NCT04045717

Brief Summary

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).

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
67mo left

Started Apr 2020

Longer than P75 for phase_2

Geographic Reach
2 countries

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Apr 2020Feb 2032

First Submitted

Initial submission to the registry

July 19, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

April 10, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
9.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2032

Expected
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

July 19, 2019

Last Update Submit

November 30, 2023

Conditions

Prostate AdenocarcinomaProstate CancerProstate Neoplasm

Keywords

Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Acute toxicity

    Acute toxicity is scored using the Common Terminology Criteria Adverse Events version 5.0.

    90 days after first radiation treatment

Secondary Outcomes (4)

  • Late toxicity

    10 years after first radiation treatment

  • Quality of life - general

    5 years after first radiation treatment

  • Quality of life - prostate specific

    5 years after first radiation treatment

  • Biochemical disease free survival

    10 years after first radiation treatment

Study Arms (1)

Hypo-FLAME 2.0

EXPERIMENTAL

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).

Radiation: Hypo-FLAME 2.0 study

Interventions

Hypo-FLAME 2.0 studyRADIATION

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

The Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Radboudumc

Nijmegen, 6525 GA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 37178932DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Karin Haustermans, M.D. PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

August 5, 2019

Study Start

April 10, 2020

Primary Completion

June 1, 2022

Study Completion (Estimated)

February 16, 2032

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

BE(1)NL(2)