NCT05373316

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
35mo left

Started Dec 2022

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Dec 2022Jul 2029

First Submitted

Initial submission to the registry

May 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Expected
Last Updated

November 7, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

May 5, 2022

Last Update Submit

November 3, 2022

Conditions

Prostate CancerProstate Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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).

    90 days after start of treatment

Secondary Outcomes (7)

  • Late GI and GU toxicity (CTCAE v5.0)

    from 90 days after start of treatment up to 5 years

  • Quality of life

    from baseline up to 5 years after completion of treatment

  • Quality of life

    from baseline up to 5 years after completion of treatment

  • Biochemical disease free survival

    up to 5 years after completion of treatment

  • Overall survival

    up to 5 years after completion of treatment

  • +2 more secondary outcomes

Study Arms (1)

MR-guided hypofractionated focal boost radiotherapy

EXPERIMENTAL

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

Interventions

Ultrahypofractionated MR-guided radiotherapy boostRADIATION

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.

MR-guided hypofractionated focal boost radiotherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Casper Reijnen, MD, PhD

CONTACT

003124 361 4505casper.reijnen@radboudumc.nl

Linda Kerkmeijer, MD, PhD

CONTACT

003124 361 4505linda.kerkmeijer@radboudumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 13, 2022

Study Start

December 1, 2022

Primary Completion

July 1, 2024

Study Completion (Estimated)

July 1, 2029

Last Updated

November 7, 2022

Record last verified: 2022-05

Locations

NL(2)