Back to resultsAddition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy (AFFIRM)
Primary Purpose
Prostate Cancer, Prostate Neoplasm
Status
Not yet recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Ultrahypofractionated MR-guided radiotherapy boost
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Men aged 18 years or older with histologically proven prostate carcinoma
- Imaging stage T3b (as defined on mpMRI) N0M0
- Intraprostatic lesion visible on MRI
- Capable of giving informed consent
Exclusion Criteria:
- History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
- Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
- Absence of pre-treatment PSMA PET CT
- WHO performance score > 2
- International Prostate Symptom Score ≥ 15
- PSA > 30
- Prostate volume >100c
Sites / Locations
- Radboudumc
- Netherlands Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MR-guided hypofractionated focal boost radiotherapy
Arm Description
External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MR
Outcomes
Primary Outcome Measures
Acute gastrointestinal and genitourinary toxicity
Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Acute toxicity is defined as toxicity occurring within 90 days after the first radiation treatment (e.g. 60 days after completion of the radiation treatment).
Secondary Outcome Measures
Late GI and GU toxicity (CTCAE v5.0)
assessed between 90 days and up to 5 years after the first radiation treatment
Quality of life
using the EORTC QLQ-C30 questionnaires
Quality of life
using the EORTC QLQ-PR25 questionnaires
Biochemical disease free survival
measuring the PSA concentration using the Phoenix definition for biochemical recurrence
Overall survival
Prostate cancer specific survival
Distant metastasis free survival
Full Information
NCT ID
NCT05373316
First Posted
May 5, 2022
Last Updated
November 3, 2022
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05373316
Brief Title
Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
Acronym
AFFIRM
Official Title
Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life.
This focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR-guided hypofractionated focal boost radiotherapy
Arm Type
Experimental
Arm Description
External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MR
Intervention Type
Radiation
Intervention Name(s)
Ultrahypofractionated MR-guided radiotherapy boost
Intervention Description
External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MRI.
Primary Outcome Measure Information:
Title
Acute gastrointestinal and genitourinary toxicity
Description
Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Acute toxicity is defined as toxicity occurring within 90 days after the first radiation treatment (e.g. 60 days after completion of the radiation treatment).
Time Frame
90 days after start of treatment
Secondary Outcome Measure Information:
Title
Late GI and GU toxicity (CTCAE v5.0)
Description
assessed between 90 days and up to 5 years after the first radiation treatment
Time Frame
from 90 days after start of treatment up to 5 years
Title
Quality of life
Description
using the EORTC QLQ-C30 questionnaires
Time Frame
from baseline up to 5 years after completion of treatment
Title
Quality of life
Description
using the EORTC QLQ-PR25 questionnaires
Time Frame
from baseline up to 5 years after completion of treatment
Title
Biochemical disease free survival
Description
measuring the PSA concentration using the Phoenix definition for biochemical recurrence
Time Frame
up to 5 years after completion of treatment
Title
Overall survival
Time Frame
up to 5 years after completion of treatment
Title
Prostate cancer specific survival
Time Frame
up to 5 years after completion of treatment
Title
Distant metastasis free survival
Time Frame
up to 5 years after completion of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men aged 18 years or older with histologically proven prostate carcinoma
Imaging stage T3b (as defined on mpMRI) N0M0
Intraprostatic lesion visible on MRI
Capable of giving informed consent
Exclusion Criteria:
History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
Absence of pre-treatment PSMA PET CT
WHO performance score > 2
International Prostate Symptom Score ≥ 15
PSA > 30
Prostate volume >100c
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casper Reijnen, MD, PhD
Phone
003124 361 4505
Email
casper.reijnen@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Kerkmeijer, MD, PhD
Phone
003124 361 4505
Email
linda.kerkmeijer@radboudumc.nl
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525GA
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Kerkmeijer, MD, PhD
Phone
+31243614505
Email
linda.kerkmeijer@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Casper Reijnen, MD, PhD
Phone
+31243614505
Email
casper.reijnen@radboudumc.nl
Facility Name
Netherlands Cancer Institute
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Floris Pos, MD, PhD
Phone
+31205129111
Email
f.pos@nki.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
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