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

Prostate Cancer Clinical Trial

— AFFIRM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05373316
• Other study ID #: NL79869.091.22
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Est. completion date: July 1, 2029

Study information

• Verified date: May 2022
• Source: Radboud University Medical Center
• Contact: Casper Reijnen, MD, PhD
• Phone: 003124 361 4505
• Email: casper.reijnen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 95
• Est. completion date: July 1, 2029
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam	Noord Holland
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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