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Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04045717
Collaborator
The Netherlands Cancer Institute (Other), Radboud University Medical Center (Other), Kom Op Tegen Kanker (Other)
124
Enrollment
3
Locations
1
Arm
142.2
Anticipated Duration (Months)
41.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Radiation: Hypo-FLAME 2.0 study
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0
Actual Study Start Date :
Apr 10, 2020
Actual Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Feb 16, 2032

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Acute toxicity [90 days after first radiation treatment]

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

Secondary Outcome Measures

  1. Late toxicity [10 years after first radiation treatment]

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

  2. Quality of life - general [5 years after first radiation treatment]

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

  3. Quality of life - prostate specific [5 years after first radiation treatment]

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

  4. Biochemical disease free survival [10 years after first radiation treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven Leuven Belgium 3000
2 The Netherlands Cancer Institute Amsterdam Netherlands 1066 CX
3 Radboudumc Nijmegen Netherlands 6525 GA

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven
  • The Netherlands Cancer Institute
  • Radboud University Medical Center
  • Kom Op Tegen Kanker

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04045717
Other Study ID Numbers:
  • S63033
First Posted:
Aug 5, 2019
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitaire Ziekenhuizen Leuven
Stereotactic Body Radiotherapy
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jun 8, 2022