NCT02853110

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2016

Geographic Reach
2 countries

4 active sites

Status
completed

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 Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

2.6 years

First QC Date

June 24, 2016

Last Update Submit

December 18, 2018

Conditions

Prostate Cancer Adenocarcinoma

Keywords

MRI, stereotactic body radiotherapy, hypofractionation

Outcome Measures

Primary Outcomes (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.

    90 days after first radiation treatment

Secondary Outcomes (4)

  • Late toxicity

    10 years after last radiation treatment

  • Quality of life - general

    5 years after last radiation treatment

  • Biochemical disease free survival (bDFS)

    10 years after last radiation treatment

  • Quality of life - prostate specific

    5 years after last radiation treatment

Other Outcomes (2)

  • MRI side study

    Within 5 weeks from start of radiotherapy

  • Blood sampling

    Within 5 weeks from start of radiotherapy

Study Arms (1)

Hypo-FLAME

EXPERIMENTAL

External beam radiotherapy, 5 additional MRI scans, blood sampling

Radiation: Hypo-FLAME study

Interventions

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.

Hypo-FLAME

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UZ Leuven

Leuven, Belgium

Location

NKI-AvL

Amsterdam, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 32280821DERIVED

  • 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.

    PMID: 32247206DERIVED

Study Officials

  • Linda GW Kerkmeijer, MD, PhD

    UMC Utrecht

    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
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 24, 2016

First Posted

August 2, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations

NL(3)BE(1)