Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy (AFFIRM)

November 3, 2022 updated by: Radboud University Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

95

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 Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1066CX
        • Netherlands Cancer Institute
        • Contact:
          • Floris Pos, MD, PhD
          • Phone Number: +31205129111
          • Email: f.pos@nki.nl

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 to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MR-guided hypofractionated focal boost radiotherapy
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
Radiation: Ultrahypofractionated MR-guided radiotherapy boost
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute gastrointestinal and genitourinary toxicity
Time Frame: 90 days after start of treatment
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).
90 days after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late GI and GU toxicity (CTCAE v5.0)
Time Frame: from 90 days after start of treatment up to 5 years
assessed between 90 days and up to 5 years after the first radiation treatment
from 90 days after start of treatment up to 5 years
Quality of life
Time Frame: from baseline up to 5 years after completion of treatment
using the EORTC QLQ-C30 questionnaires
from baseline up to 5 years after completion of treatment
Quality of life
Time Frame: from baseline up to 5 years after completion of treatment
using the EORTC QLQ-PR25 questionnaires
from baseline up to 5 years after completion of treatment
Biochemical disease free survival
Time Frame: up to 5 years after completion of treatment
measuring the PSA concentration using the Phoenix definition for biochemical recurrence
up to 5 years after completion of treatment
Overall survival
Time Frame: up to 5 years after completion of treatment
up to 5 years after completion of treatment
Prostate cancer specific survival
Time Frame: up to 5 years after completion of treatment
up to 5 years after completion of treatment
Distant metastasis free survival
Time Frame: up to 5 years after completion of treatment
up to 5 years after completion of treatment

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

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 (ANTICIPATED)

December 1, 2022

Primary Completion (ANTICIPATED)

July 1, 2024

Study Completion (ANTICIPATED)

July 1, 2029

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (ACTUAL)

May 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL79869.091.22

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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