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Prostate AdenocarcinomaPhase 2NCT04045717

Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0

A Phase 2 study testing Hypo-FLAME 2.0 study in people with Prostate Adenocarcinoma and Prostate Cancer, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Hypo-FLAME 2.0 study
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
3 sitesin 2 countries
Study dates
10 Apr 2020to 16 Feb 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Netherlands2 sites

  • The Netherlands Cancer Institute

    Amsterdam, 1066 CX

  • Radboudumc

    Nijmegen, 6525 GA

Other trials in Netherlands

Belgium1 site

  • University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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).

Read the detailed description

Rationale: External beam radiotherapy is one of the standard treatment options for patients with prostate cancer. The overall treatment time of a standard fractionated schedule varies between 7 and 8 weeks (i.e. 35-40 fractions, 5x/week). Recent studies have identified a proportionally longer overall treatment time as a potential adverse factor for treatment outcome in prostate cancer patients who were treated by conventional radiotherapy schedules. Furthermore shortening of the overall treatment time promotes patient convenience. An extreme shortening of the overall treatment time is possible by using hypofractionated treatment schedules with simultaneous integrated intraprostatic tumor boosting to overcome local recurrences.

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.

Being tested
Hypo-FLAME 2.0 study
Keywords
Stereotactic Body Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • 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).

Study groups in NCT04045717
Study groupRoleWhat they receive
Hypo-FLAME 2.0ExperimentalSBRT 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).
Receives: Radiation: Hypo-FLAME 2.0 study

What is being measured

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

  1. Acute toxicity

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

    Measured: 90 days after first radiation treatment

Secondary outcomes (4)

  1. Late toxicity

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

    Measured: 10 years after first radiation treatment

  2. Quality of life - general

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

    Measured: 5 years after first radiation treatment

  3. Quality of life - prostate specific

    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-PR25 questionnaire

    Measured: 5 years after first radiation treatment

  4. Biochemical disease free survival

    Biochemical disease free survival is defined by the Phoenix consensus definition.

    Measured: 10 years after first 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 posted5 Aug 2019
  2. Study start10 Apr 2020
  3. Primary completion1 Jun 2022
  4. Study completion16 Feb 2032 (estimated)

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
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04045717
Sponsor's protocol ID
S63033
Status last verified
Nov 2023
First submitted
19 Jul 2019
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37178932

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypo-FLAME 2.0 study in people with Prostate Adenocarcinoma and Prostate Cancer, run by Universitaire Ziekenhuizen KU Leuven at 3 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

This study is still under way. Results are not available in the source record yet.

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 NCT04045717, which also lists 1 linked publication.

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 1 Dec 2023.

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