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Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045717
Recruitment Status : Active, not recruiting
First Posted : August 5, 2019
Last Update Posted : June 8, 2022
Sponsor:
Collaborators:
The Netherlands Cancer Institute
Radboud University Medical Center
Kom Op Tegen Kanker
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

Study Description
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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
Prostate Adenocarcinoma Prostate Cancer Prostate Neoplasm 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 10, 2020
Actual Primary Completion Date : June 1, 2022
Estimated Study Completion Date : February 16, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Acute toxicity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 years after first radiation treatment ]
    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

  3. 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

  4. Biochemical disease free survival [ Time Frame: 10 years after first radiation treatment ]
    Biochemical disease free survival is defined by the Phoenix consensus definition.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045717


Locations
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Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Netherlands
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Radboudumc
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
The Netherlands Cancer Institute
Radboud University Medical Center
Kom Op Tegen Kanker
Investigators
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Principal Investigator: Karin Haustermans, M.D. PhD UZ Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT04045717    
Other Study ID Numbers: S63033
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen KU Leuven:
Stereotactic Body Radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases