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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05373316

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

47.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Neoplasm	Radiation: Ultrahypofractionated MR-guided radiotherapy boost	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

95 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2029

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Acute gastrointestinal and genitourinary toxicity [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).

Secondary Outcome Measures

Late GI and GU toxicity (CTCAE v5.0) [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
Quality of life [from baseline up to 5 years after completion of treatment]
using the EORTC QLQ-C30 questionnaires
Quality of life [from baseline up to 5 years after completion of treatment]
using the EORTC QLQ-PR25 questionnaires
Biochemical disease free survival [up to 5 years after completion of treatment]
measuring the PSA concentration using the Phoenix definition for biochemical recurrence
Overall survival [up to 5 years after completion of treatment]
Prostate cancer specific survival [up to 5 years after completion of treatment]
Distant metastasis free survival [up to 5 years after completion of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboudumc	Nijmegen	Gelderland	Netherlands	6525GA
2	Netherlands Cancer Institute	Amsterdam	Noord Holland	Netherlands	1066CX

Sponsors and Collaborators

Radboud University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radboud University Medical Center

ClinicalTrials.gov Identifier:

NCT05373316

Other Study ID Numbers:

NL79869.091.22

First Posted:

May 13, 2022

Last Update Posted:

May 20, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of May 20, 2022