Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0

November 30, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • the Netherlands Cancer Institute
      • Nijmegen, Netherlands, 6525 GA
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypo-FLAME 2.0
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity
Time Frame: 90 days after first radiation treatment
Acute toxicity is scored using the Common Terminology Criteria Adverse Events version 5.0.
90 days after first radiation treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late toxicity
Time Frame: 10 years after first radiation treatment
Late toxicity is scored using the Common Terminology Criteria Adverse Events version 5.0.
10 years after first radiation treatment
Quality of life - general
Time Frame: 5 years after first radiation treatment
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
5 years after first radiation treatment
Quality of life - prostate specific
Time Frame: 5 years after first radiation treatment
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-PR25 questionnaire
5 years after first radiation treatment
Biochemical disease free survival
Time Frame: 10 years after first radiation treatment
Biochemical disease free survival is defined by the Phoenix consensus definition.
10 years after first radiation treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Radboud University Medical Center
The Netherlands Cancer Institute
Kom Op Tegen Kanker

Investigators

  • Principal Investigator: Karin Haustermans, M.D. PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Estimated)

February 16, 2032

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S63033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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