Micra AV2 Transcatheter Pacing System · NA · recruiting
NCT07286968 — Gastro-Intestinal Digestion and Physiology After Bariatric Surgery · recruiting
NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
NCT07270536 — Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04045717 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
Last refreshed: 1 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04045717.

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