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Prostate Cancer AdenocarcinomaPhase 2Hypo-FLAMENCT02853110

Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer

A Phase 2 study testing Hypo-FLAME study in people with Prostate Cancer Adenocarcinoma, run by UMC Utrecht at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years, men only
Conditions the study is for
Prostate Cancer Adenocarcinoma
What is being tested?
Hypo-FLAME study
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesin 2 countries
Study dates
Apr 2016to 1 Nov 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Netherlands3 sites

  • NKI-AvL

    Amsterdam

  • Radboudumc

    Nijmegen

  • UMC Utrecht

    Utrecht

Other trials in Netherlands

Belgium1 site

  • UZ Leuven

    Leuven

Other trials in Belgium

About this study

Official title: Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer (Hypo-FLAME)

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.

Read the detailed description

Rationale: Hypofractionation with a stereotactic body radiotherapy (SBRT) technique for prostate cancer produces excellent treatment outcome in terms of survival and toxicity and is much more convenient than the current fractionation scheme. Local recurrence occurs most frequently at the site of the primary or dominant tumor location prior to treatment. Therefore dose escalation at the site of the primary tumor may improve disease control.

Objective: The main goal of this phase II study is to investigate whether a focal ablative SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT. The secondary objectives of this study are: late toxicity, quality of life (QoL) and biochemical disease free survival (bDFS). Furthermore, two side-studies are incorporated in this phase II study: 1) a weekly MRI will be performed to prepare for future MRI-guided (MR-linac) treatment without gold fiducial markers and 2) blood sampling for translational research (radiogenomics) and Biobank purposes.

Study design: Prospective multicenter interventional study on whole gland prostate SBRT using MRI for focal boost in 100 consecutive intermediate or high risk prostate cancer patients.

Study population: One hundred patients with histologically proven prostate adenocarcinoma with intermediate risk or high risk disease. Patients referred for external beam radiotherapy (EBRT) who fulfill 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 by external beam radiotherapy with a SBRT technique with 35 Gy in 5 weekly fractions and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy. In addition, patients will be asked to undergo 5 additional MRI scans (~15 min/scan) without contrast enhancement prior to each radiation session as well as blood sampling for translational research (radiogenomics) and Biobank purposes.

Main study parameters/endpoints: The primary endpoints of this study are acute gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Secondary endpoints are late GI and GU toxicity, QoL, and bDFS. Simultaneously, two side-studies will be performed, i.e. to prepare for MRI-guided radiotherapy and blood sampling for translational research (radiogenomics) and Biobank purposes.

Being tested
Hypo-FLAME study
Keywords
MRI, stereotactic body radiotherapy, hypofractionation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypo-FLAME studyRadiation

    SBRT technique with 35 Gy in 5 weekly fractions and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy. In addition, patients will be asked to undergo 5 additional MRI scans (~15 min/scan) without contrast enhancement prior to each radiation session as well as blood sampling for translational research (radiogenomics) and Biobank purposes.

Study groups in NCT02853110
Study groupRoleWhat they receive
Hypo-FLAMEExperimentalExternal beam radiotherapy, 5 additional MRI scans, blood sampling
Receives: Radiation: Hypo-FLAME study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute toxicity

    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.

    Measured: 90 days after first radiation treatment

Secondary outcomes (4)

  1. Late toxicity

    Late toxicity, assessed by the late GI and GU Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Late toxicity is defined as toxicity occurring after at least 90 days after the first radiation treatment.

    Measured: 10 years after last radiation treatment

  2. Quality of life - general

    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

    Measured: 5 years after last radiation treatment

  3. Biochemical disease free survival (bDFS)

    Biochemical disease free survival

    Measured: 10 years after last radiation treatment

  4. Quality of life - prostate specific

    EORTC QLQ- PR25 questionnaire

    Measured: 5 years after last radiation treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02853110
Sponsor's protocol ID
NL53719.041.15a
Acronym
Hypo-FLAME
Status last verified
Dec 2018
First submitted
24 Jun 2016
Last updated
20 Dec 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Draulans 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.

    PubMed 39362607

  • Goodman 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.

    PubMed 32280821

  • Draulans 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.

    PubMed 32247206

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypo-FLAME study in people with Prostate Cancer Adenocarcinoma, run by UMC Utrecht at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity (time frame: 90 days after first radiation treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02853110, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.

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